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

University of Manitoba

Status: Completed

Conditions: Sudden Infant Death

Treatments: Device: Study Box; Behavioral: Education Session; Device: Community Box; Behavioral: Online Education

Study type: Interventional

Funder types: Other

Identifiers

NCT03392727

H2017:390

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: Under 2 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Study Box & Education Session

Experimental group

Description:

Parents are provided a baby box and infant health and safety products and participate in a face to face educational session

Treatment:

Behavioral: Education Session

Device: Study Box

Community Box & Online Education

Active Comparator group

Description:

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

Treatment:

Device: Community Box

Behavioral: Online Education