Surveillance of Hospitalizations Due to Rotavirus Infections Among Children From Israel

July 31, 2007 updated by: Hillel Yaffe Medical Center

Multicenter Study for Surveillance of Hospitalizations Due to Rotavirus-Associated Diarrhea and Estimation of the Economic Burden of Rotavirus Hospitalizations

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

Rationale: Vaccination against rotavirus is the most appropriate mean for prevention and control of rotavirus infections. Israel is highly endemic for diarrheal diseases but limited data exist on the burden & epidemiology of rotavirus diarrheal diseases. Such data are essential to assess the relevance of potential future vaccination against rotavirus-associated gastroenteritis in Israel.

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 Study population: About 45000 children aged less than five years, residing in the catchment areas of three pediatric wards of sentinel hospitals (Laniado - Netanya, Carmel - Haifa & Hillel Yaffe -Hadera) will be under daily surveillance for hospitalizations due to rotavirus diarrheal diseases for two years. The catchment area of the 3 hospitals has a good representation of both Jewish and Arab pediatric population. During the study period we expect 400 hospitalizations due to diarrheal diseases and 80 hospitalizations due to rotavirus gastroenteritis annually, in each of the three hospitals (i.e. 480 cases of rotavirus- diarrheal disease in the two year study). 100 subjects hospitalized because of rotavirus associated diarrhea and 100 controls matched by age, gender and origin will be recruited for the nested case-control study.

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.

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Haifa, Israel
        • Carmenl Medical Center
        • Contact:
          • Moshe Efrat, MD
        • Principal Investigator:
          • Moshe Efrat, MD
      • Netanya, Israel
        • Laniado Medical Center
        • Contact:
          • Uri Robenstien, MD
        • Principal Investigator:
          • Uri Robenstein, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: under five year old
  • Hospitalization due diarrheal disease within the study period in the pediatric wards participating in the study
  • Controls: hospitalization due non-gastrointestinal causes within the study period in the pediatric wards participating in the study

Exclusion Criteria:

  • Refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Defined Population
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Collaborators

Tel Aviv University
Laniado Hospital
Carmel Medical Center
Ministry of Health, Israel
The Meshulash Research and Development Center Kfar Qaraa

Investigators

  • Principal Investigator: Dani Cohen, PhD, Tel Aviv University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

June 11, 2007

First Submitted That Met QC Criteria

June 11, 2007

First Posted (Estimate)

June 12, 2007

Study Record Updates

Last Update Posted (Estimate)

August 1, 2007

Last Update Submitted That Met QC Criteria

July 31, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 48/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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