NCT03392727

Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 2 Months
• Healthy volunteers: Accepted

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.

Conditions

• Sudden Infant Death

Interventions

Type	Name	Description
DEVICE	Study Box	Baby box (bassinet) with infant items
DEVICE	Community Box	Baby box (bassinet)
BEHAVIORAL	Education Session	Face to face education and baby box orientation session
BEHAVIORAL	Online Education	Online baby box education

Timeline

• Start date: 2018-01-22
• Primary completion: 2018-09-30
• Completion: 2018-09-30
• First posted: 2018-01-08
• Last updated: 2018-11-21

Locations

1 site across 1 country: Canada