NCT01177839

Brief Summary

This prospective study aims to estimate the incidence of intussusception among children \< 2 years old through hospital-based surveillance in Singapore.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2002

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2010

Completed
Last Updated

November 22, 2012

Status Verified

November 1, 2012

Enrollment Period

8.2 years

First QC Date

August 6, 2010

Last Update Submit

November 21, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Occurrence of definite, probable and possible IS cases in children < 5 yrs of age

    Average timeframe: one year

Study Arms (1)

Intussusception cohort

Subjects with Intussusception

Other: Screening sheets

Interventions

Reviewing screening sheets

Intussusception cohort

Eligibility Criteria

AgeUp to 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

GSK Investigational Site

Singapore, 119074, Singapore

Location

GSK Investigational Site

Singapore, 169608, Singapore

Location

GSK Investigational Site

Singapore, 228510, Singapore

Location

GSK Investigational Site

Singapore, 229899, Singapore

Location

GSK Investigational Site

Singapore, Singapore

Location

Related Publications (1)

  • Phua KB, Lee BW, Quak SH, Jacobsen A, Teo H, Vadivelu-Pechai K, Gopala K, Liu Y. Incidence of intussusception in Singaporean children aged less than 2 years: a hospital-based prospective study. BMC Pediatr. 2013 Oct 8;13:161. doi: 10.1186/1471-2431-13-161.

MeSH Terms

Conditions

Intussusception

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2010

First Posted

August 9, 2010

Study Start

May 1, 2002

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

November 22, 2012

Record last verified: 2012-11

Locations