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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01479491

Enrollment

Registered

2011-11-24

Start date

2011-11-30

Completion date

2011-11-30

Last updated

2012-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intussusception

Keywords

Japan, Retrospective, Observational, Epidemiological study, Children aged < 12 months, Intussusception

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.

Interventions

OTHERData 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.

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Months

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.

Exclusion criteria

Not applicable

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026