Consent ProcessWHEAT-BoostNCT07284329
Examining the Efficacy of a Digital Media Intervention to Increase Recruitment Rates
A study testing Intervention (Video) Arm in people with Consent Process, run by IWK Health Centre at 15 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 30 weeks
- Conditions the study is for
- Consent Process
- What is being tested?
- Intervention (Video) Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 787 participants
- Where
- 15 sitesCanada
- Study dates
- 6 Jan 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Canada15 sites, 15 recruiting
- Recruiting
Royal Alexandra Hospital
Edmonton, Alberta
- Recruiting
Dr. Everett Chalmers
Fredericton, New Brunswick
- Recruiting
IWK Health
Halifax, Nova Scotia
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario
- Recruiting
Centre hospitalier de l'Université Laval
Laval, Quebec
- Recruiting
London Health Sciences Centre
London, Ontario
- Recruiting
Moncton Hospital
Moncton, New Brunswick
- Recruiting
Montreal Children's Hospital
Montreal, Quebec
- Recruiting
The Ottawa Hospital/CHEO
Ottawa, Ontario
- Recruiting
Saint John Regional Hospital
Saint John, New Brunswick
- Recruiting
Janeway Children's Health and Rehabilitation Centre
Saint Johns, NFLD
- Recruiting
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec
- Recruiting
Mount Sinai
Toronto, Ontario
- Recruiting
BC Women's Hospital and Health Centre
Vancouver, British Columbia
- Recruiting
Windsor Regional Hospital
Windsor, Ontario
About this study
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
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.
Read more
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.
Read the detailed 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.
- Conditions
- Consent Process
- Being tested
- Intervention (Video) Arm
- Keywords
- Consent, Neonatal research, Family questionnaires, Digital media, Co-design, Study video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention (Video) ArmBehavioural
A 3.5-4-minute co-designed digital media video created to supplement the standard consent process for the WHEAT International Trial.
| Study group | Role | What they receive |
|---|---|---|
| Control (No-Video) Arm | No intervention | Participants receive the standard informed consent or opt-out consent documentation for the WHEAT International Trial without any additional digital media support. Research staff approach parents/primary caregivers using the usual verbal and paper-based consent process. Families then complete a brief questionnaire about their understanding and experience with the consent process. |
| Intervention (Video) Arm | Experimental | Participants receive the usual informed consent or opt-out consent documentation plus access to a co-designed 3.5-4-minute digital media video that explains the importance of neonatal research and key trial details in an accessible format. The video is intended to supplement and clarify the consent process to improve understanding and recruitment.
Research staff provide parents/primary caregivers with a QR code linking to the video hosted on the WHEAT International Trial website. Families are encouraged to watch the video on their personal devices or hospital devices if needed. This is provided alongside the usual consent documentation during the NICU stay. Following this, families complete the same brief questionnaire about their experience and comprehension. Receives: Behavioral: Intervention (Video) Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opt-in Rate for the WHEAT International Trial
The proportion of families approached for participation in the WHEAT International Trial who provide consent (or do not opt out, depending on the site's consent model) for their infant to be enrolled.
Measured: Baseline (When the family is approached for the Study Participation - Within first two weeks of life))
Secondary outcomes (3)
Trial Withdrawal Rate (Post-Randomization)
The proportion of enrolled participants who withdraw from the WHEAT International Trial after randomization.
Measured: Birth to 40 weeks Post Menstrual Age (From enrollment until study completion)
Parental Comprehension of Trial-Specific Details
Degree to which parents understand key elements of the WHEAT International Trial, assessed via a brief questionnaire co-designed with a parent-partner group.
Measured: Baseline (Once family makes the consent decision - Within first two weeks of life)
Parental Experience with the Consent Process
Parents' perceptions of the clarity, helpfulness, and adequacy of the information provided during the consent process, collected via a brief, co-designed questionnaire.
Measured: Baseline (Once family makes the consent decision - Within first two weeks of life)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start6 Jan 2025
- Primary completion15 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Consent ProcessStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a stepped-wedge cluster randomized design, where participating NICU sites transition sequentially from the control (usual consent process) to the intervention (usual process plus digital media video) at randomized time points. Individual participants are exposed to only one condition based on the timing of their enrollment, making the study function as a parallel assignment design at the participant level.
- Masking
- None (open label)
- Enrolment
- 787 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Balpreet Singh, IWK Health Centre
- Investigators
- Balpreet Singh, Principal investigator, IWK Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284329
- Sponsor's protocol ID
- 1027137 (SWAT)
- Other IDs
- CTR-184893/ CT1-184892
- Acronym
- WHEAT-Boost
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lawrence LM, Bishop A, Curran J. Integrated Knowledge Translation with Public Health Policy Makers: A Scoping Review. Healthc Policy. 2019 Feb;14(3):55-77. doi: 10.12927/hcpol.2019.25792.
PubMed 31017866Korstjens I, Moser A. Series: Practical guidance to qualitative research. Part 4: Trustworthiness and publishing. Eur J Gen Pract. 2018 Dec;24(1):120-124. doi: 10.1080/13814788.2017.1375092. Epub 2017 Dec 5.
PubMed 29202616Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x.
PubMed 18352969Ouyang Y, Karim ME, Gustafson P, Field TS, Wong H. Explaining the variation in the attained power of a stepped-wedge trial with unequal cluster sizes. BMC Med Res Methodol. 2020 Jun 24;20(1):166. doi: 10.1186/s12874-020-01036-5.
PubMed 32580698Voldal EC, Hakhu NR, Xia F, Heagerty PJ, Hughes JP. swCRTdesign: An RPackage for Stepped Wedge Trial Design and Analysis. Comput Methods Programs Biomed. 2020 Nov;196:105514. doi: 10.1016/j.cmpb.2020.105514. Epub 2020 May 21.
PubMed 32554025Synnot A, Ryan R, Prictor M, Fetherstonhaugh D, Parker B. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database Syst Rev. 2014 May 9;2014(5):CD003717. doi: 10.1002/14651858.CD003717.pub3.
PubMed 24809816Ballard HO, Shook LA, Desai NS, Anand KJ. Neonatal research and the validity of informed consent obtained in the perinatal period. J Perinatol. 2004 Jul;24(7):409-15. doi: 10.1038/sj.jp.7211142.
PubMed 15152271Wilman E, Megone C, Oliver S, Duley L, Gyte G, Wright JM. The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research. Trials. 2015 Nov 4;16:502. doi: 10.1186/s13063-015-0957-x.
PubMed 26537492Dahav P, Sjostrom-Strand A. Parents' experiences of their child being admitted to a paediatric intensive care unit: a qualitative study-like being in another world. Scand J Caring Sci. 2018 Mar;32(1):363-370. doi: 10.1111/scs.12470. Epub 2017 Aug 22.
PubMed 28833379Obeidat HM, Bond EA, Callister LC. The parental experience of having an infant in the newborn intensive care unit. J Perinat Educ. 2009 Summer;18(3):23-9. doi: 10.1624/105812409X461199.
PubMed 20514124Al Maghaireh DF, Abdullah KL, Chan CM, Piaw CY, Al Kawafha MM. Systematic review of qualitative studies exploring parental experiences in the Neonatal Intensive Care Unit. J Clin Nurs. 2016 Oct;25(19-20):2745-56. doi: 10.1111/jocn.13259. Epub 2016 Jun 3.
PubMed 27256250
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07284329
- Acronym / sponsor ID
- WHEAT-Boost / 1027137 (SWAT)
- Conditions
- Consent Process
- Keywords
- Consent, Neonatal research, Family questionnaires, Digital media, Co-design, Study video
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 787 participants (estimated)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 16 Dec 2025 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a stepped-wedge cluster randomized design, where participating NICU sites transition sequentially from the control (usual consent process) to the intervention (usual process plus digital media video) at randomized time points. Individual participants are exposed to only one condition based on the timing of their enrollment, making the study function as a parallel assignment design at the participant level.
| Arm | Type | Receives |
|---|---|---|
| Control (No-Video) Arm | No intervention | –Participants receive the standard informed consent or opt-out consent documentation for the WHEAT International Trial without any additional digital media support. Research staff approach parents/primary caregivers using the usual verbal and paper-based consent process. Families then complete a brief questionnaire about their understanding and experience with the consent process. |
| Intervention (Video) Arm | Experimental | Behavioral: Intervention (Video) ArmParticipants receive the usual informed consent or opt-out consent documentation plus access to a co-designed 3.5-4-minute digital media video that explains the importance of neonatal research and key trial details in an accessible format. The video is intended to supplement and clarify the consent process to improve understanding and recruitment. Research staff provide parents/primary caregivers with a QR code linking to the video hosted on the WHEAT International Trial website. Families are encouraged to watch the video on their personal devices or hospital devices if needed. This is provided alongside the usual consent documentation during the NICU stay. Following this, families complete the same brief questionnaire about their experience and comprehension. |
Who may qualify
- Ages
- Up to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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)
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 |
|---|---|---|
| Intervention (Video) ArmA 3.5-4-minute co-designed digital media video created to supplement the standard consent process for the WHEAT International Trial. | Behavioural | Intervention (Video) Arm |
Primary outcome
Opt-in Rate for the WHEAT International Trial
Time frame: Baseline (When the family is approached for the Study Participation - Within first two weeks of life))
The proportion of families approached for participation in the WHEAT International Trial who provide consent (or do not opt out, depending on the site's consent model) for their infant to be enrolled.
