Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program
Primary Purpose
Sudden Infant Death
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Study Box
Community Box
Education Session
Online Education
Sponsored by
About this trial
This is an interventional prevention trial for Sudden Infant Death
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
Sites / Locations
- University of Manitoba
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study Box & Education Session
Community Box & Online Education
Arm Description
Parents are provided a baby box and infant health and safety products and participate in a face to face educational session
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
Outcomes
Primary Outcome Measures
Box ownership
Parents with a baby box
Usual sleep location
crib, cradle, bassinet, box, other
Baby box use for sleep
always/sometimes/never/not applicable
Usual sleep position
supine, other
Usual infant clothing for sleep
sleeper, sack, swaddled
Usual bedding
none, tucked blanket, other
Secondary Outcome Measures
Safe sleep knowledge
safe sleep location, position, infant clothing, bedding (1 point each)
Current infant feeding
breastfeeding, formula feeding, both
Household smoking
total number of cigarettes smoked per day in the household
Vitamin D
Infant provided daily dose of Vitamin D (always/sometimes/never)
Immunizations
Number of infant immunizations in the first year of life
Prenatal visits
Number of prenatal visits
Infant hospitalizations
Infant hospitalizations in the first year of life (number of hospitalizations, total hospital days, respiratory vs. non-respiratory hospital days)
Full Information
NCT ID
NCT03392727
First Posted
January 2, 2018
Last Updated
November 20, 2018
Sponsor
University of Manitoba
Collaborators
Canadian Paediatric Society, Manitoba Health, Seniors and Active Living
1. Study Identification
Unique Protocol Identification Number
NCT03392727
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
Collaborators
Canadian Paediatric Society, Manitoba Health, Seniors and Active Living
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Infant Death
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Box & Education Session
Arm Type
Experimental
Arm Description
Parents are provided a baby box and infant health and safety products and participate in a face to face educational session
Arm Title
Community Box & Online Education
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Study Box
Intervention Description
Baby box (bassinet) with infant items
Intervention Type
Device
Intervention Name(s)
Community Box
Intervention Description
Baby box (bassinet)
Intervention Type
Behavioral
Intervention Name(s)
Education Session
Intervention Description
Face to face education and baby box orientation session
Intervention Type
Behavioral
Intervention Name(s)
Online Education
Intervention Description
Online baby box education
Primary Outcome Measure Information:
Title
Box ownership
Description
Parents with a baby box
Time Frame
2 months
Title
Usual sleep location
Description
crib, cradle, bassinet, box, other
Time Frame
2 months
Title
Baby box use for sleep
Description
always/sometimes/never/not applicable
Time Frame
2 months
Title
Usual sleep position
Description
supine, other
Time Frame
2 months
Title
Usual infant clothing for sleep
Description
sleeper, sack, swaddled
Time Frame
2 months
Title
Usual bedding
Description
none, tucked blanket, other
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Safe sleep knowledge
Description
safe sleep location, position, infant clothing, bedding (1 point each)
Time Frame
2 months
Title
Current infant feeding
Description
breastfeeding, formula feeding, both
Time Frame
2 months
Title
Household smoking
Description
total number of cigarettes smoked per day in the household
Time Frame
2 months
Title
Vitamin D
Description
Infant provided daily dose of Vitamin D (always/sometimes/never)
Time Frame
2 months
Title
Immunizations
Description
Number of infant immunizations in the first year of life
Time Frame
12 months
Title
Prenatal visits
Description
Number of prenatal visits
Time Frame
9 months
Title
Infant hospitalizations
Description
Infant hospitalizations in the first year of life (number of hospitalizations, total hospital days, respiratory vs. non-respiratory hospital days)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Parent-reported adverse events and concerns regarding the baby box
Time Frame
2 months
Title
Parent feedback
Description
Parent-reported opinions and preferences (likes/dislikes) regarding the baby box and the distribution process
Time Frame
2 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Nickel, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program
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