Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT06446492
Status:
COMPLETED
Last Update Posted:
2025-06-26
First Post:
2024-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study
Sponsor:
The University of Texas Health Science Center, Houston
Organization:
Study Overview
Official Title:
Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: