Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore

Completed

• Conditions: Intussusception

• Registration Number: NCT01177839
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This prospective study aims to estimate the incidence of intussusception among children \< 2 years old through hospital-based surveillance in Singapore.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2010-08-06
• Study First Submitted QC: 2010-08-06
• Study First Posted: 2010-08-09
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-21
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• A male or female infant aged < 24months at the time of diagnosis of intussusception.
• Subject is diagnosed with definite, probable, possible, suspected intussusception during the period of at least one year beginning at study start.
• Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria

• A male or female infant ≥ 24 months of age at the time of intussusception diagnosis.
• The subject has had a radiographically or surgically confirmed case of intussusception prior to the current episode.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of definite, probable and possible IS cases in children < 5 yrs of age	Average timeframe: one year

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇬 Singapore, Singapore