Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01177839
Collaborator
(none)
178
5
98
35.6
0.4
Study Details
Study Description
Brief Summary
This prospective study aims to estimate the incidence of intussusception among children < 2 years old through hospital-based surveillance in Singapore.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
178 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Prospective, Hospital-based, Multicentre Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore
Study Start Date
:
May 1, 2002
Actual Primary Completion Date
:
Jul 1, 2010
Actual Study Completion Date
:
Jul 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Intussusception cohort Subjects with Intussusception |
Other: Screening sheets
Reviewing screening sheets
|
Outcome Measures
Primary Outcome Measures
- Occurrence of definite, probable and possible IS cases in children < 5 yrs of age [Average timeframe: one year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 24 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Singapore | Singapore | 119074 | |
| 2 | GSK Investigational Site | Singapore | Singapore | 169608 | |
| 3 | GSK Investigational Site | Singapore | Singapore | 228510 | |
| 4 | GSK Investigational Site | Singapore | Singapore | 229899 | |
| 5 | GSK Investigational Site | Singapore | Singapore |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01177839
Other Study ID Numbers:
- 999910/193
First Posted:
Aug 9, 2010
Last Update Posted:
Nov 22, 2012
Last Verified:
Nov 1, 2012
Additional relevant MeSH terms: