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

NCT06965842 | Enrolling By Invitation

• 1 other identifier: 0420222050
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

developmental training; premature infants; very low birth weight infants; early intervention

Outcome Measures

Primary Outcomes (12)

• Number of total and average sessions performed (N)

  up to corrected age 6 months

• Percentage of total and average sessions performed (%)

  up to corrected age 6 months

• Number of total and average sessions completed (N)

  up to corrected age 6 months

• Percentage of total and average sessions completed (%)

  up to corrected age 6 months

• Parent questionnaire

  at corrected age 6 months

• General Movement Optimality Score

  Minimum score: 5 Maximum score: 42 Assessing the quality of writhing movements in infants (typically from term age to 6-9 weeks post-term). Higher scores reflect more optimal general movements - smooth, variable, and age-appropriate. Lower scores may suggest abnormal or poor-quality movements, which are associated with neurological risk.

  corrected age 0, 1.5months

• Motor Optimality Score-Revised

  Minimum score: 5 Maximum score: 28 Evaluating fidgety movements and other spontaneous motor patterns in infants (typically from 9 to 20 weeks post-term). Higher scores indicate better motor repertoire and neurological function, and are associated with typical development. Lower scores are often seen in infants at risk for motor disorders, such as cerebral palsy.

  corrected age 4months

• Hammersmith Infant Neurological Examination

  Total Score Range: Minimum: 0 Maximum: 78 The total score is the sum of scores across 26 items, each scored from 0 to 3: 0 = severely abnormal 1. = moderately abnormal 2. = mildly abnormal 3. = normal Higher HINE scores (closer to 78) indicate better neurological function. Lower scores may suggest neurological impairment or risk for conditions such as cerebral palsy.

  corrected age 4, 6, 9 months

• Gross Motor Function Measure

  GMFM-88 Items: 88 items across 5 dimensions: Lying and Rolling Sitting Crawling and Kneeling Standing Walking, Running, and Jumping Scoring per item: 0 to 3 Total Score Range: Minimum: 0% Maximum: 100% (Expressed as a percentage of the maximum possible score) Higher scores represent better gross motor function.

  corrected age 6, 9 months

• Bayley Scales of Infant and Toddler Development

  1. Scaled Scores (for subtests like Fine Motor, Expressive Language, etc.): Range: Minimum: 1 Maximum: 19 Mean: 10 Standard Deviation (SD): 3 2. Composite Scores (for broader domains like Cognitive, Motor, etc.): Range: Minimum: 40 Maximum: 160 Mean: 100 Standard Deviation (SD): 15 130 and above Very Superior 120-129 Superior 110-119 High Average 90-109 Average 80-89 Low Average 70-79 Borderline Below 70 Extremely Low / Delayed

  corrected age 9 months

• Number of exercise interruption (N)

  up to corrected age 6 months

• Number of adverse event (N)

  up to corrected age 6 months

Study Arms (1)

intervention

EXPERIMENTAL

Other: Parent-centered developmental training

Interventions

Parent-centered developmental training OTHER

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.

intervention

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature infants less than 32 weeks of gestation or extremely low birth weight infants less than 1500 g
• Premature infants with a corrected age of less than 1 month
• Brain damage through brain imaging (e.g. cranial USG, brain MRI)

You may not qualify if:

• Multiple malformations or genetic abnormalities
• Severe visual or hearing impairment
• Loss of consciousness
• Tracheostomy
• Medically unstable condition

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 11, 2025
• Study Start: June 24, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): January 30, 2028
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)