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Protocol Version 1.2 Cross-sectional study of acute diarrhoeal Dept. of

Date: 14/01/16 diseases in children under 5 years of age. Community Medicine
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Protocol Version 1.2 Cross-sectional study of acute diarrhoeal Dept. of

Date: 14/01/16 diseases in children under 5 years of age. Community Medicine

Name of Candidate :- Dr. Mane Yogesh Yogiraj

Name of College :- Topiwala National Medical College & B.Y.L. Nair Ch. Hospital,
Mumbai.

Name of Guide :- Dr. Bandi Janardhan

Asst. Professor,
Dept. of Community Medicine,
TN Medical College and B.Y.L. Nair Ch. Hospital,
Mumbai.

Name of Course :- M.D.

Name of Subject: :- Community Medicine

Academic Year :- May 2016 to May 2019

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Protocol Version 1.2 Cross-sectional study of acute diarrhoeal Dept. of

Date: 14/01/16 diseases in children under 5 years of age. Community Medicine

Topic:-

A Cross-sectional study of Prevalence and Risk

factors of Acute diarrhoeal diseases among
under Five children in Rural area

INTRODUCTION
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Protocol Version 1.2 Cross-sectional study of acute diarrhoeal Dept. of

Date: 14/01/16 diseases in children under 5 years of age. Community Medicine

WHO defines diarrhoea as the passage of 3 or more loose or liquid stools per day, or more
frequently than is normal for the individual.(1 )

It is usually a symptom of gastrointestinal infection, which can be caused by a variety of bacterial,

viral and parasitic organisms.

There are three clinical types of diarrhea:

acute watery diarrhoea – lasts several hours or days,
acute bloody diarrhoea – also called dysentery; and
persistent diarrhoea – lasts 14 days or longer. (4)

Diarrhoea is one of the leading causes of death among children under 5 years of age. It is
the 2nd leading cause following Pneumonia, and is responsible for killing around 7,60,000 children
every year globally.(1)

WHO estimates that globally there are nearly 1.7 billion cases of diarrheal diseases every year.
In India, diarrhoea has a prevalence of 8.5% in children under five years of age . (3)During the
(1)

year 2013, about 11.4 million cases with 1,629 deaths were reported in india .
(6)

Diarrhoea contributes to around 10 percent under-five deaths in country.Around 1.2 lac of children
die due to diarrhoea annually in India- most of these deaths are clustered around Summer and
Monsoon season.(8)

Risk factors:
According to Census 2011, over a two third of India's population lives in rural areas.India has
68.8% population in rural area and only 31.2% is in urban area.Child population among under six
children totally is 16.4 million..Among them 12.1 million lives in rural area while remaining 4.31
million lives in urban area.This makes rural area ground for diarrhoeal diseases as they have
socioeconomically poor population living in unsanitary conditions. Lack of safe drinking water,
proper toilet facility, good hygienic practices along with poor nutrition and poor knowledge about
immunization predispose the inhabitants of rural area to diarrhoeal diseases. In India, 49.8% of
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Protocol Version 1.2 Cross-sectional study of acute diarrhoeal Dept. of

Date: 14/01/16 diseases in children under 5 years of age. Community Medicine

people still defecate in the open.(6) Public latrine use accounts to only 3.2% nationally though this
number rises to 12.9% for the State of Maharashtra(6).
Diarrhoea is a leading cause of malnutrition in children under five years old. (4)Undernourished
children are at higher risk of suffering more severe, prolonged and often more frequent episodes of
diarrhoea. Repeated bouts of diarrhoea also place children at a greater risk of worsening nutritional
status due to decreased food intake and reduced nutrient absorption, combined with the child’s
increased nutritional requirements during repeated episodes.(2)

Management:
Improving unsanitary environments alone will not be enough as long as children continue to
remain susceptible to the disease and are not effectively treated once it begins.

