Evidence Based Project

Running Head: Eat, Sleep, and Console
The Effectiveness of the Eat, Sleep, and Console (ESC) Model in the
Neonatal Intensive Care Unit (NICU)
Evidence Based Project
Alaina Zehentbauer, Alice Woodruff, Daziana Velasquez, Gina Antonucci, and Michelle Bridge
Walsh University
Sharon Oetker- Black RN, PhD, JD, ANEF, FAAN
April 19, 2020

Eat, Sleep, and Console 2
Opioid abuse has been an increasing issue in the United States since the late 1990’s.
Unfortunately, as opioid use has continued to spike, the number of neonates exposed in utero has
increased following the same trend (Graham et al., 2019). In other words, “illicit substances that
cause drug dependence and addiction in the mother also cause the fetus to become addicted. At
birth, [the] baby’s dependence on the substance continues. However, since the drug is no longer
available, the baby’s central nervous system becomes overstimulated causing the symptoms of
withdrawal” (“Illegal Drug Use and Pregnancy,” n.d., p. 1). As a result, infants born to mothers
who use opioids during pregnancy may develop Neonatal Abstinence Syndrome (NAS). Simply
put, NAS refers to a “constellation of neurologic, gastrointestinal, and musculoskeletal
disturbances associated with opioid withdrawal” (Grossman et al., 2018, p. 1). In general, infants
who are at risk for NAS must be carefully monitored in the hospital.
“Symptoms in newborns usually occur 48 to 72 hours after birth, which may include
tremors, irritability, excessive or high-pitched crying, sleep problems, hyperactive reflexes,
seizures, yawning, stuffy nose, sneezing, poor feeding and sucking, vomiting, loose stools,
dehydration, and increased sweating. These symptoms are based on certain factors such as the
type and amount of substance the newborn was exposed to before birth, the last time a substance
was used, whether the baby is born full-term or premature, and if the newborn was exposed to
more than one substance before birth” (“Basics About Opioid Use,” n.d., p. 3). Statistically
speaking “in 2014 a baby was born with NAS every 15 minutes. This means that nearly 100
babies a day were born with NAS, which is about 32,000 babies in a year” (“Data and Statistics,”
2019, p. 1). As a result, in 2015, the United States Drug Enforcement Administration released a
statement classifying the level of opioid abuse as an epidemic and a direct threat to public health.
Interestingly, while floating amongst the various Neonatal Intensive Care Units (NICU’s)
and Special Care Nursery’s (SCN’s), which is a sub-intensive unit of the NICU at Akron
Children’s Hospital it became evident that the way in which NAS babies were being treated
differed across the campuses. For instance, at the Mahoning Valley campus, a relatively new
strategy called the Eat, Sleep, and Console (ESC) model was recently implemented in
conjunction with using the traditional Finnegan Neonatal Abstinence Scoring System (FNASS).
As such, the purpose of this research paper then is to provide a comprehensive overview of the
ESC model and determine its overall effectiveness. In order to achieve this goal, a total of fifteen
research articles have been gathered from various scholarly resources including CINAHL, Ovid,
and Google Scholar, which are presented in the appendix, and a number of interviews were also
conducted with a group of individuals at the Mahoning Valley campus including neonatologists,
nurse practitioners, nurses, and nurse educators. In addition to discussing the ESC model, an
evaluation of the current use of research findings will be addressed as well. Lastly, based on this
research, a recommended course of action for nursing practice and future research will be
discussed.
In general, the ESC model was developed in 2011 by Matthew Grossman, MD and his
colleagues at Yale-New Haven Children’s Hospital and was based on years of observation of
patients with NAS. Overall, this group considered eating and sleeping to be the essential
functions of a newborn. Simply put, the ESC model is based off of “if the infant is able to eat ≥ 1
oz per feed or breastfeeding well, to sleep undisturbed ≥ 1 hour, and to be consoled, if crying,
within 10 minutes” (Grossman et al., 2017, p. 3). Therefore, if these functions were not
interrupted by withdrawal symptoms, then it was considered that the infant’s withdrawal
symptoms were being well managed. By contrast “if the infant was eating < 1 oz per feed or not
breastfeeding well, sleeping < 1 hour undisturbed, and/or was not consolable within 10 minutes,
the medical team was alerted, and the treatment was increased either by augmenting
nonpharmacologic interventions, if possible, or starting morphine at 0.05 mg/kg every 3 hours”
(Grossman et al., 2017, p. 3). However, roughly 98 percent of hospitals nationwide use the
Finnegan Neonatal Abstinence Scoring System (FNASS) instead (Grossman, 2018). The FNASS
is a “31 item scale that is designed to quantify the severity of NAS and to guide treatment, and is
administered every 4 hours. The individual NAS symptoms are weighted (numerically scoring
1–5) depending on the symptom and the severity of the symptom expressed. Infants scoring an 8
or greater are recommended to receive pharmacologic therapy” (Jansson et al., 2019, p. 3). That
being said, the PICO question that guided the research was - in NAS babies how does the ESC
method compare to the sole use of the Finnegan scale affect pharmacological use during an
infant’s length of stay in the NICU/SCN?
As previously mentioned, the vast majority of hospitals in the United States use the
Finnegan scale. In 2012, four to five percent of NICU beds were filled with NAS babies.
Moreover, in some community hospitals, this number could be anywhere as high as fifty percent
(Grossman, 2018). In addition, the average length of stay around the county using the Finnegan
scale was roughly three weeks (Grossman, 2018). As such, it is not surprising then, that outside
of prematurity – NAS babies were deemed to have the longest length of stay in pediatrics
(Grossman, 2018). One reason for this is because the standard approach for treating NAS babies
generally involves five tenants including (1) medications being the key to treatment, (2) NAS
babies mostly being managed in NICU’s, SCN’s, and general pediatric floors, or a combination
of the three (3) the Finnegan scores driving the treatment, (4) medication needing to be slowly
weaned, (5) and staff caring for the babies (Grossman, 2018).
With regard to medication, majority of the research has been geared towards figuring out
what the right medication or combination of medications should be used to treat these babies.
Currently, roughly 60 to 70 percent of hospitals will use morphine as the first line agent
(Grossman, 2018). However, according to Disher et al (2019) “morphine was consistently among
the least effective treatments” (p. 240). Further, according to Kraft et al (2017) “sublingually
administered buprenorphine was significantly more effective than oral morphine in reducing the
duration of treatment for the neonatal abstinence syndrome, which translated into a shorter
hospital stay” (p. 2348). Also, according to a study conducted by Hall et al (2016) “analysis
demonstrated shorter duration of opioid treatment and briefer length of inpatient stay for infants
that received sublingual buprenorphine compared with conventional oral methadone
pharmacotherapy for NAS” (p. 42). By contrast, Brown Medical School in 2002 focused on
testing the hypothesis that “treatment of neonatal opiate withdrawal (NOW) in the term infant
with diluted tincture of opium (DTO) and phenobarbital was superior to treatment with DTO
alone” (Coyle, 2002, p. 561).
Overall, the length of stay for babies receiving tincture opium ranged between 17 days to
79 days, (Grossman, 2018), the range of oral morphine was 8 +/-5 days with a range of 2.8 to 21
days (Nayeri et al., 2015), and the phenobarbital group was 8.5 +/-4 days with a range of 4 to
21.2 days (Nayeri et al., 2015). The question presented then became - what type of other disease
process has this type of length of stay? According to Grossman and his colleagues at Yale-New
Haven Children’s Hospital, the answer is – there is none. Further according to the American
Academy of Pediatrics clinical report on neonatal withdrawal “drug therapy is indicated to
relieve moderate to severe signs of NAS and to prevent complications such as fever, weight loss,
and seizures if an infant does not respond to a committed program of non-pharmacologic
support. Since the introduction of the abstinence scales in 1975 […] no studies to date have
compared the use of different withdrawal score thresholds for initiating pharmacologic
intervention on short-term outcomes” (Hudak & Tan, 2012, p. 548). However, a study conducted
by Hendree et al (2016) compared psychometric characteristics of the Neonatal Abstinence
Scoring System and the Mother NAS scale and found “inadequacies in regard to their basic
measurement characteristics” (p. 371).
In addition, one of the biggest disadvantages of using the Finnegan scale is that babies
who are not going through withdrawal also sneeze and yawn as well, which per the scale can be
considered one point. Therefore, the question of whether the symptoms are being attributed to
withdrawal, or solely just being a baby is nearly impossible to differentiate between. However,
the cost of an additional sneeze or yawn - could result in the baby having a score of an eight
instead of a seven for three consecutive times. As such, once this occurs - it would result in the
administration of morphine. After the initial dose, the number of doses from there can range
between 80 to 100 doses because the drug needs to be slowly weaned (Grossman, 2018).
Therefore, based on this data - Akron Children’s Hospital Mahoning Valley NICU/SCN
implemented the ESC model.
Based on the hospital’s policy #12067 “it is the responsibility of the nursing staff to
assess the infant for neonatal withdrawal symptoms using the tools outlined and to communicate
the results with the clinical coordinator and or physician/Advanced Practice Provider (APP).
Also, it is the responsibility of the physician/APP to order pharmacologic treatment for
withdrawal following policy guidelines” (“NAS Mahoning Valley Campus,” 2019, p. 2). When
it comes to pharmacologic use, it is important to note “special consideration must be taken for
the late preterm infant who may not be able to feed by bottle/breast feed. In that case, the
physician/APP (provider team) will consider the “Sleep” and “Console” portions of the Comfort
Assessment Tool” (“NAS Mahoning Valley Campus,” 2019, p. 8). Overall, the nurse will
document the Comfort Assessments on the MV NAS flowsheet in EPIC. In general, the Comfort
Assessment Tool is considered to be a “kinder, gentler approach to NAS assessments” (“NAS
Mahoning Valley Campus,” 2019, p. 4). In addition to answering whether an infant can eat
effectively, sleep for an hour, and be consoled in 10 minutes - a nurse must also monitor the
infants’ vital signs every six to eight hours, perform a daily weight, and monitor the use of an
oximeter only if the infant is on buprenorphine or morphine, until dose is being weaned,
provided there is no clinical apnea/bradycardia. Nonetheless, even though nurses continue to
document using the Finnegan Score “all clinical decisions will be based on comfort assessments
results documented on the Comfort Assessment Tool” (“NAS Mahoning Valley Campus,” 2019,
p. 5).
Based on an interview with the Neonatal Clinical Practice Leader/PI Coordinator at the
Mahoning Valley Campus, early on this approach was met with some resistance from the nursing
staff; however, over the course of a few short months nurses began to realize non-pharmacologic
measures were proving to be effective. In addition, per the neonatologists at the campus it also
improved parent engagement as mothers were now being considered the “antibiotics” to treat the
condition, or withdrawal symptoms. In addition, other disadvantages nurses noted when using
the Finnegan scale included disturbing the infant and exacerbating signs of withdrawal in effort
to obtain a score, long length of stays, and a lot of powerful and potentially harmful medications
being used. In other words, a NAS baby could be sleeping calmly; however, in effort to score for
moro reflex - an assessment would need to occur. As such, nurses felt as though they were
actively doing more harm. Further, these babies would be assessed every three hours and it was
not until eight hours later they would be able to treat them with medication(s).
On the other hand, in terms of education there are a number of neonatal as well as social
work textbooks that describe this model. In addition, there is also a number of research articles
ranging from literature reviews to retrospective studies as well as a number of informative
webinars. As such, with more publications coming out and more grants being available to
determine long-term outcomes - it is likely to see more hospitals beginning to implement this
approach. However, with regard to Akron Children’s Hospital Mahoning Valley NICU/SCN
itself – the staff nurses received monthly education in January on the model that included a
required quiz in order to ensure proper understanding of the Comfort Assessment Tool. With
regard to parents/legal guardians – it is a collaborative effort to ensure that they are properly
educated on the ESC model and understand how to properly swaddle, are aware of safe sleep
recommendations, and understand what baby cues are and how to respond to each of them.
Lastly, with regard to the ethical/cultural implications of these findings - it is evident how
this model helps facilitate and support parent engagement. For instance, there is often a stigma
that is associated with the disease of addiction. Therefore, parent(s) can often feel guilt and
shame witnessing withdrawal symptoms as well as feel helpless and judged (Scull & Weise, n.d.,
p. 16), which leads to barriers of attachment. However, instead of separating the parent(s) and
infant, the ESC model instead brings them together. By doing so, a nurse is able to engage a
mother in the care of her infant. In addition, a nurse can encourage the parents to feed as well as
support touching the baby through bathing and infant massage. As such, these tasks can result in
an increase in trust, confidence, and a reparative relationship. Moreover, it is a collaborative
effort to ensure that family centered care is being delivered at Akron Children’s Hospital
Mahoning Valley. This is achieved through “creating a secure and comfortable environment,
caring with a non-judgmental approach, treating the infant and mother as a dyad, supporting
breastfeeding and rooming-in, and collaborating with social work, physical therapy, and
occupational therapy” (Bear et al., n.d., p. 59). Interestingly, when it comes to rooming-in, a
study conducted by Newman et al (2015) revealed that “the requirement for oral morphine
therapy for the neonates in the rooming-in cohort was significantly lower than those admitted
directly to the NICU” (p. 558). In addition, a further study conducted by Holmes et al (2016) at
the Children’s Hospital at Dartmouth-Hitchcock (CHaD) using rooming-in argued how the
hospital was able to “reduce the rate of pharmacotherapy for NAS to 27 percent” (p. 1).
Moreover, a study conducted by Bagley et al (2014) revealed “non-pharmacologic interventions
may provide some benefit for infants with NAS by decreasing clinical symptoms and the need
for pharmacologic therapy” (p. 7). As such, breastfeeding and rooming-in can provide
opportunities for bonding and may normalize the postpartum process for women who feel
“stigmatized” as well.
That being said, with regard to moving forward - specific recommendations for
implementation in nursing practice is to continue to ensure that the newborn is eating an
appropriate amount based on their days of age. In other words, a baby that is either one or two
days old – this amount of volume may be less than an ounce per feeding. By contrast, for a baby
that is three days old or greater, this should at least be one or more ounces per feed. Also,
breastfeeding quality should be “good” as defined by the mother and nursing staff assessments.
In addition, the use the Model of Developmental Care that focuses on “protected sleep, pain and
stress assessment management, developmental activities of daily living, family centered care,
and the healing environment” (Coughlin et al., 2009, p. 2239) - should also be implemented. For
instance, the newborn should be able to sleep undisturbed for a minimum of one hour. Although
holding the newborn to support an undisturbed sleep period is recommended and often
necessary. Finally, it is important to determine whether the newborn can be consoled within ten
minutes. If not, non-pharmacologic interventions should be increased including a second
caregiver making attempts to console the newborn. If the newborn remains inconsolable, this
would be an indication that the newborn may need pharmacologic treatment and the medical
team should be notified (Graham et al., 2019).
By contrast, non-pharmacologic interventions include several other components. For
instance, low stimulation, decrease light and noise, soft music and minimal disturbances, which
include timed exams and procedures when the infant is awake and fed. Opportunities for non-
nutritive sucking are offered including nuzzling at mother’s breast during Kangaroo Care
sessions and sucking on a pacifier with nasogastric tube feedings. Swaddling the baby with
hands near their mouths and provide containment. Nurses educate family members to not wake a
sleeping baby. The baby can rest for 4-5 hours at a time (“NAS Mahoning Valley Campus”
2019).
Further, it is also the nurses responsibility to educate parents/legal guardians about how
the ESC model works as well as encourage them to be included in the care of their infant. For
instance, in effort to provide a low stimulation environment, babies at Akron Children’s Hospital
are placed in a private room for comfort. Once the rooms are identified and the family is
comfortable a three-step implementation process occurs simultaneously: identification of a point
of contact, development of a core NAS work group, and finding a community outreach program
(Graham et al., 2019). Aspects of the ESC method rely on a multidisciplinary team. Finding a
point of contact would be a person where a mother can easily seek information on NAS and be
assisted in navigating prenatal care system. Currently, at Akron Children’s Hospital, a social
worker is typically the point of contact and is responsible for educating parents on what is
expected post delivery when using the ESC method. Developing a core NAS workgroup is an
important aspect of the ESC method. Nurses are trained regularly on how to use the method and
how to early identify NAS symptoms and when to start the ESC approach. After discharge, the
family is set up with a community outreach program to help assist care for their infants including
home nursing visits, Help Me Grow referral, a follow up appointment with pediatrician in one
week and being evaluated by the Infant Therapy Team (“NAS Mahoning Valley Campus,”
2019).
The ESC approach is a fairly new method that reduces the amount of medications needed
for NAS infants, lessens the length of stay in the NICU and SCN, and decreases healthcare cost.
To determine the outcomes of success of implementing the ESC would be based upon the
infant’s temperament, need for pharmacological use, length of stay, readmission rates, and
reduction in postnatal use of opioids. According to the study completed by Wachman et al

