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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01177839
First received: August 6, 2010
Last updated: November 21, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Intestinal Obstruction

ClinicalTrials.gov processed this record on October 20, 2014