1) ORS:The most severe threat posed by diarrhoea is dehydration. During a diarrhoeal

episode, water and electrolytes are lost from the body. Dehydration occurs when these
losses are not replaced effectively.In 2003, WHO/UNICEF recommended use of new ORS
formulation for effective replacement of fluid losses. India adopted it in 2004. Yet today in
India, only 60.5 % of children with diarrhoea receive ORS

According to NFHS-4, about 78.7% of under five children who suffered from diarrhoea in
the last 2. weeks were taken to health facility in rural area. (3)
2) Prevalence of diarrhoea in under five children who received ORS in last 2 weeks in a rural
area is 58.8%.
3) Prevalence of diarrhoea in under five years who received zinc in last 2 weeks in a rural
area is 11.9%.
4) Efficacy of ORS does not only depend upon simply giving it to the suffering child, but
mainly on timely and correct method of administration.
2) Drugs: The use of antibiotics and other antidiarrhoeal drugs is not generally recommended for
the treatment of diarrhoea

3)Feeding: According to UNICEF, diarrhoea can be managed at home by providing children with
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Protocol Version 1.2 Cross-sectional study of acute diarrhoeal Dept. of

Date: 14/01/16 diseases in children under 5 years of age. Community Medicine

an increased amount of fluids, or ORT, and a continuation of usual feeding. Infants who are
exclusively breastfed for the first six months of life and continue to be breastfed until two years of
age and beyond develop fewer infections and have less severe illnesses than those who are not(2) I

4) Zinc: Intensive Diarrhoea Control Fortnight(IDCF) recommends administration of Zinc along

with ORS to every child suffering from diarrhoea to reduce the severity of the episode and
recurrences in the future by increasing immunity.
Adequate zinc intake among children is critical for normal growth and development. Recent
supplementation trials have shown that adequate zinc leads to a substantial reduction in childhood
diarrhoea cases. (2)

RATIONALE:
Diarrhoea is one of the leading causes of death and illness among children under five years of age
in the world. It results in billions of cases per year.India accounts for 21% of Under-5 mortality of
the world(7).Diarrhoeal deaths mainly occur due to dehydration. Current guidelines for
management of diarrhea by the MOHFW, recommend low osmolarity oral rehydration salt
solution (ORS), zinc and continued feeding of energy dense feeds in addition to breastfeeding.
Oral rehydration therapy (ORT) with ORS remains the cornerstone of appropriate case
management of diarrheal dehydration and is considered the single most effective strategy to
prevent diarrheal deaths in children. According to NFHS-4, 78.7% of the mothers reported
consulting a health care provider during the episode of diarrhea. However, only 58.8% of children
used ORS.(3) What makes it even more disturbing is that knowledge of ORS/ORT among mothers
of under-five children in India is good (73%),but there is a big gap between knowledge and
practice as reflected in poor ORS usage rates.(9) Studies have clearly shown a dichotomy between
knowledge and practice regarding this life-saving measure. Hence, a need is felt to look into this
particular aspect of diarrhea control and study the factors affecting/causing this huge gap.
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Protocol Version 1.2 Cross-sectional study of acute diarrhoeal Dept. of

Date: 14/01/16 diseases in children under 5 years of age. Community Medicine

AIM

To study the prevalence of acute diarrhoeal diseases and the associated epidemiological factors in
children under 5 years of age in an rural area.

OBJECTIVES

1. To find out the prevalence of acute diarrhoeal diseases in children below 5 years of age
(except neonates).
2. To study the demographic profile and socio-economic factors of the family.
3. To assess the environmental factors of the household and the personal hygiene of the
family members.
4. To assess the immunization status and nutritional status of the children under 5 yrs of
age(except neonates) in the family.
5. To assess the knowledge and practices of mothers/ any other primary care givers regarding
diarrhoea management including ORS.
6. To study the association of the above factors with diarrhoea.
7. To find out the treatment seeking behaviour for children with diarrhoea
8. To make suitable recommendations based on the findings of the study.
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Protocol Version 1.2 Cross-sectional study of acute diarrhoeal Dept. of

Date: 14/01/16 diseases in children under 5 years of age. Community Medicine

MATERIALS AND METHODOLOGY

Study Design:A community based cross-sectional epidemiological study.

Study Area: The study will be conducted in rural field practice area attached to Department of
Community Medicine of parent medical college

Study Population: Children below 5 years of age (except neonates)

Inclusion Criteria:

1.Children below five years of age.

2.Children whose parents are willing to participate in the study.

3.Children whose parents are staying for atleast 3 months in study area

Exclusion Criteria
1) Children whose parents are not present.
2) Children suffering from persistent diarrhoea, or any other severe illness.

3)Neonates

Sample size:

The national prevalence of diarrhea in under 5 children in rural area is 9.9 %

Applying the formula sample size = n = Z p ( 1-p )/ d2

Where

n is sample size
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Protocol Version 1.2 Cross-sectional study of acute diarrhoeal Dept. of

Date: 14/01/16 diseases in children under 5 years of age. Community Medicine

Z is the Z statistics for the desired level of confidence

p is the estimate of expected proportion with the variable of interest in the population

d is precision

Taking 95 % CI,

Z= 1.96

p= 0.099

d= 0.05

we get Z2 = 3.8416

d2= 0.025

1-p= 0.901

p(1-p)= 0.089191

Z2 *p*(1-p)= 0.3426688

There fore sample size n= 138

Sample size of 150 will be taken as there are enough available resources in terms of
time,manpower and infrastructure in order to ensure sufficient data collection for the study.

Sampling Method:

Sample size:150

Total population of study area is 23434

The number of children between 1-5 years of age as enumerated by PHC is 2150.
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Protocol Version 1.2 Cross-sectional study of acute diarrhoeal Dept. of

Date: 14/01/16 diseases in children under 5 years of age. Community Medicine

List will be prepared of these children.From these children first child will be selected from simple
random sampling method and after that with the help of systematic random sampling every 13 th
child will be selected for the study till sample size of 150 is achieved.

If the house is locked or the child does not met the inclusion criteria then next child in the list will
be selected for the study purpose.

Duration of study: 3 MONTHS

Study period:1 AUGUST TO 31 OCTOBER 2018

Phases of Study:

A] Preparatory Phase:
1) Literature search: A proper and authentic literature search was done on the study topic.
2) Administrative approval: Permissions will be sought from the administrative authorities
associath the study area including the Urban Health Centre Incharge, Head of
the Dept., and Dean of the Medical College.
3) Ethics Committee approval: The study will be reviewed by the Ethics Committee for Academic
Research Projects (ECARP) of the medical college and approval will be sought.
4) Constructing tools for data collection.
- Consent forms will be prepared.
- A Pre-structured questionnaire will be taken.
5) Baseline information of study area will be taken from the Health Post.

B] Conducting phase:

1) Selection of Sample:

i)Total population of study area is 23434

i)The number of children of age between 1-5 years enumerated by PHC is 2150.List will be

prepared of these children.

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Protocol Version 1.2 Cross-sectional study of acute diarrhoeal Dept. of

Date: 14/01/16 diseases in children under 5 years of age. Community Medicine

ii)From the list first child will be selected by simple random sampling method

iii)After thatwith the help of systematic random sampling every 13th child will be selected for till

sample size of 150 is achieved.If the house is locked or the child does not met the inclusion criteria

next child in the list will be selected for study purpose.

