Less invasive surfactant administration versus

intubation for surfactant delivery in preterm

infants
with respiratory distress syndrome: a
systematic
review and meta-analysis
Research Plan

A. Rationale

Less-invasive surfactant administration (LISA) is a procedure used to

administer surfactant through a thin catheter instead of a tube . This procedure

along with Continuous Positive Airway pressure (CPAP) helps avoid the use of

mechanical ventilation and reduce the risk of bronchopulmonary dysplasia.

INtubation, SURfactant, Extubation (INSURE) is a procedure that is

administered via endotracheal intubation, along with manual lung ventilation

(leone, 2013).

Respiratory distress syndrome (RDS) is a disorder that affects the breathing of

a newborn, it usually occurs in preterm infants (Respiratory Disease Syndrome,

2019). The lack of surfactant that coats the alveoli may lead to the alveoli closing. If

left untreated, pediatric respiratory distress syndrome can cause brain damage,

organ damage or death (Wikipedia, 2020).

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 B. Research Question,Hypotheses, Goals, Expected Outcomes

Research Question: Can LISA help reduce the risk of infants with RDS developing

neurodevelopmental disorders?

Hypotheses:

Alternative - LISA has a significant effect in reducing the risk of BPD and Death in

preterm infants.

Null - LISA does not have any significant effect in reducing the risk of preterm

infants developing BPD and lead to death.

Cause and Effect - If Lisa is administered along with CPAP then it would reduce the

risk of BPD and death.

Goals:

A systematic review of randomised controlled trials (RCTs) comparing LISA with the

standard method of surfactant delivery for clinical outcomes.

Expected Outcome:

LISA is a much effective method for surfactant delivery than the other standard

method

C. Procedure

● Search strategy

The research librarian in collaboration with the research team will conduct

structured searches on subject headings and keywords for concepts related to

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surfactant application in preterm infants. The initial search will be conducted

employing the following electronic databases: Ovid Medline (1946 to date),

Cochrane Central Register of Controlled Trials (CENTRAL) via Cochrane Library

(from inception to date) and Ovid Embase (1980 to date).

● Study selection and data extraction

Reviewers will independently search for eligible studies, discrepancies will be

resolved through discussion with a third reviewer. Studies will be included if they

met the following criteria: randomised sequence generation, compared LISA

technique with the standard technique of surfactant delivery involving

endotracheal intubation and measured one or more of the following outcomes:

death and/or BPD at 36-week gestation, need for mechanical ventilation or any

other neonatal morbidities. Data will be extracted by one reviewer using a

standardised form and check independently for accuracy by two other reviewers.

Primary authors of the included studies will be contacted for clarifications and

additional information

● Assessment of bias

Methodological quality will be addressed per the Cochrane risk of bias tool, 25

which includes items for adequacy of random sequence generation, allocation

concealment, blinding of the caregivers and the assessors, incomplete outcome

data reporting or selective reporting. Discrepancies will be resolved through

discussion and consensus among the review team.

D. Risk and precautionary measures

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Risk of bias assessment

Studies that will be gathered will be screened through different measures to avoid

bias and inaccuracy.

E. Data analysis

Data will be analysed using RevMan V.5.3. An a priori sensitivity analysis will be

planned for studies that explicitly state InSurE technique as the method of

surfactant delivery for control group. The study will be reported according to the

PRISMA guidelines. I2 statistic will be calculated for each analysis to quantify

heterogeneity across studies. If there wilp be substantial (I2 > 50%) heterogeneity

detected, the potential cause for its existence will be explored and further

sensitivity analyses will undergo.

F. Bibliography

Respiratory Disease Syndrome. (2019, April 9). National Lung, Heart and Blood

Institute. https://www.nhlbi.nih.gov/health-topics/respiratory-distress-

syndrome#:~:text=Respiratory%20distress%20syndrome%20(RDS)%20is,before

%2028%20weeks%20of%20pregnancy.

Wikipedia. (2020, October 1). Pulmonary Surfactant.

https://en.m.wikipedia.org/wiki/Pulmonary_surfactant

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Leone, F. (2013, April). Efficacy of INSURE during nasal CPAP in preterm infants with

respiratory distress syndrome. Pubmed.

https://pubmed.ncbi.nlm.nih.gov/23612264/

Bhayat, Shetty, S. S. (2020). Less-invasive surfactant administration. Paediatrics and

Child Health, 1. https://doi.org/10.1016/j.paed.2020.01.005