IntussusceptionNCT01177839
Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore
An observational study of Intussusception, run by GlaxoSmithKline at 5 sites in Singapore.
Trial summary
This prospective study aims to estimate the incidence of intussusception among children < 2 years old through hospital-based surveillance in Singapore. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Intussusception
- What is being tested?
- Screening sheets
- How many people
- 178 participants
- Where
- 5 sitesSingapore
- Study dates
- May 2002to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Singapore5 sites
GSK Investigational Site
Singapore, 119074
GSK Investigational Site
Singapore, 169608
GSK Investigational Site
Singapore, 228510
GSK Investigational Site
Singapore, 229899
GSK Investigational Site
Singapore
About this study
Official title: Prospective, Hospital-based, Multicentre Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore
This prospective study aims to estimate the incidence of intussusception among children < 2 years old through hospital-based surveillance in Singapore.
- Conditions
- Intussusception
- Being tested
- Screening sheets
- Medical subject headings
- Intussusception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening sheetsOther
Reviewing screening sheets
| Study group | Role | What they receive |
|---|---|---|
| Intussusception cohort | Subjects with Intussusception Receives: Other: Screening sheets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of definite, probable and possible IS cases in children < 5 yrs of age
Measured: Average timeframe: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startMay 2002
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IntussusceptionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177839
- Sponsor's protocol ID
- 999910/193
- Status last verified
- Nov 2012
- First submitted
- 6 Aug 2010
- Last updated
- 22 Nov 2012
- Results posted
- No
Publications
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.
PubMed 24103115
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Hospital-based, Multicentre Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore
- ClinicalTrials.gov ID
- NCT01177839
- Acronym / sponsor ID
- 999910/193
- Conditions
- Intussusception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study aims to estimate the incidence of intussusception among children < 2 years old through hospital-based surveillance in Singapore.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intussusception cohort | – | Other: Screening sheetsSubjects with Intussusception |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening sheetsReviewing screening sheets | Other | Intussusception cohort |
Primary outcome
Occurrence of definite, probable and possible IS cases in children < 5 yrs of age
Time frame: Average timeframe: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2012.
- Derived from this study: PubMed 24103115Phua 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intussusception, run by GlaxoSmithKline at 5 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of definite, probable and possible IS cases in children < 5 yrs of age (time frame: Average timeframe: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01177839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2012.