Thesis Protocol

1. TITLE
Prevalence of Rotavirus and Adenovirus among children less
than 5 years presenting with Acute Watery Diarrhoea to a
tertiary care hospital in Pondicherry- A cross-sectional study
• Name of the PG: Dr. N. Zaheen Zehra, Dept. of Paed.
• Guide Dr. D. Gunasekaran, Professor, Dept. of Paed.
• Co-Guide Dr. M. Lalitha, Asst. Prof. Dept. of Paed.
• Co-Guide Dr. R. Kalaivani, Asst. Prof. Dept. of Micro.

2. INTRODUCTION
ACUTE WATERY DIARRHOEA(AWD):
• One of the most common causes of admission to
health centres in under 5 age group
• Second leading cause of death in this age group
• 1.7 billion cases of diarrhoeal diseases reported
every year globally
• Viruses remain the most common etiologic
agents for AWD worldwide

3. INTRODUCTION
ROTAVIRUS AND ADENOVIRUS:
• Important viral causes of AWD in children
worldwide
• 29% of all diarrhoeal deaths in children <5 years
of age is due to Rotavirus
• 23% of Rotavirus deaths are in the Indian
subcontinent

4. WHY THIS STUDY?
• Etiology of AWD varies in different settings-
Studies pertaining to viral etiology of AWD not
been done in areas around Pondicherry
• If viral etiology is proven to be high- more
emphasis on rational use of antibiotics- help
foster antimicrobial stewardship
• Point of care testing- short duration to get
results- will throw some light on the routine use
of this test in the office practice

5. RESEARCH QUESTION
Using the immuno-chromatographic detection
method, What is the prevalence of Rotavirus and
Adenovirus in children less than 5 years of age
presenting with acute watery diarrhea in our
setting?

6. AIM & PRIMARY OBJECTIVE
To determine the prevalence of rotavirus and
adenovirus, using the immuno-chromatographic
stool test in children less than 5 years of age
presenting with acute watery diarrhea to a tertiary
care hospital setting.

7. OBJECTIVES
Secondary:
• To study the clinical profile of children with AWD
• To study the profile of severity of dehydration at
presentation in the studied group
• To study the nature of rehydration therapy and need
for hospitalization
• To try and find the clinical predictors for rotaviral
diarrhea

8. MATERIALS AND METHODS OF STUDY
• Design: Cross sectional study
• Setting: Department of Pediatrics, MGMCRI
over a period of one and half years

9. STUDY DEFINITION for AWD
• Passage of three or more loose or liquid stools
per day in a child who has been passing normal
consistency stools previously
• If baseline frequency itself is 3 or more times of
normal consistency stools- Any recent increase in
the number of stools from the usual frequency
and/ or any recent change in consistency of
stools of the child as reported by the mother
shall also be taken as diarrhea

10. SAMPLE SIZE
• OpenEpi Software version 3.01 used
• Considering the prevalence of Rotavirus
Diarrhoea as 35.8% and confidence level of
95%- Total sample size= 354

11. Inclusion criteria
• All children in the age group 1 month to 5 years of
age who present to the Pediatric outpatient
department/ casualty with acute watery diarrhea
satisfying the study definition would be included into
the study

12. Exclusion criteria
• Neonates (less than 28 days of age)- transitional stools
confounder
• Children with obvious dysentery at admission
• Children with diarrhea for more than or equal to 14 days-
persistent diarrhea
• Children who have received rotavirus vaccination at any
point of time
• Children who develop diarrhea after admission to the
hospital for other illness/ children who develop diarrhea
after treatment with antibiotics for non- gastrointestinal
illness- may be antibiotic associated diarrhea

13. MATERIALS TO BE USED
• VIKIA® Rota-Adeno kits manufactured by Biomerieux
• It is a rapid, qualitative, chromatographic immunoassay
for the simultaneous detection of rotaviruses and
adenoviruses.
• Sensitivity for Rotavirus - 100%
Sensitivity for Adenovirus - 97.6%
• Specificity for both- 100%.

14. PROCEDURE
• 50 mg or 50 µl of the freshly obtained stool sample
• Will be mixed diluents provided and homogenized
• 2 drops are then added to the sample well on the cassette
• Then based on the line that appears, the test is read
(only control line: -ve for rota & adeno virus,
control line plus blue line = + ve for rotavirus,
control line plus red line = adenovirus,
no control line= invalid test and needs to be repeated)
• The total time required is just 10 minutes.

15. STATISTICAL METHODS
Parameter Test to be used
Prevalence of Rotaviral infection among
the study population
Proportion
Prevalence of Adenoviral infection
among the study population
Proportion
Comparison of mean age of rotaviral
subgroup vs adenoviral subgroup
t – Test
Clinical predictors of rotaviral disease Logistic regression
Comparison of severity of dehydration
and complications in rotaviral subgroup
with others
Chi Square Test

16. Child age < 5 years with AWD, satisfying the study definition- Inclusion
& Exclusion Criteria.
Informed consent
Collection of clinical and demographic data
Stool sample tested- Rota + / Adeno + / -ve for both
Record data onto a database
Statistical Analysis

17. ETHICAL ISSUES
• This is an observational study. Stool sample is required
for the test. Obtaining stool sample will be in a non-
invasive manner. The Test will be done free of cost.
• Management of the child will be done by the treating
doctors using standard protocols.
• Consent will be obtained from parents to allow us to
utilize the clinical details, lab reports and the
management details of their children for analysis. Care
will be taken to anonymise the obtained data and to
keep them confidential. Only if they give written
consent, their children will be included in the study

18. THANK YOU