3 secondary outcomes
Trial Withdrawal Rate (Post-Randomization)
Time frame: Birth to 40 weeks Post Menstrual Age (From enrollment until study completion)
Parental Comprehension of Trial-Specific Details
Time frame: Baseline (Once family makes the consent decision - Within first two weeks of life)
Parental Experience with the Consent Process
Time frame: Baseline (Once family makes the consent decision - Within first two weeks of life)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 31017866Lawrence LM, Bishop A, Curran J. Integrated Knowledge Translation with Public Health Policy Makers: A Scoping Review. Healthc Policy. 2019 Feb;14(3):55-77. doi: 10.12927/hcpol.2019.25792.
- Background: PubMed 29202616Korstjens I, Moser A. Series: Practical guidance to qualitative research. Part 4: Trustworthiness and publishing. Eur J Gen Pract. 2018 Dec;24(1):120-124. doi: 10.1080/13814788.2017.1375092. Epub 2017 Dec 5.
- Background: PubMed 18352969Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x.
- Background: PubMed 32580698Ouyang Y, Karim ME, Gustafson P, Field TS, Wong H. Explaining the variation in the attained power of a stepped-wedge trial with unequal cluster sizes. BMC Med Res Methodol. 2020 Jun 24;20(1):166. doi: 10.1186/s12874-020-01036-5.
- Background: PubMed 32554025Voldal EC, Hakhu NR, Xia F, Heagerty PJ, Hughes JP. swCRTdesign: An RPackage for Stepped Wedge Trial Design and Analysis. Comput Methods Programs Biomed. 2020 Nov;196:105514. doi: 10.1016/j.cmpb.2020.105514. Epub 2020 May 21.
- Background: PubMed 24809816Synnot A, Ryan R, Prictor M, Fetherstonhaugh D, Parker B. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database Syst Rev. 2014 May 9;2014(5):CD003717. doi: 10.1002/14651858.CD003717.pub3.
- Background: PubMed 15152271Ballard HO, Shook LA, Desai NS, Anand KJ. Neonatal research and the validity of informed consent obtained in the perinatal period. J Perinatol. 2004 Jul;24(7):409-15. doi: 10.1038/sj.jp.7211142.
- Background: PubMed 26537492Wilman E, Megone C, Oliver S, Duley L, Gyte G, Wright JM. The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research. Trials. 2015 Nov 4;16:502. doi: 10.1186/s13063-015-0957-x.
- Background: PubMed 28833379Dahav P, Sjostrom-Strand A. Parents' experiences of their child being admitted to a paediatric intensive care unit: a qualitative study-like being in another world. Scand J Caring Sci. 2018 Mar;32(1):363-370. doi: 10.1111/scs.12470. Epub 2017 Aug 22.
- Background: PubMed 20514124Obeidat HM, Bond EA, Callister LC. The parental experience of having an infant in the newborn intensive care unit. J Perinat Educ. 2009 Summer;18(3):23-9. doi: 10.1624/105812409X461199.
- Background: PubMed 27256250Al Maghaireh DF, Abdullah KL, Chan CM, Piaw CY, Al Kawafha MM. Systematic review of qualitative studies exploring parental experiences in the Neonatal Intensive Care Unit. J Clin Nurs. 2016 Oct;25(19-20):2745-56. doi: 10.1111/jocn.13259. Epub 2016 Jun 3.
- Individual participant dataSharing planned: Undecided
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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.
Balpreet Singh principal investigator
IWK Health
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention (Video) Arm in people with Consent Process, run by IWK Health Centre at 15 sites 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 0 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cari-Lee Carnell (902-219-2216, cari-lee.carnell@iwk.nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opt-in Rate for the WHEAT International Trial (time frame: Baseline (When the family is approached for the Study Participation - Within first two weeks of life))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07284329, which also lists 11 linked publications.
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 16 Dec 2025.