Sudden Infant Death Clinical Trial
Official title:
Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program
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.
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.
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