(2018), using the ESC approach pharmacological treatment “decreased from 87.1% to 40%,
adjunctive agent used from 33.6% to 2.4%, hospitalization length from a mean 17.4 to 11.3 days,
and opioid treatment days from 16.2 to 12.7. Total hospital charges decreased from $31,825 to
$20,668 per infant. Parental presence increased from 55.6 to 75.8%” (p. 1120). Information
collected from these studies could change the standard of care and practices for NAS infants and
their families and currently has changed the practice of care at Akron Children’s Hospital.
Overall, there were several areas identified that would benefit from additional research
including the effects of growth and development, the ESC model, prenatal education, and
breastfeeding; however, for the purpose of this topic - the focus of additional research will be on
ESC, breastfeeding, and prenatal education. Generally speaking, education is one of the key
elements of patient care within the healthcare system; however, missed opportunities to improve
a patient’s medical condition often occur for a number of reasons including restricted time with
patients and lack of trust between a patient and their provider. Unfortunately, with addiction and
recovery, the patient may feel embarrassment and shame. In addition, adding a pregnancy to the
recovery process may further increase anxiety. As such, obstetric care providers have a unique
opportunity to make a substantive impact on the lives of opioid dependent (OD) women and their
children by “providing a medical home for patients during pregnancy, facilitating care
coordination among providers and delivering comprehensive prenatal and postpartum care”
(Krans et al., 2015, p. 370).
Further, opioid dependency is not the only concern for mothers who are seeking
recovery. In other words, psychiatric disorders, tobacco use, social stressors, and infectious
diseases can also contribute to the patients care plan. Therefore, OD pregnant women should
receive “all elements of routine pregnancy care, but may benefit from more frequent prenatal
care visits to address complex psychosocial needs as well as facilitate referrals to social services
and case management to address long term needs after delivery” (Krans et al., 2015, p. 371). One
benefit of providing prenatal care is to have the ability to troubleshoot with the mother on signs
and symptoms of Neonatal Abstinence Syndrome (NAS). Having the opportunity of being
mentally prepared for the potential of the newborn experiencing NAS, can decrease the anxiety a
mother may experience after delivery. Additional research would be effective to determine if the
increase of prenatal care, with a multidisciplinary health team, decreases the length of stay and
improves the Finnegan score regarding eat, sleep, and consoling.
On the other hand, breastfeeding has been scientifically proven to be beneficial to both
the mother and newborn. With regard to a newborn with a diagnosis of NAS, according to a
study conducted by O’Connor et al (2013) “preliminary results suggest that breastfeeding may
reduce the severity of NAS as well as the likelihood of requiring pharmacologic treatment for
NAS” (p. 387). Also, according to Welle-Strand et al (2013) “breastfed neonates exposed to
methadone prenatally had significantly lower incidence of NAS requiring pharmacotherapy
(53% vs. 80%)” (p. 1060). However, the technique of breastfeeding can be stressful to a new
mother. One reason for this is because a mother needs to be disciplined, cautious of food intake,
and mindful of adequate rest. Placing those demands on a mother in recovery can be challenging
and possibly compromise her sobriety.
Interestingly, the American Academy of Pediatrics and American Academy of Family
Physician recommends “exclusive breastfeeding during the first six months of life and for an
additional one year with the incorporation of solid foods unless these are contraindications such
as maternal human immunodeficiency virus (HIV), chemotherapy, radiation therapy, and illicit
drug/polydrug abuse” (Eidelman, 2012). A decreased goal of three months for mothers who are
OD may be more realistic. Setting short term goals are more likely to be successful and decrease
the mother’s anxiety of not completing the recommended time set by the American Academy of
Pediatrics and American Academy of Family Physician. The goal is what is best for mother and
baby. Compared to formula fed infants, infants fed breastmilk are less likely to need
pharmacologic treatment for NAS and if treatment is required, require lower doses of morphine
and thus have shorter hospital lengths of stay. Breastfeeding is also associated with “stress
reduction, increased maternal confidence and enhanced mother-infant bonding” (Krans et al.,
2015, p. 375). Therefore, with a decreased stress level in the mother, this allows for better
feeding and consoling becomes less problematic in the process. Fortunately at Akron Children’s
Hospital, women are offered resources where they can discuss breastfeeding with a lactation
consultant and feel empowered. Based on the literature, “hospital practices should provide
breastfeeding education and support as part of early interventions for NAS” (Wu & Carre, 2018,
p. 8).
Overall, with the alarming rate of opioid abuse and increasing number of NAS babies, it
is evident that it places a significant burden on the healthcare system and neonate. As argued by
Patrick et al (2012) “the increasing incidence of NAS and its related health care expenditures call
for increased public health measures to reduce antenatal exposure to opiates across the United
States” (p. 1940). Even though the ESC model is relatively new model compared to the Finnegan
scale, the literature appears to be quite promising. According to Wachman et al (2018),
implementing non-pharmacologic care resulted in a decrease need for pharmacologic treatment
and led to subsequent shorter hospitalizations as well as resulted in significant cost savings. In
addition, the feedback from the neonatologist, nurse practitioners, nurses, and nurse educators at
Akron Children’s Hospital Mahoning Valley NICU/SCN were positive. As such, moving
forward, it would be beneficial to conduct a research study at the campus and then potentially
present the results at a Unit-Based-Council (UBC) meeting in effort to have the ESC
implemented across all campuses. By doing so, this could lead to standardized care, reduce
length of stay and pharmacological measures, improve staff ratios, and improve compliance
issues with the Ohio Department of Health (ODH) audits.

