Study to Assess the Incidence of Intussusception in Child... | NCT01177839

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

NCT01177839

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Nov 22, 2012Estimated

Enrollment

178Actual

Phase

Not provided

Conditions

Intussusception

Interventions

Screening sheets

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Aug 6, 2010

First Submission Date that Met QC Criteria

Aug 6, 2010

First Posted Date

Aug 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2012

Last Update Posted Date

Nov 22, 2012Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

178Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intussusception cohort		Subjects with Intussusception	Other: Screening sheets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Screening sheets	Other	Reviewing screening sheets	Intussusception cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of definite, probable and possible IS cases in children < 5 yrs of age		Average timeframe: one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

24 Months

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Singapore		119074	Singapore
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24103115	Derived	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.

ID	Term
D007415	Intestinal Obstruction
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases