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

Intussusception Clinical Trial

Official title:

Prospective, Hospital-based, Multicentre Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177839
• Other study ID #: 999910/193
• Status: Completed
• Phase: N/A
• First received: August 6, 2010
• Last updated: November 21, 2012
• Start date: May 2002
• Est. completion date: July 2010

Study information

• Verified date: November 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intussusception

Intervention

Other:
• Screening sheets
Reviewing screening sheets

Locations

Country	Name	City	State
Singapore	GSK Investigational Site	Singapore
Singapore	GSK Investigational Site	Singapore
Singapore	GSK Investigational Site	Singapore
Singapore	GSK Investigational Site	Singapore
Singapore	GSK Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of definite, probable and possible IS cases in children < 5 yrs of age		Average timeframe: one year	No