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

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.

Study Overview

• Status: Completed
• Conditions: Sudden Infant Death
• Intervention / Treatment: Device: Study Box; Behavioral: Education Session; Device: Community Box; Behavioral: Online Education

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P5
      • University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Parent-reported adverse events and concerns regarding the baby box	2 months
Parent feedback	Parent-reported opinions and preferences (likes/dislikes) regarding the baby box and the distribution process	2 months

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Canadian Paediatric Society; Manitoba Health, Seniors and Active Living
• Investigators: Principal Investigator: Nathan Nickel, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): November 21, 2018
• Last Update Submitted That Met QC Criteria: November 20, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Death, Sudden; Death; Infant Death; Sudden Infant Death
• Other Study ID Numbers: H2017:390

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No