Sudden Infant Death
Conditions
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.
Interventions
DEVICEStudy Box
Baby box (bassinet) with infant items
DEVICECommunity Box
Baby box (bassinet)
BEHAVIORALEducation Session
Face to face education and baby box orientation session
BEHAVIORALOnline Education
Online baby box education
Sponsors
Canadian Paediatric Society
Manitoba Health, Seniors and Active Living
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usual infant clothing for sleep | 2 months | sleeper, sack, swaddled |
| Usual bedding | 2 months | none, tucked blanket, other |
| Box ownership | 2 months | Parents with a baby box |
| Usual sleep location | 2 months | crib, cradle, bassinet, box, other |
| Baby box use for sleep | 2 months | always/sometimes/never/not applicable |
| Usual sleep position | 2 months | supine, other |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant hospitalizations | 12 months | Infant hospitalizations in the first year of life (number of hospitalizations, total hospital days, respiratory vs. non-respiratory hospital days) |
| Prenatal visits | 9 months | Number of prenatal visits |
| Safe sleep knowledge | 2 months | safe sleep location, position, infant clothing, bedding (1 point each) |
| Current infant feeding | 2 months | breastfeeding, formula feeding, both |
| Household smoking | 2 months | total number of cigarettes smoked per day in the household |
| Vitamin D | 2 months | Infant provided daily dose of Vitamin D (always/sometimes/never) |
| Immunizations | 12 months | Number of infant immunizations in the first year of life |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 2 months | Parent-reported adverse events and concerns regarding the baby box |
| Parent feedback | 2 months | Parent-reported opinions and preferences (likes/dislikes) regarding the baby box and the distribution process |
Countries
Canada
Outcome results
None listed