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Patrick, S.W., Schumacher, R.E., Benneyworth, B.D., Krans, E.E., Mcallister, J.M., & Davis, M.
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prevention/prescription-drugs/educating-families-about-nas-weise-and-scull.pdf
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Quality improvement initiative to improve inpatient outcomes for Neonatal Abstinence
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Welle-Strand, G. K., Skurtveit, S., Jansson, L. M., Bakstad, B., Bjarko, L., & Ravndal, E. (2013).
Breastfeeding reduces the need for withdrawal treatment in opioid-exposed infants. Acta
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Wu, D., & Carre, C. (2018). The impact of Breastfeeding on Health Outcomes for
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Journal of Medical Science, 10(7), 1–10.

Appendix
ARTICLE CITATION
Bagley, S.M., Wachman, E.M., Holland, E., & Brogly, S.B. (2014). Review of the assessment and management of
neonatal abstinence syndrome. Addiction Science & Clinical Practice, 9(19), 1-10. doi: 10.1186/1940- 0640-9-19
PURPOSE/
HYPOTHESIS The objective of this review was to “summarize available evidence on the assessment and
management of infants exposed to opioids in utero, including assessment tools used for NAS
scoring, nonpharmacologic interventions, and pharmacologic management of NAS” (p. 2).
This was achieved through conducting a systematic review.
CONCEPTUAL A conceptual framework was not utilized.

FRAMEWORK
SAMPLE/ SETTING A systematic search was conducted using PubMed and the Cochrane Database. This search
focused on three main keywords including (1) assessment of NAS, (2) nonpharmacologic
interventions for NAS, and (3) pharmacologic treatment of NAS (2014). Overall, the articles
examined were published between 1975 and November 15, 2013.
In total:
- With regard to assessment, of 368 articles reviewed - eight pertained to the evaluation
of assessment tools for NAS.
- With regard to nonpharmacologic interventions, of the 879 reviewed - 13 were
included.
- With regard to pharmacologic interventions, of the 940 articles reviewed - only seven
met the inclusion criteria.
VARIABLES The variables studied consisted of reviewing a number of studies ranging from cohort to
STUDIED randomized controlled trials using keywords that focused on the assessment of NAS as well as
nonpharmacologic and pharmacologic treatments for NAS.
DESIGN Systematic Review
THREATS TO Overall “different inclusion criteria were applied for the three study categories due to varying
INTERNAL & availability of data and types of studies conducted in each area” (p. 2). For instance “criteria
EXTERNAL for permitting breastfeeding were not described in every study, which introduced [a] bias” (p.
VALIDITY 4). Further, with regard to assessment studies some “were eliminated due to clinical issues.
For example, one excluded study used infant sucking as the study outcome of NAS
improvement” (p. 2).
MEASUREMENT Different inclusion criteria were used for the three study categories due to varying availability
of data as well as types of studies conducted in each area (2014).
For nonpharmacologic treatment:

- Studies composed of cohort, case series, case–control, and randomized controlled
trials (RCTs).
For pharmacologic treatment:
- Only RCTs and nonrandomized experimental studies were included.
For nonpharmacologic intervention and pharmacologic treatment studies:
- Articles were only included if they defined objective NAS outcome measures
DATA ANALYSIS PubMed and the Cochrane Database were used to search the references in the identified
articles.
FINDINGS/
RESULTS Nonpharmacologic Interventions:
- “Breastfeeding is recommended in stable mothers on methadone and buprenorphine

maintenance therapy who are not concurrently using illicit drugs” (p. 3). In general, it
is argued that the transfer of methadone and buprenorphine into breast milk is
“minimal.” Further, breastfeeding has been shown to “act as an analgesic for infants
and is established as beneficial for soothing agitated infants” (p. 3). Overall, the
primary findings suggested a “decreased need for pharmacologic treatment, a decrease
in NAS scores, and decreased length of pharmacologic therapy and hospitalization for
infants who were breastfed primarily or breastfed to any extent” (p. 3). Other
interventions suggested included rooming-in, bed-type, and positioning of the infant.
Pharmacologic Interventions:
- Efficacy of opioid vs. phenobarbitone as first-line therapy - 8 vs. 12 days

- Compare tincture of opium to oral morphine - 29.8 vs. 26.9 days
CRITIQUE Overall, the study suggested that there is limited evidence in regards to pharmacologic and
non-pharmacologic interventions. For instance, since there is currently no FDA-approved
medications for NAS “there is a need for high-quality RCTs to determine best practices and to
establish safety and efficacy” (p. 8). In addition, with regard to breastfeeding, it mentions the
evidence is beneficial; however, more studies and a randomized controlled design are needed.
As such, it is understandable for why it is recommended for nurseries to adopt a standard
protocol in effort to improve quality of care. That being said, as the study suggests “further
research is urgently needed to assure the best care for infants with NAS” (p. 10).
REPLICATION
“Further studies should focus on how to increase the rates of breastfeeding and rooming-in”
(p. 8). In general, the evidence so far is currently limited; however the results show signs of
being beneficial and a randomized controlled design would be helpful in further supporting
this argument. In addition “although preliminary, the use of buprenorphine to treat NAS
shows promise, further research should be done that includes feasibility testing because
administering it sublingually might present some administrative challenges” (p. 8).
LEVEL OF Level I
RESEARCH/
EVIDENCE
C. There was no theory used in the study.
D. With regard to the PICO question - the literature highlighted the Finnegan scale, NAS babies, pharmacologic use, and length of
stay. Even though the Eat, Sleep, and Console (ESC) model was not specifically mentioned - nonpharmacologic interventions such as
rooming-in were argued to be beneficial. That being said, as the incidence and clinical impact of NAS rises, “it is critical that
clinicians employ a common, objective, and validated tool to guide diagnosis and treatment of NAS” (p. 7). According to the
American Academy of Pediatrics (APP) - a standardized tool such as the gold- standard Finnegan abstinence assessment evaluation
should be utilized. Either way, as the researchers argued “creating a more secure, compassionate, and comfortable environment for
the dyad will likely optimize outcomes for both mother and infant” (p. 8).
ARTICLE CITATION
Coyle, M.G., Ferguson, A., Lagasse, L., Oh, W., & Lester, B. (2002). Diluted tincture of opium (DTO) and
phenobarbital versus DTO alone for neonatal opiate withdrawal in term infants. The Journal of Pediatrics, 140(5), 561–
564. doi.org/10.1067/mpd.2002.123099
PURPOSE/
HYPOTHESIS The aim of the study was to “test the hypothesis that treatment of neonatal opiate withdrawal
(NOW) in the term infant with diluted tincture of opium (DTO) and phenobarbital was
superior to treatment with DTO alone” (p. 561).

FRAMEWORK
SAMPLE/ SETTING A total of 20 term infants exposed to methadone and/or heroin in utero were studied. Overall,
the severity of the withdrawal symptoms were based on the Finnegan scoring system.
1) DTO and placebo (n = 10)

2) DTO and phenobarbital (n = 10) when medication was required.
VARIABLES The primary outcome variable was the length of stay. In addition, severity of withdrawal and
STUDIED hospital cost were considered to be secondary outcome variables.
DESIGN Partially randomized, controlled trial
THREATS TO Overall, there were a number of limitations noted in the study. For one, the preterm infant
INTERNAL & experiences less severe withdrawal symptoms compared with the term infant. Therefore, only
EXTERNAL term infants were the subjects of this report (2002). In addition, considering the report was a
VALIDITY small study - it did not address the long-term outcome for these infants.
MEASUREMENT Two measures were employed to determine the severity of withdrawal:

“1) The infants receiving DTO alone spent a significantly
greater period with a score >7 (P < .04), and the infants
receiving DTO and phenobarbital spent a significantly
greater period of time with scores <5 (P < .03).
2) The second measure of withdrawal severity was the

maximum daily dose of DTO required to treat symptomatic
withdrawal. The infants who received DTO only required a
maximum daily DTO dose of 16.8 mL ± 3.7 mL versus 4.7
mL ± 2.7 mL for the infants receiving DTO and
phenobarbital (P < .009)” (p. 563).
DATA ANALYSIS “Two-tailed Student t tests were used to determine differences between the groups, and when
appropriate, the Pearson correla- tion coefficient was used. The Mann- Whitney U test was
used to compare median values between groups” (p. 562).
FINDINGS/ “The combination of DTO and phenobarbital resulted in a shorter LOS, less severe
RESULTS withdrawal, and reduced hospital cost” (p. 561). As such, it was argued that this may be a
preferred regimen for the treatment of NAS.
CRITIQUE Overall “the use of DTO and phenobarbital for the treatment of NOW compared with DTO
alone lessens the severity of withdrawal, shortens hospitalization, and reduces hospital cost”
(564). However, considering these medications are powerful and could be potent, larger
clinical trials need to be conducted.
REPLICATION
Another clinical trial utilizing a larger group could be conducted that focuses on long-term
outcomes.
LEVEL OF Level II
RESEARCH/
EVIDENCE
D. With regard to the PICO question - NAS babies and the Finnegan scale were explored; however, the Eat, Sleep, and Console (ESC)
model was not mentioned. In addition, this study was too small and did not address the long-term outcome for NAS babies. Therefore,
recommendations for the preterm infant cannot be made based on our findings.
ARTICLE CITATION
Disher, T., Gullickson, C., Singh, B., Cameron, C., Boulos, L., Beaubien, L., Campbell-Yeo, M. (2019).
Pharmacological Treatments for Neonatal Abstinence Syndrome: A Systematic Review and Network Meta-analysis.
JAMA Pediatrics, 173(3), 234-243. doi: 10.1001/jamapediatrics.2018.5044
PURPOSE/
HYPOTHESIS The aim of this study was to “compare pharmacological therapies for neonatal abstinence
syndrome” (p. 234).
CONCEPTUAL This study utilizes a conceptual framework.

FRAMEWORK
SAMPLE/ SETTING Neonates who were exposed to opioids in utero who required pharmacological treatment for
symptoms of NAS.
VARIABLES Length of stay, need for adjuvant therapy, and adverse events with the use of clonidine,
STUDIED morphine, methadone, phenobarbital, buprenorphine.
DESIGN Systematic review with a Bayesian network meta-analysis
THREATS TO This study used direct and indirect evidence from RCT, which causes threats to validity. Also,
INTERNAL & this study does not include neonatal age, type of illicit drug use by mother, what scoring
EXTERNAL methods were used including FNASS/ESC approach. The uses of non-pharmacological
VALIDITY interventions were poorly reported. Minimal studies were reviewed to produce the
information.
MEASUREMENT For length of treatment 8 out of 10 studies were reviewed. Fixed effects model was used.
Length of stay was assessed by reviewing 6 studies and measured by a fixed effect model.
“Threshold plots indicated that the analysis was robust to feasible adjustments for risk of bias,
but sensitive to imprecision in the estimates of treatment effects” (p. 239). Next, seven studies
were studied for the need for adjuvant. Three were excluded from analysis for being
conducted prior to 2000. Two studies could not be connected due to the network. No
connected network could be formed with adverse events.
DATA ANALYSIS The network meta-analysis was conducted using JAGs. At least 1 comparison contained 2
treatments, the applicability of random effects models was explored. “A sensitivity analysis
was performed to assess the implications of the risk of bias and uncertainty using threshold
plots outlined by Phillippo et al.” (p. 239). In addition, “convergence was monitored using the
Brooks-Gelman-Rubin diagnostic with values less than 1.05 considered acceptable. Treatment
rankings were summarized using the median rank with its 95% credible interval” (p. 239).
FINDINGS/ “In this meta-analysis study, buprenorphine was associated with the shortest length of
RESULTS treatment without additional adverse events. Morphine was consistently among the least
effective treatments” (p. 240).
CRITIQUE This study reviews RCT on the effectiveness of different types of medications that improve
NAS symptoms. Efforts should be made to identify and eliminate differences in treatment
protocols that may explain differences in length of stay. Many of the studies were rejected due
to being completed prior to 2000, leaving little information on the subject that was being
reviewed.
REPLICATION
“It is unlikely that the current evidence base is sufficient to recommend specific, large scaled
changes in treatment in any way from the current standard of care” (p. 241). As such, there
needs to be an ongoing clinical trial with a large, multisite that will allow for an “estimation of
the effectiveness of buprenorphine versus morphine and identify the magnitude and causes
between site heterogeneity” (p. 241).
LEVEL OF Level I
RESEARCH/
EVIDENCE
C. There were multiple theories used in this research article. Many of the prior theories did not produce the same results as this meta-
analysis review. The researchers of this study reviewed the previous theories completed.
D. The literature did not prove enough credible research evidence to answer our group's PICO question. It reviewed lengths of stay,
and pharmacological treatment, however, did not review the ESC method nor look at non-pharmacological interventions.
ARTICLE CITATION
Grossman, M.R., Berkwitt, A.K., Osborn, R.R., Xu, Y., Esserman, D.A., Shapiro, E.D., & Bizzarro, M.J. (2017). An
Initiative to Improve the Quality of Care of Infants With Neonatal Abstinence Syndrome. Pediatrics, 139(6). doi:
10.1542/peds.2016-3360
PURPOSE/
HYPOTHESIS At Yale New Haven Children’s Hospital (YNHCH), the incidence of neonatal abstinence
syndrome (NAS) has increased dramatically along with a number of disturbances associated
with opioid withdrawal hospital stays. As such, the “researchers aimed to reduce ALOS for
infants with NAS by 50%” (p. 1).
CONCEPTUAL Holmes et al (rooming-in) and Asti et al (weaning protocol) were utilized to reduce ALOS and
FRAMEWORK help guide pharmacologic management of NAS.
SAMPLE/ SETTING There were 287 methadone exposed infants used in the research at Yale New Haven
Children’s Hospital.
VARIABLES A comparison between the use of the Finnegan scale and the ESC model in NAS babies and
STUDIED their influence on average length of stay, the proportion of infants treated with morphine, and
hospital costs.
DESIGN Quality Improvement
THREATS TO Implementation evolved over a 5-year period. Several of the interventions involved changes in
INTERNAL & the culture of how infants with NAS were managed. Also, during implementation of the
EXTERNAL intervention bundle, there were changes in both staffing models and hospital policies that may
VALIDITY have affected the results.
MEASUREMENT “Primary outcome measure was ALOS, calculated from date of birth, measured as day of life
0, until date of discharge. Secondary measures included the proportion of infants treated with
morphine and the average total cost of hospitalization, including direct and indirect costs” (p.
4).
DATA ANALYSIS Overall, statistical process control (SPC) charts were used to evaluate the impact of the
interventions, which were developed by using Microsoft Excel QIMacros. Also, “p values (2-
tailed) are reported from pairwise t tests for continuous variables and from either χ2 tests or
Fisher’s exact tests for categorical variables” (p. 3).
FINDINGS/ The use of morphine and the average cost of hospitalization were substantially reduced. For
RESULTS instance “after the implementation of these interventions, the use of morphine to treat NAS
decreased to 14%” (p. 5).
CRITIQUE Although the results were promising, the ESC model is a new intervention, which would thus
require a change in an organization’s culture and could take time to implement. Furthermore,
there is not enough long-term studies to justify its outcome.
REPLICATION
Additional studies that assess effects on growth, development, and behavioral outcomes are
needed and could be conducted.
LEVEL OF Level IV
RESEARCH/
EVIDENCE
C. Grossman and colleagues set out to “reduce ALOS for infants with NAS by 50%” (p. 1). In effort to achieve this goal, they utilized
Holmes et al rooming-in model as well as Asti et al stringent weaning protocol. Overall “by changing the paradigm of how infants
with NAS are treated and evaluated, we reduced our ALOS to 5.9 days. The potential savings in hospital costs from this approach is
considerable” (p. 2). As such, research has supported their interventions.
D. With regard to the PICO question - the Eat, Sleep, and Console (ESC) model, Finnegan scale, and length of stay were all
addressed. Although this model is new, based on the evidence presented “supportive, nonpharmacologic interventions combined with
assessments that focused on the functional well-being of infants with NAS, rather than on FNASS scores, dramatically and sustainably
reduced ALOS” (p. 7). Further, it also resulted in a decreased use of morphine.
ARTICLE CITATION
Grossman, M.R., Lipshaw, M.J., Osborn, R.R., & Berkwitt, A.K. (2018). A Novel Approach to Assessing Infants With
Neonatal Abstinence Syndrome. Hospital Pediatrics, 8(1). doi: https://doi.org/10.1542/hpeds.2017-0128
PURPOSE/ The aim of the study was to describe the ESC approach and compare it to a more traditional
HYPOTHESIS FNASS-driven approach.
CONCEPTUAL A conceptual framework was utilized.

FRAMEWORK
SAMPLE/ SETTING “The study population included all infants born at or greater than 35 weeks gestation at Yale
New Haven Children’s Hospital with prenatal exposure to opioids from March 2014 to
August 2015 who were managed on a general inpatient unit and NICU” (p. 3).
VARIABLES A comparison between FNASS and ESC methods and their effects on weight loss, feeding
STUDIED ability, length of stay, and opioid usage.
DESIGN Retrospective cohort study
THREATS TO This study had several threats to internal and external validity. One limitation was that there
INTERNAL & was no random selection when choosing patients, such as one group for FNASS and another
EXTERNAL group for ESC. The infants were also treated by four pediatricians and multiple registered
VALIDITY nurses allowing variation in the treatment approach. The FNASS scores were also recorded by
a large number of nurses, and no documentation of interrater reliability was completed.
MEASUREMENT The primary outcome measurement assessed was the “proportion of patients started on
morphine therapy by using the ESC approach compared with the predicted proportion of
patients who would have been started on morphine by using the FNASS approach” (p. 6).
Also, a secondary outcome was the

“proportion of days that each approach recommended a specific pharmacologic management.
Researchers also assessed the number of incidences when the ESC approach and the FNASS
approach differed in their recommendations for morphine therapy” (p. 6).
DATA ANALYSIS “Microsoft excel was used for statistical analysis. Categorical variables were analyzed by
using Fischer’s exact test as appropriate. Continuous variables were analyzed by using t tests”
(p. 4).
FINDINGS/ By using the ESC approach “6 infants (12%) were treated with morphine compared with 31
RESULTS infants (62%) predicted to be treated with morphine by using the FNASS approach. The ESC
approach started or increased morphine on 8 days compared with 76 days predicted by using
the FNASS approach. There were no readmissions or adverse events reported” (p. 1).
CRITIQUE The study presented a representation between the ESC approach and FNASS approach by
using a conceptual framework. Overall, few limitations occurred, however, did not take into
account possible readmission rates at other hospitals.
REPLICATION Additional studies are needed to “assess the long-term neurodevelopment outcomes associated
with various evaluation and treatment approaches” (p. 6).
LEVEL OF Level II
RESEARCH/
EVIDENCE
C. This study has been based upon previous theories set by Holmes et al. Holmes et al., continued to use the FNASS but no longer
used the strict scoring parameters instead prioritized feeding difficulties, weight gain, difficulty sleeping and inconsolability. This
project “demonstrated a decrease in opioid exposed infants treated with morphine from 46% to 27% and a reduction in ALOS from
16.9 to 12.3 days. The current study proved that the ESC approach was used as a part of a 5 year quality improvement project that led
to a decrease in pharmacological treated infants from 98% to 12% and a decrease in ALOS from 22.5 to 5.9 days” (p.5).
D. The literature provided enough information to answer the PICO question. The study reviewed length of stay in the hospital setting,
ESC method versus FNASS method results, and the amount of opioid usage.
ARTICLE CITATION
Hall, E.S., Isemann, B.T., Wexelblatt, S.L., Derr, J.M., Wiles, J.R., Harvey, S., & Akinbi, H.T. (2016). A Cohort
Comparison of Buprenorphine versus Methadone Treatment for Neonatal Abstinence Syndrome. The Journal Of
Pediatrics. Retrieved from https://www.jpeds.com/article/S0022-3476(15)01451-1/pdf
PURPOSE/
HYPOTHESIS “To compare the duration of opioid treatment and length of stay among infants treated for
neonatal abstinence syndrome (NAS) by using a pilot buprenorphine vs conventional
methadone treatment protocol” (p. 39).
CONCEPTUAL Kraft et al. (2008) initial loading dose was utilized.

