Rotavirus Infections Clinical Trial
Official title:
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.
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.
;
Observational Model: Defined Population, Time Perspective: Longitudinal
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