Last updated: 11/04/2018 04:17:10
Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Prospective, Hospital-based, Multicentre Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore
Trial description: This prospective study aims to estimate the incidence of intussusception among children < 2 years old through hospital-based surveillance in Singapore.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of definite, probable and possible IS cases in children < 5 yrs of age
Timeframe: Average timeframe: one year
Secondary outcomes:
Not applicable
Interventions:
Other: Screening sheets
Enrollment:
178
Observational study model:
Case-Only
Primary completion date:
2010-31-07
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Intussusception
Product
SB444563
Collaborators
Not applicable
Study date(s)
May 2002 to July 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable N/A - 24 months
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
A male or female infant aged < 24months at the time of diagnosis of intussusception.
Exclusion criteria:
- The subject has had a radiographically or surgically confirmed case of intussusception prior to the current episode.
A male or female infant ≥ 24 months of age at the time of intussusception diagnosis.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2010-31-07
Actual study completion date
2010-31-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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