Study on the Incidence of Intussusception (IS) 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.

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Key information

Conditions

Intussusception Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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.

Primary outcomes

Occurrence of IS in subjects aged < 12 months

Time frame: 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)

Secondary outcomes

Number of IS cases hospitalized more than once among subjects aged < 12 months.

Time frame: 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)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Nov 24, 2011
Registry last updated: Oct 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed