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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sudden Infant Death

Intervention / Treatment
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* Device: Study Box
* Device: Community Box
* Behavioral: Education Session
* Behavioral: Online Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Box & Education Session<br>Parents are provided a baby box and infant health and safety products and participate in a face to face educational session | Device: Study Box<br>* Baby box (bassinet) with infant items<br>Behavioral: Education Session<br>* Face to face education and baby box orientation session<br>|
| Active Comparator: Community Box & Online Education<br>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 | Device: Community Box<br>* Baby box (bassinet)<br>Behavioral: Online Education<br>* Online baby box education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box ownership | Parents with a baby box | 2 months | 
| Usual sleep location | crib, cradle, bassinet, box, other | 2 months | 
| Baby box use for sleep | always/sometimes/never/not applicable | 2 months | 
| Usual sleep position | supine, other | 2 months | 
| Usual infant clothing for sleep | sleeper, sack, swaddled | 2 months | 
| Usual bedding | none, tucked blanket, other | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safe sleep knowledge | safe sleep location, position, infant clothing, bedding (1 point each) | 2 months | 
| Current infant feeding | breastfeeding, formula feeding, both | 2 months | 
| Household smoking | total number of cigarettes smoked per day in the household | 2 months | 
| Vitamin D | Infant provided daily dose of Vitamin D (always/sometimes/never) | 2 months | 
| Immunizations | Number of infant immunizations in the first year of life | 12 months | 
| Prenatal visits | Number of prenatal visits | 9 months | 
| Infant hospitalizations | Infant hospitalizations in the first year of life (number of hospitalizations, total hospital days, respiratory vs. non-respiratory hospital days) | 12 months |