Sudden Infant DeathNCT03392727
Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program
A study testing Study Box, Community Box and Education Session in people with Sudden Infant Death, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Sudden Infant Death
- What is being tested?
- Study Box, Community Box and Education Session
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jan 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sudden Infant Death
- Being tested
- Study Box, Community Box, Education Session, Online Education
- Medical subject headings
- Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study BoxDevice
Baby box (bassinet) with infant items
Community BoxDevice
Baby box (bassinet)
Education SessionBehavioural
Face to face education and baby box orientation session
Online EducationBehavioural
Online baby box education
| Study group | Role | What they receive |
|---|---|---|
| Study Box & Education Session | Experimental | Parents are provided a baby box and infant health and safety products and participate in a face to face educational session Receives: Device: Study Box; Behavioral: Education Session |
| Community Box & Online Education | Active comparator | 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 Receives: Device: Community Box; Behavioral: Online Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box ownership
Parents with a baby box
Measured: 2 months
Usual sleep location
crib, cradle, bassinet, box, other
Measured: 2 months
Baby box use for sleep
always/sometimes/never/not applicable
Measured: 2 months
Usual sleep position
supine, other
Measured: 2 months
Usual infant clothing for sleep
sleeper, sack, swaddled
Measured: 2 months
Usual bedding
none, tucked blanket, other
Measured: 2 months
Secondary outcomes (7)
Safe sleep knowledge
safe sleep location, position, infant clothing, bedding (1 point each)
Measured: 2 months
Current infant feeding
breastfeeding, formula feeding, both
Measured: 2 months
Household smoking
total number of cigarettes smoked per day in the household
Measured: 2 months
Vitamin D
Infant provided daily dose of Vitamin D (always/sometimes/never)
Measured: 2 months
Immunizations
Number of infant immunizations in the first year of life
Measured: 12 months
Prenatal visits
Number of prenatal visits
Measured: 9 months
Infant hospitalizations
Infant hospitalizations in the first year of life (number of hospitalizations, total hospital days, respiratory vs. non-respiratory hospital days)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start22 Jan 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Infant DeathStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Paediatric Society, Manitoba Health, Seniors and Active Living
- Responsible party
- Sponsor
- Investigators
- Nathan Nickel, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392727
- Sponsor's protocol ID
- H2017:390
- Status last verified
- Jan 2018
- First submitted
- 2 Jan 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program
- ClinicalTrials.gov ID
- NCT03392727
- Acronym / sponsor ID
- H2017:390
- Conditions
- Sudden Infant Death
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Paediatric Society, Manitoba Health, Seniors and Active Living
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Box & Education Session | Experimental | Device: Study Box, Behavioral: Education SessionParents are provided a baby box and infant health and safety products and participate in a face to face educational session |
| Community Box & Online Education | Active comparator | Device: Community Box, Behavioral: Online EducationParents 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 |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study BoxBaby box (bassinet) with infant items | Device | Study Box & Education Session |
| Community BoxBaby box (bassinet) | Device | Community Box & Online Education |
| Education SessionFace to face education and baby box orientation session | Behavioural | Study Box & Education Session |
| Online EducationOnline baby box education | Behavioural | Community Box & Online Education |
Primary outcome
Box ownership
Time frame: 2 months
Parents with a baby box
Usual sleep location
Time frame: 2 months
crib, cradle, bassinet, box, other
Baby box use for sleep
Time frame: 2 months
always/sometimes/never/not applicable
Usual sleep position
Time frame: 2 months
supine, other
Usual infant clothing for sleep
Time frame: 2 months
sleeper, sack, swaddled
Usual bedding
Time frame: 2 months
none, tucked blanket, other
7 secondary outcomes
Safe sleep knowledge
Time frame: 2 months
Current infant feeding
Time frame: 2 months
Household smoking
Time frame: 2 months
Vitamin D
Time frame: 2 months
Immunizations
Time frame: 12 months
Prenatal visits
Time frame: 9 months
Infant hospitalizations
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Nickel, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Box, Community Box and Education Session in people with Sudden Infant Death, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box ownership (time frame: 2 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.