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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of total and average sessions performed (N)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Multiple malformations or genetic abnormalities
- •Severe visual or hearing impairment
- •Loss of consciousness
- •Tracheostomy
- •Medically unstable condition
结局指标
主要结局
Number of total and average sessions performed (N)
时间窗: up to corrected age 6 months
Percentage of total and average sessions performed (%)
时间窗: up to corrected age 6 months
Number of total and average sessions completed (N)
时间窗: up to corrected age 6 months
Percentage of total and average sessions completed (%)
时间窗: up to corrected age 6 months
Parent questionnaire
时间窗: at corrected age 6 months
Number of exercise interruption (N)
时间窗: up to corrected age 6 months
Number of adverse event (N)
时间窗: up to corrected age 6 months
General Movement Optimality Score
时间窗: corrected age 0, 1.5months
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.
Motor Optimality Score-Revised
时间窗: corrected age 4months
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.
Hammersmith Infant Neurological Examination
时间窗: corrected age 4, 6, 9 months
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.
Gross Motor Function Measure
时间窗: corrected age 6, 9 months
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.
Bayley Scales of Infant and Toddler Development
时间窗: corrected age 9 months
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
次要结局
未报告次要终点
研究者
Woo Hyung Lee
Clinical Associate Professor
Seoul National University Hospital