Status:
COMPLETED
Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Canadian Paediatric Society
Manitoba Health, Seniors and Active Living
Conditions:
Sudden Infant Death
Eligibility:
All Genders
Up to 2 years
Phase:
NA
Brief Summary
This study will evaluate baby box ownership and safe sleep practices (sleep location, sleep position, use of bedding) among families provided a free baby box and standardized safe sleep education comp...
Detailed Description
The proposed study is a randomized controlled trial with two arms: the intervention group (n=110) will be provided a baby box and standardized face to face education regarding the box and its contents...
Eligibility Criteria
Inclusion
- Mothers who are 32 weeks or more gestation
- Infants less than 3 months of age (or post-conceptional age 44 weeks)
- Able to consent freely and complete face to face and/or telephone interviews in English
- Will be residing in Winnipeg until the infant is 2-4 months of age or able to complete a telephone interview at 2-4 months of age
Exclusion
- Parent/guardian/client less than 18 years of age (unless emancipated minor)
- Parents who cannot consent due to intellectual capacity, medical condition, etc.
- Infant is discharged from hospital in the care of Child and Family Services or a birth alert is in place
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03392727
Start Date
January 22 2018
End Date
September 30 2018
Last Update
November 21 2018
Active Locations (1)
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1
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 3P5