FRAMEWORK
SAMPLE/ SETTING 354 Neonates treated pharmacologically for NAS with methadone or buprenorphine in
Southwest Ohio from January 2012 through August 2014. A standardized methadone protocol
was used across all 6 hospitals/nurseries - located at Bethesda North Hospital, Cincinnati
Children’s Hospital Medical Center, Good Samaritan Hospital, Mercy Health – Anderson
Hospital, Mercy Health – Fairfield Hospital, and the University of Cincinnati Medical Center.
VARIABLES Infants were categorized in 1 of 2 mutually exclusive opioid exposure groups: short-acting
STUDIED opioids only or buprenorphine with or without short-acting opioids (but no methadone).
DESIGN Retrospective cohort analysis

THREATS TO Threats to internal and external validity in this study include that “[the study] was limited by
INTERNAL & the reliance on self-reported maternal drug use history and maternal and/or infant drug testing
EXTERNAL to determine opioid exposures; the full extent of exposures may not have been captured.
Toxicology testing of umbilical cord tissue, meconium, and urine vary in their sensitivity and
VALIDITY
some fetal exposures may have been undetected (false negative)” (p. 43).
MEASUREMENT The primary outcome measure was duration of opioid therapy and length of inpatient hospital
stay among infants treated pharmacologically for NAS. Nonetheless, they hypothesized that
pharmacotherapy with buprenorphine would shorten treatment courses. They also examined
the use of adjunct therapy with phenobarbital as a secondary outcome.
DATA ANALYSIS They compared the characteristics of “infants treated with buprenorphine to those who
received methadone by using chi-square tests for categorical variables and t tests for
continuous variables” (p. 41).
“To better understand the independent relationship between treatment protocol

(buprenorphine vs methadone) and the primary outcomes, linear mixed models were
constructed to control for potential confounding factors” (p. 41).
“Random effects were used to account for clustering within each nursery; however, the study
was not powered to detect differences in primary outcomes among the 6 nurseries” (p. 41).
“Sub analyses were performed for short-acting opioid and buprenorphine exposure groups. As
a secondary analysis, a x2 test was used to identify differences in the use of adjunct therapy
between treatment groups” (p. 41).
“Lastly, t tests were used to detect differences in the unadjusted duration of opioid treatment
and length of stay outcomes between opioid exposure categories within each treatment group”
(p. 41).
“All statistical analyses were performed using SAS version 9.3 (SAS Institute Inc, Cary,
North Carolina) software” (p. 41).
FINDINGS/ In the current study, “analysis demonstrated shorter duration of opioid treatment and briefer
RESULTS length of inpatient stay for infants that received sublingual buprenorphine compared with
conventional oral methadone pharmacotherapy for NAS” (p. 42). Also, “weaning with an
agent from the same drug class as the offending substance is recommended for mitigating
withdrawal symptoms in infants exposed to opioids in utero” (p. 42).
CRITIQUE “Although several previous analyses have described effects of buprenorphine for maternal
medication-assisted therapy on infant outcomes and this study represents the largest analysis
to date of sublingual buprenorphine for NAS treatment outside of a research context.
Nonetheless, there are still very few studies that have compared the relative utility of the
different protocols and the medications used in treating infants with NAS” (p. 42).
REPLICATION
This study focused only on infants with withdrawal severity needing pharmacologic treatment
with a first-line opioid. They did not measure the number of opioid-exposed infants managed
with non pharmacologic care, nor did they measure differences in the percentage of infants
requiring pharmacologic treatment with opioids related to various exposure categories.
“Future work including a randomized control trial at additional sites is needed to strengthen
the conclusions reached in this analysis, which are limited by the modest size of the study
cohort and the implementation of buprenorphine treatment at a single site” (p. 43).
LEVEL OF Level IV
RESEARCH/
EVIDENCE
C. Hall and the other researchers’ goal were to compare the duration of opioid treatment and length of stay among infants treated for
neonatal abstinence syndrome (NAS). In order to achieve this goal, they utilized Kraft et al. initial loading dose protocol. Inclusive, by
using this protocol, they were able to “shorten duration of opioid treatment and briefer length of inpatient stay for infants that received
sublingual buprenorphine compared with conventional oral methadone pharmacotherapy for NAS” (p. 42).
D. With regard to the PICO question - NAS babies, pharmacologic use, and length of stay were all explored. The Eat, Sleep, and
Console (ESC) model and the Finnegan score were not specifically mentioned. Therefore, this study did not answer our PICO
question. Interestingly enough, the researchers developed their own buprenorphine-weaning protocol for NAS treatment and training
was administered at all participating nurseries for standardization of NAS assessment, including scoring and initiation of
pharmacologic treatment before the study period. This study represents the largest analysis to date of sublingual buprenorphine for
NAS treatment outside of a research context. Nonetheless, more studies are needed in regards to this being a new protocol.
ARTICLE CITATION
Hendree, J., Seashore, C., Johnson, E., Horton, E., O’Grady, K., Andringa, K., Grossman, M., Whalen, B., & Holmes,
A. (2016). Brief Report: Psychometric Assessment of the Neonatal Abstinence Scoring System and the MOTHER NAS
Scale. American Journal on Addictions, 25(5), 370-373. doi: 10.1111/ajad.12388
PURPOSE/ This study examines the psychometric characteristics of the Neonatal Abstinence Scoring
HYPOTHESIS System and the Mother NAS scale. The study answers two questions: what are the
psychometric properties of the NASS and the MN, and is one measure superior in terms of its
psychometric properties? (2016).

FRAMEWORK
SAMPLE/ SETTING 131 opioid dependent pregnant women with a singleton fetus between 6 and 30 weeks
gestation who were seen at seven different university hospitals combined into three categories
—US Urban, US Rural, and European.
VARIABLES Variables studied included the first assessment of NASS, peak NAS score MNS, Treatment
STUDIED initiation NASS. Other factors include site, pharmacotherapy condition and neonatal gender.
DESIGN Randomized control trial
THREATS TO Threats to internal and external validity include considerable clinical interpretation of neonatal
INTERNAL & behavior, even with extensive training of raters. “Both instruments were developed using what
EXTERNAL has been termed a rational approach to scale construction, so an empirical procedure was not
used for scale development. The scoring was based on a rational weighting scheme that was
VALIDITY
not empirically tested” (p. 373). In addition, drawbacks, ambiguity, floor or ceiling effects, or
lack of discrimination were threats. Also “raters focused on other clinical signs including
sneezing, yawning or tremors and neglected or underemphasized clinical relevant symptoms
such as weight loss, or poor weight gain, feeding difficulty, sleeping or inability to be
consoled” (p. 373).
MEASUREMENT Measurement of NAS consisted of “31 signs of central nervous, gastrointestinal or respiratory
disturbances that are scored either zero or variously one through five, indicating presence
and/or degree of severity, with a score range of 0-46, inclusive” (p. 371). Generally speaking,
the MNS includes “all NAS items, but uses a revised scoring procedure in an attempt to
incorporate the number of modifications and improvements. It does not score 14 NASS items
due to their overlap with other items. MNS total scores are based on 19 weighted item scores,
and can range from 0-42, inclusive” (p. 371).
DATA ANALYSIS Scores on all NASS and MNS items for each participant were recorded in the study database.
Obtaining NASS scores after completion of the MOTHER study was possible. Corrected
item-total correlations and internal consistency reliabilities (Cronbach’s a), were calculated
for each measure, controlling pharmacotherapy condition, site, neonatal gender.
FINDINGS/ Both the NASS and MNS demonstrated poor psychometric properties with internal
RESULTS consistency (Cronbach’s as) failing to exceed .62 at first administration, peak NAS score and
NAS treatment initiation. Findings support the need for development of NAS measures based
on sound psychometric principles. “Two frequently used measures of neonatal abstinence
syndrome suffer inadequacies in regard to their basic measurement characteristics” (p. 371).
CRITIQUE The scoring systems devised for these instruments are subjective. Also, since determining the
psychometric properties of the NASS and MNS was the time at which NAS was addressed,
the first administration of the MNS and at the peak MNS score might represent
underestimates, floor and ceiling effects. MOTHER study and NAS study required
considerable clinical interpretation of neonatal behavior, even with extensive training of
raters.
REPLICATION
“The present study is limited by its use of secondary analyses of data collection as part of a
study whose primary aims did not focus on psychometric examination. A study whose focus
was to exam psychometric characteristics of the two measures could have reached different
conclusions” (p. 373).
LEVEL OF Level II
RESEARCH/
EVIDENCE
D. The literature did not provide enough research evidence to answer the PICO question because it did not evaluate the ESC method,
however, it did look at other scoring methods for NAS.
ARTICLE CITATION
Holmes, A.V., Atwood, E.C., Whalen, B., Beliveau, J., Jarvis, J.D., Matulis, J.C., Ralston, S.L. (2016). Rooming-in to
Treat Neonatal Abstinence Syndrome: Improved Family-Centered Care at Lower Cost. American Academy of
Pediatrics, 137(6), e1- e9. doi: https://doi.org/10.1542/peds.2015-2929
PURPOSE/
HYPOTHESIS The aim of this project was to “improve the care of opioid-exposed newborns by involving
families, standardizing assessment and treatment, and transitioning to rooming in for the full
hospital stay” (p. 2).

FRAMEWORK
SAMPLE/ SETTING This study was conducted at Children’s Hospital at Dartmouth-Hitchcock (CHaD). Overall,
the sample consisted of “all birth hospitalizations between March 2012 and February 2015
with reported or laboratory confirmed maternal opioid use” (p. 4)
VARIABLES Comparing the difference in length of stay and hospital costs when rooming-in with family is
STUDIED utilized.
THREATS TO During the beginning of the study, timing was

INTERNAL & changed during plan-do-study-act (PDSA) cycle 3. Also, infants were awakened from their
EXTERNAL sleep to obtain the Finnegan score and families indicated a lack of education on the signs and
VALIDITY symptoms of NAS. Further, another threat was that the project occurred in a children’s
hospital. As such “generalizability might be limited to children’s hospitals where labor and
delivery services are colocated” (p. 7). Lastly, the service area where the study was conducted
is located in a rural homogenous area and mothers are dominantly maintained on
buprenorphine as opposed to methadone. Therefore, the results can be skewed because the
“length of treatment can be shorter when mothers take prescribed buprenorphine” (p. 7).
MEASUREMENT “Outcomes of interest included concordance of paired scores by independent observers,

