Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program
1 other identifier
interventional
30
1 country
1
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 compared to families provided a safe sleep pamphlet and information on how to obtain a free box in the community.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
January 2, 2018
CompletedFirst Posted
Study publicly available on registry
January 8, 2018
CompletedStudy Start
First participant enrolled
January 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedNovember 21, 2018
January 1, 2018
8 months
January 2, 2018
November 20, 2018
Conditions
Outcome Measures
Primary Outcomes (6)
Box ownership
Parents with a baby box
2 months
Usual sleep location
crib, cradle, bassinet, box, other
2 months
Baby box use for sleep
always/sometimes/never/not applicable
2 months
Usual sleep position
supine, other
2 months
Usual infant clothing for sleep
sleeper, sack, swaddled
2 months
Usual bedding
none, tucked blanket, other
2 months
Secondary Outcomes (7)
Safe sleep knowledge
2 months
Current infant feeding
2 months
Household smoking
2 months
Vitamin D
2 months
Immunizations
12 months
- +2 more secondary outcomes
Other Outcomes (2)
Adverse events
2 months
Parent feedback
2 months
Study Arms (2)
Study Box & Education Session
EXPERIMENTALParents are provided a baby box and infant health and safety products and participate in a face to face educational session
Community Box & Online Education
ACTIVE COMPARATORParents are informed how to receive a free box from a community site and are provided a guide to online resources for prenatal and infant health promotion
Interventions
Face to face education and baby box orientation session
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manitobalead
- Canadian Paediatric Societycollaborator
- Manitoba Health, Seniors and Active Livingcollaborator
Study Sites (1)
University of Manitoba
Winnipeg, Manitoba, R3E 3P5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan Nickel, PhD
University of Manitoba
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2018
First Posted
January 8, 2018
Study Start
January 22, 2018
Primary Completion
September 30, 2018
Study Completion
September 30, 2018
Last Updated
November 21, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share