A short co-designed video to help parents decide about neonatal research participation
Official title: Examining the Efficacy of a Parent-targeted Co-designed Digital Media Intervention to Increase Recruitment Rates Across a Multi-site Randomized Clinical Trial in Canadian NICU's
Run by IWK Health Centre · NCT07284329 · Data updated 2026-11-12
This project will test whether adding a short, co-designed digital video helps parents of very premature infants in Canadian NICUs understand and feel comfortable joining the WHEAT feeding study.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 30 Weeks |
| Sex | All |
| Enrollment | 787 (estimated) |
| Sponsor | IWK Health Centre Academic / other |
| Locations | 15 sites (Edmonton, Alberta and 14 other locations) |
| Status | Recruiting |
| Started | January 6, 2025 |
| Main results expected | April 15, 2026 |
| Study ends | April 30, 2026 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT07284329 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Parents or primary caregivers of infants born before 30 weeks gestation who are admitted to one of the participating Canadian NICUs and are approached for the WHEAT International Trial while the SWAT is active are ideal candidates.
✕Probably not a fit
Families who are not approached for WHEAT, whose infants are ineligible for the parent trial, who face unaddressed language barriers, or who are too medically or emotionally unstable at the time of approach may not benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
WHEAT-Boost is a stepped-wedge cluster randomized embedded study within the WHEAT International Trial that sequentially introduces a 3.5–4 minute co-designed digital video across participating Canadian NICUs. Fifteen sites begin with usual recruitment materials and transition to the intervention at randomized 29-day intervals, with each site serving as its own control. The video, accessible via QR code on a secure website and created with parent partners, uses plain language and visuals to explain neonatal research and key details of the WHEAT Trial. Primary outcomes include recruitment rates, parental comprehension, and satisfaction with the consent process in the NICU setting.
Why it matters
Potential benefit: If successful, this approach could increase enrollment and help parents make more informed, comfortable decisions about enrolling their very preterm infants in neonatal research.
How similar studies have gone: Previous multimedia and co-designed consent tools in other clinical settings have shown mixed but generally promising improvements in participant understanding and satisfaction, though evidence is limited specifically in NICU-embedded SWATs.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria (applied to infants/participants in WHEAT Trial): Infant meets eligibility criteria for the WHEAT International Trial Infant is \<30 weeks gestational age at birth Infant is admitted to one of the participating Canadian NICU sites Parent(s)/primary caregiver(s) are approached for consent to participate in the WHEAT Trial during a time period when the SWAT is active at their site Exclusion Criteria: Infant or family ineligible for participation in the WHEAT International Trial Parent(s)/primary caregiver(s) not approached for WHEAT Trial participation (e.g., missed recruitment window, language barriers not addressed by materials, medical instability of infant or family)
Where it's running
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Royal Alexandra Hospital
Edmonton, Alberta, Canada Recruiting -
BC Women's Hospital and Health Centre
Vancouver, British Columbia, Canada Recruiting -
Dr. Everett Chalmers
Fredericton, New Brunswick, Canada Recruiting -
Moncton Hospital
Moncton, New Brunswick, Canada Recruiting -
Saint John Regional Hospital
Saint John, New Brunswick, Canada Recruiting -
Janeway Children's Health and Rehabilitation Centre
Saint Johns, Nfld, Canada Recruiting
Show 9 more locations
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IWK Health
Halifax, Nova Scotia, Canada Recruiting -
Kingston Health Sciences Centre
Kingston, Ontario, Canada Recruiting -
London Health Sciences Centre
London, Ontario, Canada Recruiting -
The Ottawa Hospital/CHEO
Ottawa, Ontario, Canada Recruiting -
Mount Sinai
Toronto, Ontario, Canada Recruiting -
Windsor Regional Hospital
Windsor, Ontario, Canada Recruiting -
Centre hospitalier de l'Université Laval
Laval, Quebec, Canada Recruiting -
Montreal Children's Hospital
Montreal, Quebec, Canada Recruiting -
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Balpreet Singh — IWK Health
- Study coordinator: Cari-Lee Carnell
- Email: cari-lee.carnell@iwk.nshealth.ca
- Phone: 902-219-2216
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.