The Video System to Provide a Developmental Training Guide for Preterm Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parent-centered developmental training.
- Who it may be relevant to
- Registry conditions: Premature Infants, Very Low Birth Weight Infants. Basic parameters: up to 1 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Number of total and average sessions performed (N) [Time frame: up to corrected age 6 months]
- Percentage of total and average sessions performed (%) [Time frame: up to corrected age 6 months]
- Number of total and average sessions completed (N) [Time frame: up to corrected age 6 months]
- Percentage of total and average sessions completed (%) [Time frame: up to corrected age 6 months]
- Parent questionnaire [Time frame: at corrected age 6 months]
- General Movement Optimality Score [Time frame: corrected age 0, 1.5months]
- Motor Optimality Score-Revised [Time frame: corrected age 4months]
- Hammersmith Infant Neurological Examination [Time frame: corrected age 4, 6, 9 months]
- Gross Motor Function Measure [Time frame: corrected age 6, 9 months]
- Bayley Scales of Infant and Toddler Development [Time frame: corrected age 9 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT06965842 · 0420222050