2) Data collection:

i)The present parent/ guardian will be met with and explained about the study in a language

they understand.

ii) A written informed consent will be taken if they are willing to participate in the study.

iii)Data will be collected using a pre-structured proforma. Questions will be asked

about the demographic and socio-economic details of the family,environmental conditions
of the house, personal hygiene of the family members and feeding practices of the child.
Parents/Primary care givers (if any other) will also be asked about diarrhea management
methods that are adopted when child gets diarrhoea. Child’s immunization status will be
determined by checking the immunization card or by history taking from the parent (if card
is not available).
Height will be measured by using a measuring tape that is calibrated in centimeters,
by taking crown to heel length. Weight will be measured by using a weighing machine
calibrated in kilograms. For infants/ those children who cannot stand, weight will be
measured using a foldable infantometer. Mid upper arm circumference (MUAC) will
be measured by using a measuring tape calibrated in centimeters.
Nutritional status of the child will be then determined by using WHO growth charts.
A general and systemic examination of the child will also be carried out to check for
any concurrent illnesses.
iv) To maintain privacy, all information will be collected ensuring the respondent’s comfort.
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Protocol Version 1.2 Cross-sectional study of acute diarrhoeal Dept. of

Date: 14/01/16 diseases in children under 5 years of age. Community Medicine

C]Analysis and Documentation phase:

1) Data collected will be entered in Microsoft Excel Spreadsheet.
2) Data will be analyzed using tables, graphs and bar diagrams.
3) Analysis will include descriptive statistics.
4) Qualitative and quantitative data will be analyzed using SPSS Software 20.
5) Results will be interpreted and compared with various previous studies.

REFERENCES

1. 1. Who.int. WHO | Diarrhoea [Internet]. 2016 [cited 1 September 2016]. Available from:
http://www.who.int/topics/diarrhoea/en/

2. [Internet]. 1st ed. ISBN 978-92-806-4462-3 (UNICEF) ISBN 978-92-4-159841-5 (NLM

classification: WS 312) (WHO); 2009 [cited 1 September 2016]. Available from:
http://apps.who.int/iris/bitstream/10665/44174/1/9789241598415_eng.pdf; 13-14.

3. 4. National Family Health Survey-4 [Internet]. 3rd ed. New Delhi: Ministry of Health and
Family Welfare, Govt. of India; 2005 [cited 1 September 2016]. Available from:
http://hetv.org/india/nfhs/nfhs3/NFHS-4-Chapter-09-Child-Health.pdf; 240-243.

4. Who.int. WHO | Diarrhoeal disease Fact Sheet [Internet]. 2013 [cited 1 September 2016].
Available from: http://www.who.int/mediacentre/factsheets/fs330/en/
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Protocol Version 1.2 Cross-sectional study of acute diarrhoeal Dept. of

Date: 14/01/16 diseases in children under 5 years of age. Community Medicine

5. Primary Census Abstract for Slum, 2011 [Internet]. 1st ed. Office of the Registrar General
& Census Commissioner, India; 2013 [cited 1 September 2016]. Available from:
http://www.censusindia.gov.in/2011-Documents/Slum-26-09-13.pdf; 14.

6. National Health Profile 2015 [Internet]. 10th ed. New Delhi: Central Bureau of Health
Intelligence, Directorate General of Health Services, Ministry of Health and Family
Welfare, Govt. of India; 2015 [cited 16 September 2016]. Available from:
http://www.cbhidghs.nic.in/writereaddata/mainlinkFile/NHP-2015.pdf;46,73.

7. Committing to Child Survival: A Promise Renewed – Progress Report 2014 [Internet]. 1st
ed. New York: UNICEF; 2016 [cited 21 September 2016]. Available from:
http://www.unicef.org/publications/index_75736.html ; p.7.

8. IDCF 2016 Intensified Diarrhoea Control Fortnight, 27th July- 8th August, 2016:
OPERATIONAL GUILDELINES [Internet]. 2nd ed. Child Health Division Ministry of
Health and Family Welfare; 2016 [cited 21 September 2016]. Available from:
http://www.nrhm.gov.in/images/pdf/IDCF-2016/IDCF_Guideline.pdf ; p. 2.

9. Lakshminarayanan S, Jayalakshmy R. Diarrheal diseases among children in India: Current

scenario and future perspectives. Journal of Natural Science, Biology and Medicine.
2015;6(1):24. [PubMed] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4367049/