average daily score, percentage treated with oral morphine, percentage treated with an
adjunctive medication, cumulative morphine dose, LOS, and costs for all opioid-exposed
infants and for those treated pharmacologically” (p. 4). In addition, the researchers used κ
correlations for interrater reliability measures.
DATA ANALYSIS Overall, in effort to test for change in scoring across years - a mixed effects linear regression
model was used. Also, random effects were used to account for “variation within infant, and
first-order autoregressive variance covariance structure to account for time” (p. 4). In
addition, the researchers also “compared static categorical variables by Fisher exact test and
static continuous variables by independent t test” (p. 4). Further, the researchers also used “
analysis of means for categorical variables over time, and statistical process control (XmR)
charts for continuous variables over time” (p. 4).
FINDINGS/ “46% of inborn infants at-risk for NAS were treated with morphine; by 2015, this decreased to
RESULTS 27%. Adjunctive use of phenobarbital decreased from 13% to 2% in the same period. Average
LOS for morphine treated newborns decreased from 16.9 to 12.3 days, average hospital costs
per treated infant decreased from $19, 737 to $8,755, and costs per at-risk infant dropped from
$11, 000 to $5, 300. Cumulative morphine dose decreased from 13.7 to 6.6 mg per treated
newborn. There were no adverse events, and 30-day readmission rates remained stable” (p. 1).
CRITIQUE As mentioned above, the hospital was able to reduce the rate of pharmacotherapy for NAS to
27% (2016). In addition, the hospital was also able to reduce “system costs by more than half
by caring for infants with prenatal opioid exposure and NAS in a rooming-in model, safely
eliminating the use of critical care beds for this condition” (p. 8). Although these results
appear to be promising, there were a number of limitations mentioned as well including the
study not being conducted in a pediatric hospital, but within a community hospital that has a
pediatric unit. This is important to take into consideration because NICUs frequently “drive
children’s hospital revenue, so reducing admission and LOS could financially penalize some
health systems” (p. 6).
REPLICATION There is a potential for replication to be completed within various community hospitals that
have pediatric units such as the unit used in the study.
LEVEL OF Level VI
RESEARCH/
EVIDENCE
D. With regard to the PICO question - the Finnegan scale, NAS babies, pharmacologic use, and length of stay were all explored. Even
though the Eat, Sleep, and Console (ESC) model was not specifically mentioned - nonpharmacologic interventions such as rooming-in
allowed for reduced rate of pharmacotherapy, reduced length of stay and reduced system costs. Overall, the research conducted in this
paper was beneficial in regards to providing evidence for our PICO question.
ARTICLE CITATION
Kraft, W.K., Adeniyi-Jones, S.C., Chervoneva, I., Greenspan, J.S., Abatemarco, D., Kaltenbach, K., & Ehrlich, M.E.
(2017). Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome. doi: 10.1056/NEJMoa1614835
PURPOSE/
HYPOTHESIS “Current pharmacologic treatment of the neonatal abstinence syndrome with morphine is
associated with a lengthy duration of therapy and hospitalization” (p. 2341). Therefore, the
aim of this study is to see if buprenorphine is more effective than morphine for this indication.
CONCEPTUAL This study does not utilize a conceptual framework.

FRAMEWORK
SAMPLE/ SETTING Randomly assigned, were 63 term infants (≥37 weeks of gestation) who had been exposed to
opioids in utero and who had signs of the neonatal abstinence syndrome. Randomization was
stratified according to the mother’s intended feeding pattern (bottle feeding vs. breast-feeding)
and maternal use of buprenorphine versus methadone.
VARIABLES A comparison between infants receiving buprenorphine or morphine, based on the sub groups
STUDIED of breastfeeding mothers vs bottle feeding mothers.
DESIGN Randomized Control Trials
THREATS TO - Small sample size, single-center design.

INTERNAL & - Exclusion of preterm infants and infants with in utero exposure to benzodiazepines.
EXTERNAL
VALIDITY
MEASUREMENT “The primary outcome measure was the duration of treatment for neonatal withdrawal
symptoms in days from the first dose of a trial drug. Secondary measures included clinical
length of hospital stay (including all levels of care), the percentage of infants who required
supplemental treatment with phenobarbital, and safety” (p. 2343).
DATA ANALYSIS - “Stratified two-sample van Elteren test was used to compare the duration of treatment and
the length of hospital stay in the two groups after adjustment for differences in the type of
feeding” (p. 2343).
- “A Cochran-Mantel-Haenszel test was used to evaluate the association between trial group
and the use of supplemental phenobarbital, stratified according to type of feeding” (p. 2344).
- “Longitudinal data were modeled in a linear mixed-effects model with the time trends
represented by low-order polynomials in postnatal days, with the polynomial coefficients
dependent on fixed effects of drug and feeding type and random effects of between-patient
variation” (p. 2344).
- “Statistical analyses were performed with the use of SAS software, version 9.4 (SAS
Institute), and R software (R Foundation for Statistical Computing)” (p. 2345).
FINDINGS/ Researchers found that “sublingually administered buprenorphine was significantly more
RESULTS effective than oral morphine in reducing the duration of treatment for the neonatal abstinence
syndrome, which translated into a shorter hospital stay” (p. 2348).
CRITIQUE Preterm infants and those with in utero exposure to benzodiazepines were excluded from the
study. “Exposure to benzodiazepines in utero is associated with worsened symptoms of
neonatal abstinence” (p. 2347). However, “buprenorphine has been used in critically ill
preterm infants, but its utility in preterm infants with the neonatal abstinence syndrome has
not been defined” (p. 2347). Furthermore, more studies should be done to find out the results
of the use of buprenorphine in infants with benzodiazepine exposure.
REPLICATION
“The frequency of adverse events was similar in the two groups. Infants in the morphine
group had a lower respiratory rate than those in the buprenorphine group. This potential
advantage, along with a longer interval between doses, may allow for additional studies where
investigation of buprenorphine in outpatient settings can be done, a use that was not examined
in this trial” (p. 2347).
LEVEL OF Level II
RESEARCH/
EVIDENCE
D. In regards to our PICO question, NAS babies, Finnegan score, pharmacological use and length of stay were identified. The eat,
sleep, and console method was not discussed, however sublingually administered buprenorphine reduced the duration of treatment
which shortened the length of hospital stay.
ARTICLE CITATION
Nayeri, F., Sheikh, M., Kalani, M., Niknafs, P., Shariat, M., Dalili, H., Dehpour, A. (2015). Phenobarbital versus
morphine in the management of neonatal abstinence syndrome, a randomized control trial. BMC Pediatrics, 15(57). doi:
10.1186/s12887-015-0377-9
PURPOSE/
HYPOTHESIS The primary purpose of the study was to “study the duration of pharmacologic treatment
needed for the resolution of symptoms of NAS” (p. 2).
CONCEPTUAL This study uses conceptual framework from a theory by Jackson et al. and Ebner et. al.
FRAMEWORK
SAMPLE/ SETTING “60 neonates who were born to illicit drugs dependent mothers and exhibited NAS requiring
medical therapy who were admitted at Vali-Asr and Akbar-Abadi teaching hospitals of the
Tehran University of Medical Sciences from August 2009 through February 2014” (p. 2).
VARIABLES Two groups were formed by oral Morphine Sulfate treated and the other group Phenobarbital
STUDIED treated group and the effects of treating NAS symptoms.
DESIGN Randomized, open-label, controlled trial
THREATS TO Threats to internal and external validity in this study include what type of dependence drug
INTERNAL & the mother is currently on; however, not all mothers in the study were purely taking opioids.
EXTERNAL Also, “research has shown that nicotine makes symptoms of NAS worse” (p. 7). The sample
VALIDITY size did not include if the mothers had used nicotine. Other factors not taken into
consideration were breast-feeding versus bottle-feeding.
MEASUREMENT “Sample size was calculated for a power of 80%, a+ 0.05, B=20% and a standard effect size of
0.84. Data were displayed using Mean, Standard deviation and Range. Mean comparisons
between two groups were performed using the T-test for independent variables. The Chi-
squared analysis, Fisher’s exact test, independent-samples t test, one way ANOVA were used
to examine the relationship between maternal drugs and demographic factors in both groups”
(p. 4).
DATA ANALYSIS All statistical analysis was performed using SPSS statistical software.
FINDINGS/ “The mean for the duration of therapy in the oral morphine group was 8 +/-5 days with a
RESULTS range of 2.8-21 days. The Phenobarbital group was 8.5 +/-4 days with a range of 4-21.2 days.
There was no significant difference in the duration of pharmacologic therapy required for
NAS resolution between Morphine Sulfate and Phenobarbital treated groups” (p. 5).
CRITIQUE Some of this research is generally biased due to not enough exclusion criteria for mothers to
truly test the efficiency of Morphine versus Phenobarbital.
REPLICATION This study could be replicated again, however, more studies with larger sample sizes are
needed to confirm that using Morphine Sulfate and Phenobarbital to treat NAS are both
effective.
LEVEL OF Level II
RESEARCH/
EVIDENCE
C. This study compared its results directly to research theories completed by Jackson et. al and Ebner et al. Both of these previous
theories suggested that Morphine Sulfate is the ultimate drug of choice for NAS treatment due to shorter duration of therapy. Several
factors could explain the differences observed in the results compared to the previous studies including in the study of Jackson et al.
and Ebner et al. due to blinding no loading of Phenobarbital was used, this could have introduced bias in favor of Morphine Sulfate. In
the studies completed by Jackson et al. and Ebner et al., the mothers only used opioids. All studies used different scoring tools on
when to medicate the neonates. The research completed by Nayeri et al. did not match previous theories.
D. The literature did not provide enough information to answer our group's PICO question. The information obtained in this study can
assist clinicians to treat NAS, however, does not review length of stay or the ESC method.
ARTICLE CITATION
Newman, A., Davies, G.A., Dow, K., Holmes, B., Macdonald, J., McKnight, S., & Newton, L. (2015). Rooming-in care
for infants of opioid-dependent mothers. The College of Family Physicians of Canada, 61(12), 555–561. Retrieved from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4677958/
PURPOSE/ The objective of the study was to “implement a rooming-in program to support close
HYPOTHESIS uninterrupted contact between opioid-dependent women and their infants in order to decrease
the severity of NAS scores, lessen the need for pharmacological interventions and shorten the
length of stay” (p. 555).
CONCEPTUAL Abrahams et al. (2010) rooming-in model was utilized.

