Study on the Incidence of Intussusception (IS) in Children Aged < 12 Months in Japan

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT01479491

Collaborator

(none)

Enrollment

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intussusception	Other: Data collection

Study Design

Study Type:

Observational

Actual Enrollment :

54 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Observational Database Study on the Incidence of Intussusception in Children Aged < 12 Months in Japan

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Case Group 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).	Other: Data collection Data source will be the Japan Medical Data Centre Company Limited (JMDC) - JMDC Medical Data Bank (JMDC-MDB) database. Aggregated data (age in months and years and gender) for all subjects recorded in the database and subject-level data for IS cases will be extracted from the database. This database will be reviewed to extract data for the period between January 2005 and April 2011. Cases of IS will be identified using the International Classification of Diseases-10 (ICD-10) diagnostic codes, examination codes and procedural codes.

Arm

Intervention/Treatment

Case Group

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).

Other: Data collection

Data source will be the Japan Medical Data Centre Company Limited (JMDC) - JMDC Medical Data Bank (JMDC-MDB) database. Aggregated data (age in months and years and gender) for all subjects recorded in the database and subject-level data for IS cases will be extracted from the database. This database will be reviewed to extract data for the period between January 2005 and April 2011. Cases of IS will be identified using the International Classification of Diseases-10 (ICD-10) diagnostic codes, examination codes and procedural codes.

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 12 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.