Overview
WHEAT-Boost is a Study Within A Trial (SWAT) that aims to improve how families are recruited into neonatal research studies by testing a new way of sharing information. The study is embedded within the larger WHEAT International Trial, a randomized clinical trial being conducted in Neonatal Intensive Care Units (NICUs) across Canada. The WHEAT International Trial investigates the best way to manage feeding around the time of blood transfusions in very premature infants (born before 30 weeks of pregnancy).
Recruiting families for research in the NICU is challenging. Parents are often stressed, overwhelmed, and unfamiliar with how clinical trials work, which can make it hard for them to process complex medical information and decide whether to take part. Traditional consent methods, such as paper forms, may not be enough to ensure families feel informed and comfortable with participation.
To address this, WHEAT-Boost will test whether adding a short, co-designed digital video helps improve recruitment rates. The video is 3.5 to 4 minutes long, available in English and French (with subtitles in other commonly spoken languages), and explains the importance of NICU research and details of the WHEAT International Trial in a simple and visual way. The video was co-developed with parents who have experience in the NICU to ensure the information is relevant and easy to understand.
NICU sites participating in the WHEAT Trial will be randomly assigned, in a stepped-wedge design schedule, to either continue using their usual recruitment methods, or to add the digital video to their recruitment approach. Parents in both groups will be asked to complete a short, voluntary questionnaire about their experience with the consent process and their understanding of the trial.
The main goal of WHEAT-Boost is to see if the video increases the number of families who agree to take part in the WHEAT Trial (known as the "opt-in rate"). The study will also look at whether the video reduces the number of families who later withdraw from the trial, and whether it improves parents' understanding of the study and their satisfaction with how information was shared.
If successful, the video could be used in other NICUs or future studies to help make research more accessible and inclusive for families. This approach could lead to stronger participation in neonatal trials, better-informed decisions by parents, and faster progress in improving care for premature babies.
Description
WHEAT-Boost is a stepped-wedge cluster randomized SWAT embedded within the ongoing WHEAT International Trial (NCT05213806), which evaluates feeding practices around blood transfusion in preterm infants. The SWAT aims to examine whether the addition of a co-designed digital media intervention improves recruitment outcomes, parental comprehension, and satisfaction with the research consent process in the NICU setting.
Fifteen Canadian NICUs participating in the WHEAT International Trial will be randomized in a stepped-wedge design to transition from the control condition (usual recruitment approach) to the intervention condition (usual approach plus video). Each site will act as its own control, with transitions occurring at 29-day intervals. All sites will begin in the control arm, using standard informed or opt-out consent materials, and then sequentially implement the video intervention according to the randomized schedule.
The intervention consists of a 3.5- to 4-minute digital video co-developed with a parent-partner advisory group. The video uses accessible language, storytelling, and visual elements to highlight the role and value of neonatal research and to clarify key details of the WHEAT Trial. It is delivered via a QR code linked to a secure website, enabling families to view the content on personal or institutional devices. The co-design approach ensures the material is tailored to the needs and concerns of NICU families, many of whom may experience emotional distress and information overload during their infant's hospitalization.
This SWAT will evaluate several outcomes. The primary outcome is the WHEAT Trial opt-in rate, defined as the proportion of eligible families who consent to enroll their infant in the trial. Secondary outcomes include the post-randomization withdrawal rate, parental comprehension of trial-specific information, and overall experience with the consent process. These will be measured using a brief questionnaire co-designed with the parent group and administered to all approached families, regardless of group assignment.
Analysis of the primary and secondary outcomes will follow intention-to-treat principles and will use generalized linear mixed models appropriate for the stepped-wedge design. Models will include random intercepts for sites and fixed effects for time and intervention status. For qualitative data from open-ended survey responses, an inductive thematic analysis approach will be applied.
This SWAT addresses a critical need for evidence-based strategies to enhance trial recruitment in high-stress clinical environments like the NICU. By supplementing conventional consent procedures with engaging, accessible media, the study seeks to normalize research participation and support informed decision-making by parents of vulnerable infants. If effective, this low-cost, scalable intervention could be readily adapted to other trials and clinical settings, advancing broader efforts to improve inclusivity and transparency in neonatal research.
Eligibility
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)