Surveillance of Hospitalizations Due to Rotavirus Infections Among Children From Israel

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Tel Aviv University
Laniado Medical Center Netanya
Carmel Medical Center
The Meshulash Research and Development Center Kfar Qaraa
Ministry of Health, Israel
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT00484952
First received: June 11, 2007
Last updated: July 31, 2007
Last verified: June 2007
  Purpose

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.


Condition
Rotavirus Infections

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Multicenter Study for Surveillance of Hospitalizations Due to Rotavirus-Associated Diarrhea and Estimation of the Economic Burden of Rotavirus Hospitalizations

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Estimated Enrollment: 2500
Study Start Date: September 2007
Estimated Study Completion Date: September 2009
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.

  Eligibility

Ages Eligible for Study:   1 Month to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484952

Contacts
Contact: Eias Kasem, MD +972-4-6304331 eiaska@hy.health.gov.il
Contact: Dani Cohen, MPH, PhD +972-3-640-7591 dancohen@post.tau.ac.il

Locations
Israel
Carmenl Medical Center Not yet recruiting
Haifa, Israel
Contact: Moshe Efrat, MD         
Principal Investigator: Moshe Efrat, MD         
Laniado Medical Center Not yet recruiting
Netanya, Israel
Contact: Uri Robenstien, MD         
Principal Investigator: Uri Robenstein, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center
Tel Aviv University
Laniado Medical Center Netanya
Carmel Medical Center
The Meshulash Research and Development Center Kfar Qaraa
Ministry of Health, Israel
Investigators
Principal Investigator: Dani Cohen, PhD Tel Aviv University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00484952     History of Changes
Other Study ID Numbers: 48/2006
Study First Received: June 11, 2007
Last Updated: July 31, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:
rotavirus
diarrheal diseases
hospitalizations
multicenter
children
under five year old
Hospitalization due to diarhheal diseases
Hospitalization due to rotavirus gastroenteritis
Nosocomial rotavirus infections

Additional relevant MeSH terms:
Communicable Diseases
Infection
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014