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

November 21, 2012 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • GSK Investigational Site
      • Singapore, Singapore, 169608
        • GSK Investigational Site
      • Singapore, Singapore, 228510
        • GSK Investigational Site
      • Singapore, Singapore, 229899
        • GSK Investigational Site
      • Singapore, Singapore
        • GSK Investigational Site

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 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All subjects < 24 months of age seen on an in- or out-patient basis with a diagnosis of intussusception during at least a one year period beginning at study start.

Description

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 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: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intussusception cohort
Subjects with Intussusception
Other: Screening sheets
Reviewing screening sheets

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2002

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

August 6, 2010

First Submitted That Met QC Criteria

August 6, 2010

First Posted (Estimate)

August 9, 2010

Study Record Updates

Last Update Posted (Estimate)

November 22, 2012

Last Update Submitted That Met QC Criteria

November 21, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999910/193

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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