Study on the Incidence of Intussusception (IS) in Children Aged < 12 Months in Japan
Completed
- Conditions
- Intussusception
- Interventions
- Other: Data collection
- Registration Number
- NCT01479491
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study aims to analyse baseline data on IS in order to monitor the possibility of increased risk of IS in children aged \<12 months after introduction of the Rotarix vaccination in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- A male or female infant aged < 12 months at the time of IS diagnosis and affiliated to the JMDC-MDB database.
- An IS case should be identified as per the ICD-10 diagnostic code-K56.1 (any-field listed), examination codes, and procedural codes.
Exclusion Criteria
Not applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Case Group Data collection Children aged \< 12 months presenting with IS and covered by the Japan Medical Data Centre Company Limited (JMDC), Tokyo referred to as the JMDC Medical Data Bank (JMDC-MDB).
- Primary Outcome Measures
Name Time Method Occurrence of IS in subjects aged < 12 months Between January 2005 and April 2011 (6 years) Occurrence of age-specific and gender-specific incidence of IS among subjects aged < 12 months in Japan Between January 2005 and April 2011 (6 years)
- Secondary Outcome Measures
Name Time Method Number of IS cases hospitalized more than once among subjects aged < 12 months. Between January 2005 and April 2011 (6 years) Occurrence of IS cases by calendar months and year among subjects aged < 12 months Between January 2005 and April 2011 (6 years)