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

Sudden Infant Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392727
• Other study ID #: H2017:390
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: January 2018
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant Death
• Sudden Infant Death

Intervention

Device:
• Study Box
Baby box (bassinet) with infant items
• Community Box
Baby box (bassinet)

Behavioral:
• Education Session
Face to face education and baby box orientation session
• Online Education
Online baby box education

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Canadian Paediatric Society, Manitoba Health, Seniors and Active Living

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Parent-reported adverse events and concerns regarding the baby box	2 months
Other	Parent feedback	Parent-reported opinions and preferences (likes/dislikes) regarding the baby box and the distribution process	2 months
Primary	Box ownership	Parents with a baby box	2 months
Primary	Usual sleep location	crib, cradle, bassinet, box, other	2 months
Primary	Baby box use for sleep	always/sometimes/never/not applicable	2 months
Primary	Usual sleep position	supine, other	2 months
Primary	Usual infant clothing for sleep	sleeper, sack, swaddled	2 months
Primary	Usual bedding	none, tucked blanket, other	2 months
Secondary	Safe sleep knowledge	safe sleep location, position, infant clothing, bedding (1 point each)	2 months
Secondary	Current infant feeding	breastfeeding, formula feeding, both	2 months
Secondary	Household smoking	total number of cigarettes smoked per day in the household	2 months
Secondary	Vitamin D	Infant provided daily dose of Vitamin D (always/sometimes/never)	2 months
Secondary	Immunizations	Number of infant immunizations in the first year of life	12 months
Secondary	Prenatal visits	Number of prenatal visits	9 months
Secondary	Infant hospitalizations	Infant hospitalizations in the first year of life (number of hospitalizations, total hospital days, respiratory vs. non-respiratory hospital days)	12 months