NCT06965842

The Video System to Provide a Developmental Training Guide for Preterm Infants

The Video System to Provide a Developmental Training Guide for In-home, Parent-centered, Early Intervention in Preterm Infants: A Proof of Concept and Feasibility Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 1 Month
• Healthy volunteers: Not accepted

Summary

This study aimed to establish a systematic developmental training guide protocol for parent-centered early intervention and verify the concept and feasibility of a video system for parent-centered in-home developmental therapy under the monitoring of a therapist. The target group is premature infants under 32 weeks of gestation or very low birth weight infants under 1500 g with brain damage. A single-arm intervention group of 10 people was recruited, and considering a dropout rate of 20%, the total number of participants was calculated to be 12. 1:1 monitoring to provide parent-centered early intervention at home after discharge from the neonatal intensive care unit is conducted twice a week for 30 minutes per session using a video platform (Zoom) until the corrected age of 6 months. Parents record the developmental training process using a smartphone and transmit it to the therapist, who analyzes the video data to provide new treatment goals and guidelines. Feasibility assessment included: 1) Exercise diary: Number of total and average sessions performed (N) and percentage (%), number of total and average sessions completed (N) and percentage (%) 2) Parent questionnaire 3) Video analysis: Periodic video education and developmental training video acquisition and analysis 4) Heart rate analysis: Analysis of average heart rate during and after rest and developmental training 5) Safety analysis: Number of times (N) and reasons for exercise interruption during developmental training 6) Developmental assessment: Implementation of developmental assessments such as GMOS, MOS-R, HINE, GMFM, and BSID. For safety assessment, if the following symptoms appear during development training, stop exercising and rest until stable. If oxygen saturation drops by more than 10% compared to resting, causing cyanosis and dyspnea, or if heart rate increases by more than 150 beats/min.

Conditions

• Premature Infants
• Very Low Birth Weight Infants

Interventions

Type	Name	Description
OTHER	Parent-centered developmental training	After discharge from the neonatal intensive care unit, 1:1 monitoring is conducted at home for 30 minutes twice a week using a video conferencing platform (Zoom) until the corrected age of 6 months to provide parent-centered early intervention. Parents film the developmental training process using a smartphone and send the video to the therapist, who analyzes the video data to provide new treatment goals and guidelines.

Timeline

• Start date: 2025-06-24
• Primary completion: 2026-01-30
• Completion: 2028-01-30
• First posted: 2025-05-11
• Last updated: 2025-09-17

Locations

1 site across 1 country: South Korea