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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: August 6, 2010
Last updated: November 21, 2012
Last verified: November 2012
This prospective study aims to estimate the incidence of intussusception among children < 2 years old through hospital-based surveillance in Singapore.

Condition Intervention
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


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.

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 identifier: NCT01177839

GSK Investigational Site
Singapore, Singapore
GSK Investigational Site
Singapore, Singapore, 119074
GSK Investigational Site
Singapore, Singapore, 169608
GSK Investigational Site
Singapore, Singapore, 228510
GSK Investigational Site
Singapore, Singapore, 229899
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline 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:
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Intestinal Obstruction processed this record on November 27, 2015