Clinical trial NCT03392727: Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program
Official title: Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sudden Infant Death
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian Paediatric Society
name: Manitoba Health, Seniors and Active Living
First posted: 2018-01-08
Enrollment: 30
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Box ownership
timeFrame: 2 months
measure: Usual sleep location
timeFrame: 2 months
measure: Baby box use for sleep
timeFrame: 2 months
measure: Usual sleep position
timeFrame: 2 months
measure: Usual infant clothing for sleep
timeFrame: 2 months
measure: Usual bedding
timeFrame: 2 months
Secondary outcomes:
measure: Safe sleep knowledge
timeFrame: 2 months
measure: Current infant feeding
timeFrame: 2 months
measure: Household smoking
timeFrame: 2 months
measure: Vitamin D
timeFrame: 2 months
measure: Immunizations
timeFrame: 12 months
measure: Prenatal visits
timeFrame: 9 months
measure: Infant hospitalizations
timeFrame: 12 months
Other outcomes:
measure: Adverse events
timeFrame: 2 months
measure: Parent feedback
timeFrame: 2 months
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Nathan Nickel, PhD
role: PRINCIPAL_INVESTIGATOR
References: