CompletedNot Applicable

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

Canada30 participantsStarted 2018-01-22

Plain-language 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.

Who can participate

Age range

2 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Box ownership

Timeframe: 2 months

Usual sleep location

Timeframe: 2 months

Baby box use for sleep

Timeframe: 2 months

Usual sleep position

Timeframe: 2 months

Usual infant clothing for sleep

Timeframe: 2 months

Usual bedding

Timeframe: 2 months

Trial details

NCT IDNCT03392727

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-30

View on ClinicalTrials.gov More Sudden Infant Death trials

Plain-language summary

Who can participate

Age range

2 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.