Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study

Completed · Not applicable

Conditions studied: Understanding of Consent in Clinical Research, Implementation of Video-Consent in Clinical Research

In brief

This pilot randomized controlled trial evaluates the impact of video-enhanced consent compared to the usual approach. The investigators aim to assess if video-enhanced consent empowers decision-making and improves understanding in parents considering participation in the ViDES study, which investigates the effectiveness of Vitamin D supplementation in extremely preterm infants (the ViDES study is separately registered as NCT05459298).

Key facts

Study ID

NCT06446492

Run by

The University of Texas Health Science Center, Houston

People needed

83

Starts

2024-07-01

Expected to finish

2025-06-15

Last updated by the study team

2025-06-26

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• Parents/legal guardians deaf or blind
• Parents/legal guardians unable to consent for the VIDES study

Where it is running

• McGovern Medical School at UTHealth Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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