Efficacy of a Video-based, Parent-centered Home Developmental Intervention for Infants at High Risk for Developmental Delay: a Multicenter Randomized Controlled Trial

StatusNot Yet Recruiting
PhaseNot applicable
Started

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Record History

  1. Study First Submitted
The purpose of this study is to determine whether the Motor Composite Score on the Bayley-III (administered at 6 months of corrected age) shows significant improvement in an intervention group-receiving usual care combined with a video-based home developmental intervention-compared to a control group receiving only usual care, among infants at high risk for developmental delay. The study subjects are infants discharged from the Neonatal Intensive Care Unit (NICU) who were born prematurely at a gestational age of less than 32 weeks or who sustained brain injury. The control group receives usual care only, while the intervention group receives usual care plus a parent-centered developmental training intervention. Parent education for this intervention involves 1:1 monitoring via video conferencing platforms to facilitate parent-centered early intervention at home; sessions last 30 minutes and are conducted once weekly from 0 to 3 months of corrected age and twice weekly from 4 to 6 months of corrected age.
Trial Details
NCT Number NCT07882199
Lead Sponsor Seoul National University Hospital
Collaborators: UNIST (Ulsan National Institute of Science and Technology), Samsung Medical Center, Kangbuk Samsung Hospital, Asan Medical Center, Pusan National University Yangsan Hospital, Chungnam National University Hospital, Chung-Ang University Hospital, Seoul National University Bundang Hospital
Conditions
(from sponsor)
Preterm
Related terms Premature Birth
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov