Pediatric Gastroenteritis
Conditions
Keywords
Pediatric gastroenteritis, rotavirus infection
Brief summary
This is a 1-year study evaluating hospitalizations and the medical care for the treatment of diarrhea from rotavirus infection in children \< 5 years of age, conducted in four hospitals located in four Brazilian regions. A stool sample from each eligible child passing 3 or more loose stools or watery stools within a period of 24 hours and requiring hospitalization or rehydration therapy (oral or IV rehydration) will be tested for the presence of rotavirus, using standard laboratory procedures (ie, Enzyme Linked Ligand Sorbent Assay, or ELlSA) by all participating hospitals.
Interventions
BIOLOGICALRotavirus Vaccine
This is an observational study evaluating hospitalizations and the medical care for the treatment of diarrhea from rotavirus infection in children \< 5 years of age; however, any rotavirus vaccines used in the children presenting with rotavirus-attributed diarrhea were evaluated, as well the prevalent rotavirus serotypes in this sample for future vaccine development.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No
Inclusion criteria
* a child \< 5 years of age being treated for acute gastroenteritis within 72 hours prior to evaluation in the study hospitals. * outpatient children \< 5 years of age submitted for treatment of acute gastroenteritis within 72 hours prior to evaluation in the study clinics.
Exclusion criteria
* none specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age | 1 year | The total number of hospitalizations for diarrhea in children up to 5 years of age in the 4 Brazilian hospital research centers was reported. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. |
| The Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age | 1 year | The percentage of total hospitalizations for children up to 5 years of age in the 4 Brazilian hospital research centers that were for diarrhea. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. |
| The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by Rotavirus | 1 year | Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. For each geographic location, the number of hospitalizations for diarrhea that was caused by rotavirus was reported. |
| The Percentage of Hospitalizations for Diarrhea That Are Caused by Rotavirus | 1 year | Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. The number of hospitalizations for diarrhea from rotavirus infection was divided by the total number of hospitalizations for diarrhea in the 4 hospital research centers. |
| The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group | 1 year | Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. The number of hospitalizations for diarrhea from rotavirus infection was reported for each age group. |
| The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | 1 year | Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. |
| The Duration of Hospitalization for Participants Enrolled in the Study | From hospital admission to discharge | The mean duration (days) of hospital stay for children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. |
| The Number of Deaths in Hospitalized Participants Enrolled in the Study | 1 year | The number of deaths among children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Children Who Provided a Fecal Sample Children up to 5 years of age hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. | 190 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Fecal sample not collected | 40 |
Baseline characteristics
| Characteristic | Children Who Provided a Fecal Sample |
|---|---|
| Age, Customized | 190 participants |
| Rotavirus Vaccination Received No | 15 Participants |
| Rotavirus Vaccination Received Yes | 175 Participants |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
The Duration of Hospitalization for Participants Enrolled in the Study
The mean duration (days) of hospital stay for children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.
Time frame: From hospital admission to discharge
Population: The population analyzed was all enrolled participants whether or not a fecal sample was obtained.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Children Hospitalized For Diarrhea | The Duration of Hospitalization for Participants Enrolled in the Study | 1.83 days | Standard Deviation 2.65 |
Primary
The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by Rotavirus
Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. For each geographic location, the number of hospitalizations for diarrhea that was caused by rotavirus was reported.
Time frame: 1 year
Population: The population analyzed was children up to 5 years of age hospitalized for diarrhea. A total of 190 of the 230 participants had fecal samples analyzed; 27 of these had stool samples positive for rotavirus.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Children Hospitalized For Diarrhea | The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by Rotavirus | 17 Participants |
| Goiânia (Center-West) | The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by Rotavirus | 3 Participants |
| Porto Alegre (South) | The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by Rotavirus | 0 Participants |
| São Paulo (Southeast) | The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by Rotavirus | 7 Participants |
Primary
The Number of Deaths in Hospitalized Participants Enrolled in the Study
The number of deaths among children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.
Time frame: 1 year
Population: Participants were not followed-up in the study; thus the number of deaths was not known.
Primary
The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age
The total number of hospitalizations for diarrhea in children up to 5 years of age in the 4 Brazilian hospital research centers was reported. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.
Time frame: 1 year
Population: The population analyzed was all enrolled participants whether or not a fecal sample was obtained
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Children Hospitalized For Diarrhea | The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age | 230 participants |
Primary
The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group
Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. The number of hospitalizations for diarrhea from rotavirus infection was reported for each age group.
Time frame: 1 year
Population: The population analyzed was the 27 of 190 participants who had a fecal sample positive for rotavirus.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children Hospitalized For Diarrhea | The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group | Age 0 to 3 months | 2 participants |
| Children Hospitalized For Diarrhea | The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group | Age 4 to 6 months | 0 participants |
| Children Hospitalized For Diarrhea | The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group | Age 7 to 9 months | 0 participants |
| Children Hospitalized For Diarrhea | The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group | Age 10 to 12 months | 1 participants |
| Children Hospitalized For Diarrhea | The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group | Age 13 to 15 months | 3 participants |
| Children Hospitalized For Diarrhea | The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group | Age 16 to 18 months | 2 participants |
| Children Hospitalized For Diarrhea | The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group | Age 19 to 21 months | 1 participants |
| Children Hospitalized For Diarrhea | The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group | Age 22 ato 24 months | 3 participants |
| Children Hospitalized For Diarrhea | The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group | Age 25 to 36 months | 8 participants |
| Children Hospitalized For Diarrhea | The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group | Age 37 to 48 months | 3 participants |
| Children Hospitalized For Diarrhea | The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group | Age >48 months | 4 participants |
Primary
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.
Time frame: 1 year
Population: The population analyzed was all enrolled participants whether or not a fecal sample was obtained
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | January 2010 | 1 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | April 2011 | 12 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | November 2010 | 23 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | May 2011 | 18 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | September 2010 | 24 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | June 2011 | 16 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | August 2011 | 18 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | December 2010 | 7 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | September 2011 | 13 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | August 2010 | 41 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | January 2011 | 5 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | October 2011 | 2 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | July 2011 | 22 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | October 2010 | 7 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | November 2011 | 1 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | February 2011 | 14 Participants |
| Children Hospitalized For Diarrhea | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | March 2011 | 6 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | November 2011 | 0 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | January 2010 | 0 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | August 2010 | 5 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | September 2010 | 8 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | October 2010 | 2 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | November 2010 | 0 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | December 2010 | 0 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | January 2011 | 0 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | March 2011 | 0 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | April 2011 | 2 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | May 2011 | 0 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | August 2011 | 4 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | June 2011 | 2 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | September 2011 | 1 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | October 2011 | 0 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | July 2011 | 2 Participants |
| Goiânia (Center-West) | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | February 2011 | 1 Participants |
Primary
The Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age
The percentage of total hospitalizations for children up to 5 years of age in the 4 Brazilian hospital research centers that were for diarrhea. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.
Time frame: 1 year
Population: The population to be analyzed was all hospitalizations for any reason for children up to 5 years of age in the 4 hospital research centers~The number of total hospitalizations for children up to 5 years of age was not known; thus this outcome measure was not evaluated
Primary
The Percentage of Hospitalizations for Diarrhea That Are Caused by Rotavirus
Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. The number of hospitalizations for diarrhea from rotavirus infection was divided by the total number of hospitalizations for diarrhea in the 4 hospital research centers.
Time frame: 1 year
Population: Children hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Children Hospitalized For Diarrhea | The Percentage of Hospitalizations for Diarrhea That Are Caused by Rotavirus | 14.2 percentage of participants |