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

October 18, 2012 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

54

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children aged <12 months presenting with IS and covered by the JMDC-MDB database from January 2005 to April 2011.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of IS in subjects aged < 12 months
Time Frame: Between January 2005 and April 2011 (6 years)
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
Time Frame: Between January 2005 and April 2011 (6 years)
Between January 2005 and April 2011 (6 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of IS cases hospitalized more than once among subjects aged < 12 months.
Time Frame: Between January 2005 and April 2011 (6 years)
Between January 2005 and April 2011 (6 years)
Occurrence of IS cases by calendar months and year among subjects aged < 12 months
Time Frame: Between January 2005 and April 2011 (6 years)
Between January 2005 and April 2011 (6 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

November 22, 2011

First Submitted That Met QC Criteria

November 23, 2011

First Posted (Estimate)

November 24, 2011

Study Record Updates

Last Update Posted (Estimate)

October 22, 2012

Last Update Submitted That Met QC Criteria

October 18, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116259

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intussusception

Clinical Trials on Data collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe