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Surveillance of Hospitalizations Due to Rotavirus Infections Among Children From Israel

NCT00484952 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2007-08-01

No results posted yet for this study

Summary

Objectives

1. To determine the burden and characteristics of rotavirus-associated hospitalizations among children under five years of age of northern Israel
2. To identify potential risk factors of rotavirus infections associated with hospitalizations among Jewish and Arab children younger than five years of age.

Methods:

Study design: A two-year prospective study and a nested case control study will be carried out Collection of data: Questionnaires will be filled in with demographic characteristics of patients and data on the clinical manifestation of the diarrheal episode leading to hospitalization. Stool specimens will be systematically collected from all children hospitalized because of diarrheal diseases and examined for rotavirus and for bacterial and protozoan enteropathogens. Positive samples for rotavirus will be tested for G and P genotypes.

For the nested case control study additional data will be obtained from parents' interviews on variables such as: parents' education, parents' age, parents' occupation, no. of siblings, age of siblings, breastfeeding etc. to identify potential risk factors for rotavirus diarrhea necessitating hospitalization.

Data analysis: Methods of descriptive statistics / epidemiology will be applied to determine the characteristics of the burden of rotavirus-associated hospitalizations (the distribution of diarrhea associated hospitalizations by etiology, rates of rotavirus diarrheal diseases in Jewish and Arab children, age specific rates of rotavirus infections, the percentage of hospitalizations due to rotavirus diarrhea by month, etc.

For the nested case control study, univariate analysis will be first performed using Student t test for continuous variables and chi square test for categorical variables to study the statistical significance of predictive factors of rotavirus diarrheal diseases necessitating hospitalization. Multivariate analysis using logistic regression models will be performed to study the independent effect of each variable. Odds ratios (OR) and 95% CI will be computed for each variable. Two tailed p \< 0.05 will be considered significant.

Conditions

  • Rotavirus Infections

Sponsors & Collaborators

  • Tel Aviv University

    collaborator OTHER

  • Laniado Hospital

    collaborator OTHER

  • Carmel Medical Center

    collaborator OTHER

  • The Meshulash Research and Development Center Kfar Qaraa

    collaborator UNKNOWN

  • Ministry of Health, Israel

    collaborator OTHER_GOV

  • Hillel Yaffe Medical Center

    lead OTHER_GOV

Principal Investigators

  • Dani Cohen, PhD · Tel Aviv University

Eligibility

Min Age
1 Month
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Completion
2009-09-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00484952 on ClinicalTrials.gov