Clinical trial NCT06965842: The Video System to Provide a Developmental Training Guide for Preterm Infants
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premature Infants
Very Low Birth Weight Infants
Keywords: developmental training
premature infants
very low birth weight infants
early intervention
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 12
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Number of total and average sessions performed (N)
timeFrame: up to corrected age 6 months
measure: Percentage of total and average sessions performed (%)
timeFrame: up to corrected age 6 months
measure: Number of total and average sessions completed (N)
timeFrame: up to corrected age 6 months
measure: Percentage of total and average sessions completed (%)
timeFrame: up to corrected age 6 months
measure: Parent questionnaire
timeFrame: at corrected age 6 months
measure: General Movement Optimality Score
timeFrame: corrected age 0, 1.5months
measure: Motor Optimality Score-Revised
timeFrame: corrected age 4months
measure: Hammersmith Infant Neurological Examination
timeFrame: corrected age 4, 6, 9 months
measure: Gross Motor Function Measure
timeFrame: corrected age 6, 9 months
measure: Bayley Scales of Infant and Toddler Development
timeFrame: corrected age 9 months
measure: Number of exercise interruption (N)
timeFrame: up to corrected age 6 months
measure: Number of adverse event (N)
timeFrame: up to corrected age 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
References: