A study to estimate burden of rotavirus diarrhea in children under the age of 24 months
Not Applicable
- Conditions
- Health Condition 1: null- Incidence of severe Rotavirus Gastroenteritis
- Registration Number
- CTRI/2015/10/006287
- Lead Sponsor
- Shantha Biotechnics PvtLtd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 3000
Inclusion Criteria
•Children <= 24 months presenting to Out Patient Department/Emergency with acute diarrhea requiring hospitalization for minimum 6 hours.
•Parents/Legally Acceptable Representative willing to sign ICF for inclusion in the study.
Exclusion Criteria
•Non-resident or not belonging to the predefined population study base
•Subject reporting to hospital with an episode of diarrhea with onset more than 14 days
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢To estimate the incidence of severe rotavirus gastroenteritis (SRVGE) in children below 24 Months <br/ ><br>â?¢To describe the age, regional and seasonal distribution of SRVGE <br/ ><br>â?¢To identify the prevalent circulating strains of rotavirus in the population under surveillance <br/ ><br>Timepoint: NA
- Secondary Outcome Measures
Name Time Method â?¢To estimate the incidence of very severe rotavirus gastroenteritis (VSRVGE) in children below 24 Months. <br/ ><br>â?¢To estimate the incidence of rotavirus gastroenteritis of any severity associated with rotavirus in hospitalized children below 24 Months. <br/ ><br>â?¢To estimate the incidence of hospitalization due to all causes of gastroenteritis in children below 24 Months <br/ ><br>Timepoint: NA
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of rotavirus NSP4 protein contribute to severe gastroenteritis in Indian children under 24 months?
How does Rotavac vaccine efficacy compare to Rotarix and RotaTeq in preventing rotavirus diarrhea in Indian infants?
Which biomarkers like proinflammatory cytokines correlate with severe rotavirus gastroenteritis outcomes in CTRI/2015/10/006287?
What are the incidence rates of dehydration and electrolyte imbalance in rotavirus-infected children under 24 months in India?
How do combination strategies of rotavirus vaccines with zinc supplementation impact diarrhea burden in Indian pediatric populations?