FRAMEWORK
SAMPLE/ SETTING 21 mother-infant dyads were enrolled for the study.
VARIABLES The difference in the severity of NAS scores, the requirement for pharmacotherapy, and
STUDIED length of stay based on neonates being admitted to rooming-in and those admitted to the
NICU.
DESIGN Prospective Cohort Study
THREATS TO The sample size for the study was small with only 21 participants. During the beginning of the
INTERNAL & study, it was identified that further education needs to be completed by postpartum nursing
EXTERNAL staff for appropriate NAS scoring. In addition, newborns who were placed in child protective
VALIDITY services were unable to participate in the rooming-in with the birth mother. Further,
nonrandom selection may lead to biases.
MEASUREMENT The Finnegan scale was used to measure withdrawal symptoms. Data was collected and
statistical analysis was compared to previous admissions of mother/baby without the
intervention of rooming-in. The aspect of prenatal care with multidisciplinary medical
providers was also taken into consideration with the outcome.
DATA ANALYSIS A likert survey was utilized. In other words “women who participated in the rooming-in
program completed a survey after discharge” (p. 558). The survey consisted of a “5-point
scale (1=least satisfied, 5=most satisfied), 100% of women rated their overall experience as 4
or higher and 86% reported breastfeeding their infants for an average duration of 2.5 months”
(p. 558).
FINDINGS/ After rooming-in was implemented, this cohort study demonstrated a statistically significant
RESULTS decreased need for pharmacotherapy and hospital LOS (p. 559). Statistically speaking “the
requirement for oral morphine therapy for the neonates in the rooming-in cohort was
significantly lower than those admitted directly to the NICU” (p. 558). In other words, this
statistic went from “83.3% to 14.3%” (p. 558). Further, the LOS also decreased from “24.8 to
7.9 days” (p. 558).
CRITIQUE The study consisted of a small group of patients. In addition, considering the Finnegan scale is
subjective - potential biases may occur.
REPLICATION
With a limited number of subjects, it would be beneficial to have this studied replicated with a
larger group. Also, future research might focus on long term neonatal and childhood
outcomes, such as rates and duration of breastfeeding.
LEVEL OF Level IV
RESEARCH/
EVIDENCE
C. The 2010 publication of Abrahams and colleagues’ article, which focused on describing the use of rooming-in to manage opioid-
dependent infants is what guided the study as the hospital worked to introduce a similar model at their institution.
D. With regard to the PICO question - NAS babies, Finnegan score, pharmacological use, and length of stay were all identified.
However, the Eat, Sleep, and Console (ESC) model was not addressed in this research article. Nonetheless “length of stay and the
need for pharmacotherapy were dramatically reduced within the first year of implementation, and mothers rated their experience with
rooming-in favourably” (p. 560). As such, rooming-in would be highly recommended in order to maximize the success of ESC.
ARTICLE CITATION
O’Connor, A.B., Collett, A., Alto, W.A., & O’Brien, L.M. (2013). Breastfeeding rates and the relationship between
breastfeeding and neonatal abstinence syndrome in women maintained on buprenorphine during pregnancy. Journal of
Midwifery & Women’s Health, 58(4), 383– 388. doi:10.1111/jmwh.120 09
PURPOSE/
HYPOTHESIS The aim of the study is to determine if neonates receiving breast milk compared to formula
influences the length, intensity, and frequency of pharmacologic treatment.

FRAMEWORK
SAMPLE/ SETTING The participants in the study were “all infants born to opioid-dependent pregnant women
treated in the integrated buprenorphine program between December 2007 and August 2012”
(p. 383).
VARIABLES “Breastfeeding rates among opioid-dependent pregnant women maintained on buprenorphine

STUDIED in an integrated medical and behavioral health program [and] whether breastfeeding is related
to the duration, severity, and frequency of pharmacologic treatment for neonatal abstinence
syndrome (NAS)” (p. 383).
DESIGN Retrospective Cohort Study
THREATS TO A number of limitations exist in this study. For one, considering this study was a retrospective
INTERNAL & chart review “results can be used to generate potential hypotheses but cannot be used to
EXTERNAL establish cause and effect” (p. 386). In addition, the rationale for why women decided to
VALIDITY breastfeed and why some women initially did not, or why they stopped midway is not
revealed. Further “the small number of non-breastfed infants contributed to a larger than
expected standard error and limited the ability to establish statistical significance of the
observed differences in outcomes” (p. 386-387). Moreover, it is “not possible to distinguish

the potential impact of breastfeeding from many of the nonpharmacologic NAS therapies,
such as swaddling as well as skin-to-skin and other close contact with the mother, which may
occur in tandem with breastfeeding” (p. 386). Lastly, this study is nonrandomized and
uncontrolled.
MEASUREMENT Infants born to opioid-dependent women were observed for NAS in the hospital setting for at
least 5 days after birth. In general “a modified Finnegan Scoring System was used to measure
the degree to which an infant was experiencing symptoms of opioid withdrawal” (p. 384). In
effort to carry this measure out, scoring was carried out by experienced obstetric and pediatric
nursing staff.
DATA ANALYSIS
In general, descriptive statistics, such as mean and standard deviation, were used to describe
the maternal and infant populations. In addition, differences between categorical data were
tested using Fisher’s exact tests (2013). Further, “differences between continuous data were
tested using t tests when distributional assumptions were met or the Mann-Whitney U test
when the distribution was not approximately normal” (p. 385). Overall, statistical analyses
were performed with Stata software version 11.
FINDINGS/ “Sixty-five women (76%) chose to breastfeed their infants after birth; of the women who
RESULTS initiated breastfeeding in the hospital, 66% were still breastfeeding 6 to 8 weeks postpartum.
Although the data suggest that infants who were breastfed had less severe NAS (mean peak
NAS, 8.83 vs 9.65 on a modified Finnegan Scoring System) and were less likely to require
pharmacologic treatment (23.1% vs 30.0%) than infants who were not breastfed, these results
were not statistically significant” (p. 383).
CRITIQUE In this study, data suggested that infants who were breastfed experienced less severe NAS and
were less likely to require pharmacologic treatment. However, “further research with a larger
cohort is necessary to determine whether these associations are statistically significant” (p.
386). In contrast, abrupt termination of breastfeeding among infants exposed to methadone in
breast milk has been associated with acute withdrawal symptoms. Further, more work with a
larger sample of patients is needed to make a definitive conclusion” (p. 386).
REPLICATION
Interestingly “preliminary results suggest that breastfeeding may reduce the severity of NAS
as well as the likelihood of requiring pharmacologic treatment for NAS” (p. 387) - however,
further studies need to be conducted in effort to confirm these results among a larger group.
LEVEL OF Level IV
RESEARCH/
EVIDENCE
D. With regard to the PICO question - NAS babies, Finnegan score, pharmacological use and length of stay were all identified.
However, the Eat, Sleep, and Console (ESC) model was not addressed in this research article. Even though data suggested that the
infants who were breastfed had less severe withdrawal symptoms and were less likely to require pharmacologic treatment
interventions than infants who were not breastfed, it is still recommended that further research is conducted among a larger group.
ARTICLE CITATION
Patrick, S.W., Schumacher, R.E., Benneyworth, B.D., Krans, E.E., Mcallister, J.M., & Davis, M. M. (2012). Neonatal
Abstinence Syndrome and Associated Health Care Expenditures. JAMA, 307(18) 1934-1940. doi:
10.1001/jama.2012.3951
PURPOSE/
HYPOTHESIS The aim of the study is “to determine the national incidence of NAS and antepartum maternal
opiate use and identify the trends regarding national health care expenditures associated with
NAS between 2000 and 2009” (p. 1934).

FRAMEWORK
SAMPLE/ SETTING Infants with NAS were identified from a retrospective, serial, cross-sectional analysis of
discharges in 2000, 2003, 2006, and 2009, through using the Healthcare Cost and Utilization
Project's (HCUP) Kids’ Inpatient Database (KID) (p. 1934).
In general, the International Classification of Diseases, Ninth Revision, Clinical Modification
(ICD-9-CM) diagnosis codes used included “779.5 (drug withdrawal syndrome in a newborn)
in any 1 of 15 discharge diagnosis fields” (p. 1934)
VARIABLES A comparison between NAS babies and all other hospital births based on costs and length of
STUDIED stay due to respiratory issues, low birthweight, feeding difficulties, and seizures.
DESIGN Retrospective, serial, cross-sectional

THREATS TO A number of limitations were identified in the study including relying solely on data in which
INTERNAL & errors of coding and omission could have potentially occurred as well as hospital billing data
EXTERNAL solely underreporting the clinical diagnosis of NAS. Further, hospital-billing practices might
VALIDITY have also changed over the course of the study accounting for the reported increase in hospital
charges for NAS.
MEASUREMENT “Incidence of NAS and maternal opiate use, and related hospital charges” (p. 1934).
DATA ANALYSIS Overall, statistical comparisons were performed using STATA version 11.1. Interestingly “the
statistical significance of all time trends was analyzed by assessing P for trend across the 4
study years by using variance-weighted regression for categorical and continuous variables”
(p. 1935). In addition “all testing was 2-sided, with data reported with SEs or 95% confidence
intervals” (p.1936).
FINDINGS/ Between 2000 and 2009, a substantial increase in the incidence of NAS and maternal opiate
RESULTS use in the United States was observed, as well as hospital charges related to NAS (p. 1935).
CRITIQUE Overall, there are a number of limitations identified in the study. In addition, considering this
is the first study to assess trends in NAS and maternal opioid use in the United States - more
studies would need to be conducted in order to determine trends.
REPLICATION
Overall “additional consideration is that newborns with NAS are frequently cared for in
neonatal intensive care units, which are more costly than care in a general pediatric ward” (p.
1940). As such, further studies can focus on delivering care outside of the NICU in regard to
the length of stay and cost.
LEVEL OF Level IV
RESEARCH/
EVIDENCE
D. With regard to the PICO question, NAS babies and length of stay were addressed; however, the Eat, Sleep, and Console (ESC)
model and the Finnegan scale were not mentioned. Nonetheless, with the substantial increase in NAS and maternal opiate use in the
United States between 2000 and 2009 as well as the hospital charges related to NAS - it is evident that more needs to be done in this
area.
ARTICLE CITATION
Wachman, E.M., Grossman, M., Schiff, D.M., Philipp, B.L., Minear, S., Hutton, E., & Whalen, B.L. (2018). Quality
improvement initiative to improve inpatient outcomes for Neonatal Abstinence Syndrome. Journal of Perinatology,
38(8), 1114–1122. doi: 10.1038/s41372-018-0109-8
PURPOSE/
HYPOTHESIS The aim of the study was to “improve Neonatal Abstinence Syndrome (NAS) inpatient
outcomes through a comprehensive quality improvement (QI) program” (p. 1114).

FRAMEWORK
SAMPLE/ SETTING Inclusion criteria included opioid-exposed infants ≥36 wk

N = 240
VARIABLES Compared “pre- and post-intervention on NAS outcomes after a Q1 initiative, which included
STUDIED a nonpharmacologic care bundle, function-based assessments consisting of symptom
prioritization, use of early version of ESC, or a switch to methadone for pharmacologic
treatment” (p. 1114).
THREATS TO This study had a number of threats to internal and external validity. One limitation was that
INTERNAL & there were differences in the co-exposures of the mothers with more infants exposed to illicit
EXTERNAL drugs and benzodiazepines, which psychiatric medications have been associated with worse
VALIDITY NAS outcomes. Also, another limitation was the use of a “more aggressive initiation of
pharmacologic treatment with the use of two Finnegan scores ≥8 or one score ≥12 originally,
which could have led to overtreatment during this phase” (p. 1115). Further, given the
comprehensive QI bundle utilized – the researchers were unable to isolate the effect of
methadone from other interventions on NAS outcomes.
MEASUREMENT The primary outcome measure was hospital length of stay due to NAS when pharmacotherapy
was not required when hospitalization was prolonged for social reasons.
Secondary measures included “any pharmacologic treatment, treatment with an adjunctive

pharmacologic agent (phenobarbital or clonidine), opioid treatment days, breastfeeding
initiation (any amount of breast milk consumed by the infant), and hospital charges (as
determined by the mean charges per day for inpatient pediatrics for a diagnosis of NAS for
corresponding fiscal year)” (p. 1117).
DATA ANALYSIS Overall, statistical process control (SPC) charts and P-charts were utilized. In addition,
independent sample t tests were used for continuous variables, Chi square test of
independence for categorical variables to compare outcomes between the pre- and post
intervention periods, and SAS version 9.4 (SAS Institute, Inc, Cary, NC) for the analysis.
FINDINGS/ Decreases were found in pharmacological treatment from

RESULTS “87.1% to 40.6%, adjunctive agent use from 33.6% to 2.4%, hospitalization rates down from
17.4 to 11.3 d, and opioid treatment days from 16.2 to 12.7” (p. 1122).
CRITIQUE Overall, the study presented a comprehensive QI program focused on non-pharmacologic

care, function-based assessments, and methadone, which resulted in significant sustained
improvements; however, there are several limitations to this study. Further, all hospitals may
not be able to modify their physical space to implement rooming-in.
REPLICATION
A long-term follow-up was not performed on this cohort to evaluate the impact of the
interventions. Also, it is unknown if infants returned for readmission to another hospital, or
had higher utilization of primary or urgent care services.
LEVEL OF Level VI
RESEARCH/
EVIDENCE
D. With regard to the PICO question, the Eat, Sleep, and Console (ESC) model, Finnegan scale, length of stay were all addressed.
Overall, although the study had limitations, it also offered important implications. For instance, based on the findings “it provides
evidence that hospitals should implement models of care that promote parental engagement and other important nonpharmacologic
care measures to improve NAS outcomes” (p. 1121). As such, by implementing a similar QI initiative it is argued to decrease the
need for pharmacologic treatment and lead to subsequent shorter hospitalizations as well as result in significant cost savings. Further,
it can also offer “potential long-term benefits for both the mother and the infant including improved infant attachment and maternal
resilience and confidence in the care of her infant” (p. 1121).
ARTICLE CITATION
Welle-Strand, G. K., Skurtveit, S., Jansson, L. M., Bakstad, B., Bjarko, L., & Ravndal, E. (2013). Breastfeeding reduces
the need for withdrawal treatment in opioid-exposed infants. Acta Paediatrica, 102(11), 1060–1066. doi:
10.1111/apa.12378
PURPOSE/ The aim of the study was to “examine the rate and duration of breastfeeding in a cohort of
HYPOTHESIS women in opioid maintenance treatment (OMT) in Norway, as well as the effect of
breastfeeding on the incidence and duration of neonatal abstinence syndrome (NAS)” (p.
1060).

FRAMEWORK
SAMPLE/ SETTING
A national cohort of 124 women treated with either methadone or buprenorphine during
pregnancy, and their neonates born between 1999 and 2009, was evaluated in three study
parts.
- The first part was a retrospective study and took place from 1999 to 2003 (n = 36).
- The second was a prospective study from 2005 to February 2007 (n = 36).
- The third part was a retrospective study, which included the year 2004 and the period
from 2007 to March 2009 (n = 52).
VARIABLES A comparison between the characteristics of women who breastfeed to those who did not
STUDIED breastfeed, as well as the neonatal outcomes. Also, a comparison of the effect of breastfeeding
on both methadone and buprenorphine-exposed neonates.
DESIGN Mixed method (Retrospective cohort study and Prospective cohort study)
THREATS TO Threats to internal and external validity in this study includes that “there was only one part of
INTERNAL & the study that had a prospective design, and the retrospectively designed study period data
EXTERNAL may be less accurate due to reliance on subject recall. Secondly, the children were born at 18
VALIDITY different hospitals, with varying experience and quality in the assessment of NAS, both
between and within hospitals. Thirdly, the questionnaire did not cover the extent of
breastfeeding, so we do not know for how many and for how long the women were
exclusively breastfeeding. Lastly, the study groups, especially for buprenorphine, were small,
and we had insufficient power to detect significant differences” (p. 1065).
MEASUREMENT “Breastfeeding rates and duration were compared by type of OMT medication (methadone vs.
buprenorphine). Most women in both MMT (74%) and BMT (78%) initiated breastfeeding of
their infants after delivery. The rates of breastfeeding at 4, 8, 12, 26 and 52 weeks of infant
age were 58/56%, 53/39%, 46/34%, 21/15% and 7/5% for women in MMT and BMT,
respectively. The median length of breastfeeding was 12 weeks for women in MMT and 7
weeks for women in BMT” (p. 1062).
DATA ANALYSIS
“Continuous variables were compared using independent samples t-tests or Mann–Whitney U-
test if the variables were not normally distributed. Discrete variables were compared using v2
tests. A significance level of 5% was chosen for all tests of significance” (p. 1062).
FINDINGS/ Overall “there were high initiation rates of breastfeeding (77%) for women in OMT, but also
RESULTS high rates of early cessation of breastfeeding” (p. 1060). In other words, these women often
need more support to initiate and continue breastfeeding compared to other women. In
addition, the study revealed that “breastfed neonates exposed to methadone prenatally had
significantly lower incidence of NAS requiring pharmacotherapy (53% vs. 80%), and both the
whole group of infants and the methadone-exposed neonates needed shorter pharmacological
treatment of NAS (p < 0.05) than neonates who were not breastfed” (p. 1060).
CRITIQUE This study had several limitations. However, one that really stood out was how some of the
study groups, specifically buprenorphine, were small. With that being said, this led to the
study not showing significant differences. Considering this medication could be dangerous,
larger clinical groups need to be studied.
REPLICATION Overall, “breastfed neonates, who have been exposed to OMT medication prenatally and
methadone-exposed newborns in particular, require shorter pharmacological NAS treatment
than infants who were not breastfed” (p. 1065). However, these women require more support
to both initiate and to continue breastfeeding. As such, a study could examine if support and
continuous education do make a difference in this regard. Further “there is a need for more
research, especially concerning the effect of lactation on NAS for neonates of women in
BMT” (p. 1065).
LEVEL OF Level IV
RESEARCH/
EVIDENCE
D. In regards to our PICO question, NAS babies, Finnegan score, and pharmacological use were identified. The length of stay and the
eat, sleep, and console method were not discussed. Although this study did not give us enough information in regards to our PICO
question, it was beneficial in regards to shortening the duration of NAS treatment for the total group of breastfed neonates compared
to neonates who were not breastfed.
Following Guideline Possible Points Points Earned
Introduction 5 Points
PICO Question 5 Points
Table of Findings 50 Points
Evaluate Current Use of

20 Points
Research Findings
Recommendations for
5 Points
Nursing Practice
Recommendations for
5 Points
Future Research
Format 10 Points
Total Possible Points 100 Poin

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Running Head: Eat, Sleep, and Console

Evidence Based Project

Sharon Oetker- Black RN, PhD, JD, ANEF, FAAN

April 19, 2020

put, NAS refers to a “constellation of neurologic, gastrointestinal, and musculoskeletal

tremors, irritability, excessive or high-pitched crying, sleep problems, hyperactive reflexes,

nonpharmacologic interventions, if possible, or starting morphine at 0.05 mg/kg every 3 hours”

infant’s length of stay in the NICU/SCN?

that received sublingual buprenorphine compared with conventional oral methadone

alone” (Coyle, 2002, p. 561).

Academy of Pediatrics clinical report on neonatal withdrawal “drug therapy is indicated to

and seizures if an infant does not respond to a committed program of non-pharmacologic

by Hendree et al (2016) compared psychometric characteristics of the Neonatal Abstinence

measurement characteristics” (p. 371).

implemented the ESC model.

Also, it is the responsibility of the physician/APP to order pharmacologic treatment for

Assessment Tool is considered to be a “kinder, gentler approach to NAS assessments” (“NAS

provided there is no clinical apnea/bradycardia. Nonetheless, even though nurses continue to

ranging from literature reviews to retrospective studies as well as a number of informative

an increase in trust, confidence, and a reparative relationship. Moreover, it is a collaborative

Moreover, a study conducted by Bagley et al (2014) revealed “non-pharmacologic interventions

implementation in nursing practice is to continue to ensure that the newborn is eating an

minutes. If not, non-pharmacologic interventions should be increased including a second

team should be notified (Graham et al., 2019).

By contrast, non-pharmacologic interventions include several other components. For

comfortable a three-step implementation process occurs simultaneously: identification of a point

reduction in postnatal use of opioids. According to the study completed by Wachman et al

(Krans et al., 2015, p. 370).

improves the Finnegan score regarding eat, sleep, and consoling.

methadone prenatally had significantly lower incidence of NAS requiring pharmacotherapy

and possibly compromise her sobriety.

Interestingly, the American Academy of Pediatrics and American Academy of Family

scale, the literature appears to be quite promising. According to Wachman et al (2018),

implementing non-pharmacologic care resulted in a decrease need for pharmacologic treatment

issues with the Ohio Department of Health (ODH) audits.

and management of neonatal abstinence syndrome. Addiction Science & Clinical

Practice, 9(19), 1-10. doi: 10.1186/1940- 0640-9-19

Term Growth and Development. Retrieved from

Journal of Advanced Nursing, 65(10), 2239–2248. doi: 10.1111/j.1365-

infants. The Journal of Pediatrics, 140(5), 561–564. doi.org/10.1067/mpd.2002.123099

16, 2020, from https://www.cdc.gov/pregnancy/opioids/data.html

(2019). Pharmacological Treatments for Neonatal Abstinence Syndrome: A Systematic

Review and Network Meta-analysis. JAMA Pediatrics, 173(3), 234-243. doi:

American Academy of Pediatrics 2012 Breastfeeding Policy Statement. Breastfeed

Medicine, 7(5), 323–324. doi: 10.1089/bfm.2012.0067

sleep, console approach: A family-centered model for the treatment of neonatal

abstinence syndrome. Advances in Neonatal Care, 19(2), 138-144. doi:

Grossman, M. R. (2018, October 29). Reconsidering the Standard Approach to Neonatal

Abstinence Syndrome. [Video File]. Retrieved from

Neonatal Abstinence Syndrome. Pediatrics, 139(6). doi: 10.1542/peds.2016-3360

(2016). A Cohort Comparison of Buprenorphine versus Methadone Treatment for

Neonatal Abstinence Syndrome. The Journal Of Pediatrics. Retrieved from

on Addictions, 25(5), 370-373. doi: 10.1111/ajad.12388

(2016). Rooming-in to Treat Neonatal Abstinence Syndrome: Improved Family-Centered

assessment and pharmacologic management. Journal of opioid management, 5(1),

Syndrome. doi: 10.1056/NEJMoa1614835

women: Prenatal and postpartum care considerations. Clinical Obstetrics and

Gynecology, 58(2), 370–379.

NAS Mahoning Valley Campus. (2019). Retrieved from

https://mykidsnet.chmca.org/sites/pnp/Policies and Procedures/Neonatal

Abstinence Syndrome (NAS), Mahoning Valley Campus.docx

Phenobarbital versus morphine in the management of neonatal abstinence syndrome, a

randomized control trial. BMC Pediatrics, 15(57). doi: 10.1186/s12887-015-0377-9