Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01177839
First received: August 6, 2010
Last updated: November 21, 2012
Last verified: November 2012
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Purpose
This prospective study aims to estimate the incidence of intussusception among children < 2 years old through hospital-based surveillance in Singapore.
| Condition | Intervention |
|---|---|
|
Intussusception |
Other: Screening sheets |
| Study Type: | Observational |
| Study Design: | 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 |
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of definite, probable and possible IS cases in children < 5 yrs of age [ Time Frame: Average timeframe: one year ] [ Designated as safety issue: No ]
| Enrollment: | 178 |
| Study Start Date: | May 2002 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Intussusception cohort
Subjects with Intussusception
|
Other: Screening sheets
Reviewing screening sheets
|
Eligibility| Ages Eligible for Study: | up to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177839
Locations
| Singapore | |
| GSK Investigational Site | |
| Singapore, Singapore, 119074 | |
| GSK Investigational Site | |
| Singapore, Singapore, 228510 | |
| GSK Investigational Site | |
| Singapore, Singapore, 229899 | |
| GSK Investigational Site | |
| Singapore, Singapore, 169608 | |
| GSK Investigational Site | |
| Singapore, Singapore | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01177839 History of Changes |
| Other Study ID Numbers: | 999910/193 |
| Study First Received: | August 6, 2010 |
| Last Updated: | November 21, 2012 |
| Health Authority: | Singapore: Health Sciences Authority |
Additional relevant MeSH terms:
|
Intussusception Intestinal Obstruction Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013