Using video to help parents understand consent for extremely preterm infants
Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study: A Randomized Controlled Trial
This study tests if using a video can help parents of extremely preterm infants better understand the consent process for a Vitamin D study.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06446492 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial evaluates the effectiveness of video-enhanced consent compared to the traditional consent process for parents of extremely preterm infants. The goal is to determine if the video approach improves parents' understanding and empowers their decision-making regarding participation in the ViDES study, which focuses on Vitamin D supplementation in these vulnerable infants. Parents or legal guardians of eligible infants in the Neonatal Intensive Care Unit at Children's Memorial Hermann hospital will be recruited for this study.
Who should consider this trial
Good fit: Ideal candidates are parents or legal guardians of extremely preterm infants admitted to the Neonatal Intensive Care Unit who are eligible for the ViDES study.
Not a fit: Parents or guardians who are deaf or blind, or who are unable to provide consent for the ViDES study, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better-informed decisions by parents regarding their infants' participation in clinical research.
How similar studies have performed: Other studies have shown promise in using multimedia approaches for informed consent, suggesting this method could be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parents/legal guardians of extremely preterm infants (\<28 weeks gestational age or \<1000 g birth weight) admitted to the Neonatal Intensive Care Unit at Children's Memorial Hermann hospital that qualify for the ViDES study (ViDES study is separately registered as NCT05459298) Exclusion Criteria: * Parents/legal guardians deaf or blind * Parents/legal guardians unable to consent for the VIDES study
Where this trial is running
Houston, Texas
- McGovern Medical School at UTHealth Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Maria del Mar Romero López, MD, MS, PhD — The University of Texas Health Science Center at Houston (UTHealth Houston)
- Study coordinator: Maria del Mar Romero López, MD, MS, PhD
- Email: Maria.del.Mar.RomeroLopez@uth.tmc.edu
- Phone: 713-500-7283
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.