Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program
- Conditions
- Sudden Infant Death
- Interventions
- Device: Study BoxDevice: Community BoxBehavioral: Education SessionBehavioral: Online Education
- Registration Number
- NCT03392727
- Lead Sponsor
- University of Manitoba
- 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.
- 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, safe sleep, and infant health promotion; the control group (n=110) will be provided information on how to obtain the same baby box at a community site in Winnipeg, and will receive a safe sleep pamphlet, baby box pamphlet and a guide to online resources for prenatal ad infant health promotion. An additional comparison group will be parents who already have a baby box at the time of recruitment. This group will also receive the safe sleep pamphlet. Families will be interviewed at recruitment and 2-4 months of age to measure box ownership and self-reported safe sleep and infant health promotion practices. Administrative data will be used to evaluate the impact on infant immunizations and hospitalizations in the first year of life, and to evaluate the impacts of prenatal care visits and neonatal length of stay on the outcomes.
Families will be asked to participate in a face to face interview at baseline (enrolment) and one follow-up interview coordinated with a scheduled routine healthcare visit for the infant at 2 months of age and conducted face to face or by telephone, according to family preference.
PHIN will be requested for both mother and infant in order to explore the relationship between adequacy of prenatal care and the study outcomes, and to evaluate the impact on infant immunizations and hospitalizations in the first year of life. Postal code will be requested to analyze differences related to place of residence and neighbourhood income quintile.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Box & Education Session Education Session Parents are provided a baby box and infant health and safety products and participate in a face to face educational session Study Box & Education Session Study Box Parents are provided a baby box and infant health and safety products and participate in a face to face educational session Community Box & Online Education Online Education Parents 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 Community Box & Online Education Community Box Parents 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
- Primary Outcome Measures
Name Time Method Usual sleep position 2 months supine, other
Usual sleep location 2 months crib, cradle, bassinet, box, other
Baby box use for sleep 2 months always/sometimes/never/not applicable
Box ownership 2 months Parents with a baby box
Usual infant clothing for sleep 2 months sleeper, sack, swaddled
Usual bedding 2 months none, tucked blanket, other
- Secondary Outcome Measures
Name Time Method Infant hospitalizations 12 months Infant hospitalizations in the first year of life (number of hospitalizations, total hospital days, respiratory vs. non-respiratory hospital days)
Current infant feeding 2 months breastfeeding, formula feeding, both
Safe sleep knowledge 2 months safe sleep location, position, infant clothing, bedding (1 point each)
Vitamin D 2 months Infant provided daily dose of Vitamin D (always/sometimes/never)
Prenatal visits 9 months Number of prenatal visits
Household smoking 2 months total number of cigarettes smoked per day in the household
Immunizations 12 months Number of infant immunizations in the first year of life
Trial Locations
- Locations (1)
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada