An interventional study of Study Box and Community Box in Sudden Infant Death, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged Up to 2 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-21.
Sponsored by University of Manitoba · Not applicable, Interventional, and Prevention
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Among 12 studies in Sudden Infant Death with a site in Canada — 1 open to participants now, 3 under way, 2 of them phase 3. Sudden Infant Death · Canada.
Among the 12 studies in Sudden Infant Death with a site in Canada, this one is the only one that started in 2018, is the only one with no phase, and was the 6th registered.
80 studies on the registry are indexed under Sudden Infant Death; 14 are open to participants now.
Browse Sudden Infant Death studies →1 of the 12 studies in Sudden Infant Death with a site in Canada is open now. Recruiting first, the newest first:
Denali Therapeutics Inc. · Sites in Canada, United States, Argentina and 11 more countries
Ages up to 18
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 9 Sudden Infant Death studies recruiting now, 4 set no upper age limit and 5 stop at 75 or younger; 7 take children under 18; 2 take healthy volunteers.
This study: Up to 2 Months · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 7 · Phase 3 4
First in 2004; this study’s year is marked. 1 started in 2018.
This study's enrollment of 30 is below the median of 60 across 51 interventional studies indexed under Sudden Infant Death.
Median enrollment 47 across the 9 interventional studies, 100 across the 3 observational. Of the 7 that completed or were terminated, 3 (43%) have results posted.
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10 of 12 have an industry lead sponsor. The 7 most frequent:
University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
University of Manitoba has 1 study filed under Sudden Infant Death — fewer than ten, so there is no comparison to draw.
1 of the studies in Sudden Infant Death with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06075537Phase 3Denali Therapeutics Inc.An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007 | 2027-06 |
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Among the 12 studies in Sudden Infant Death with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Parents are provided a baby box and infant health and safety products and participate in a face to face educational session
Device: Study Box · Behavioral: Education 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
Device: Community Box · Behavioral: Online Education
Baby box (bassinet) with infant items
Baby box (bassinet)
Face to face education and baby box orientation session
Online baby box education
Box ownership
Parents with a baby box
Time frame: 2 months
Usual sleep location
crib, cradle, bassinet, box, other
Time frame: 2 months
Baby box use for sleep
always/sometimes/never/not applicable
Time frame: 2 months
Usual sleep position
supine, other
Time frame: 2 months
Usual infant clothing for sleep
sleeper, sack, swaddled
Time frame: 2 months
Usual bedding
none, tucked blanket, other
Time frame: 2 months
Safe sleep knowledge
safe sleep location, position, infant clothing, bedding (1 point each)
Time frame: 2 months
Current infant feeding
breastfeeding, formula feeding, both
Time frame: 2 months
Household smoking
total number of cigarettes smoked per day in the household
Time frame: 2 months
Vitamin D
Infant provided daily dose of Vitamin D (always/sometimes/never)
Time frame: 2 months
Immunizations
Number of infant immunizations in the first year of life
Time frame: 12 months
Prenatal visits
Number of prenatal visits
Time frame: 9 months
Infant hospitalizations
Infant hospitalizations in the first year of life (number of hospitalizations, total hospital days, respiratory vs. non-respiratory hospital days)
Time frame: 12 months
Adverse events
Parent-reported adverse events and concerns regarding the baby box
Time frame: 2 months
Parent feedback
Parent-reported opinions and preferences (likes/dislikes) regarding the baby box and the distribution process
Time frame: 2 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Sep 2018, 8 months.
Of 15 interventional studies with no phase under Sudden Infant Death, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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