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

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ClinicalTrials.gov Identifier: NCT01177839
Recruitment Status : Completed
First Posted : August 9, 2010
Last Update Posted : November 22, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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
Intussusception Other: Screening sheets

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 2002
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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



Primary Outcome Measures :
  1. Occurrence of definite, probable and possible IS cases in children < 5 yrs of age [ Time Frame: Average timeframe: one year ]


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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177839


Locations
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
GSK Investigational Site
Singapore, Singapore
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

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
First Posted: August 9, 2010    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Intussusception
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases