Набор по приглашению NCT06965842

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

Без фазы С лечением Premature Infants Very Low Birth Weight Infants

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Parent-centered developmental training.
Кому может быть актуально: Состояния в реестре: Premature Infants, Very Low Birth Weight Infants. Базовые параметры: до 1 мес. · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: South Korea
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Другое 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.

Первичные конечные точки

Number of total and average sessions performed (N) [Срок оценки: up to corrected age 6 months]
Percentage of total and average sessions performed (%) [Срок оценки: up to corrected age 6 months]
Number of total and average sessions completed (N) [Срок оценки: up to corrected age 6 months]
Percentage of total and average sessions completed (%) [Срок оценки: up to corrected age 6 months]
Parent questionnaire [Срок оценки: at corrected age 6 months]
General Movement Optimality Score [Срок оценки: corrected age 0, 1.5months]
Motor Optimality Score-Revised [Срок оценки: corrected age 4months]
Hammersmith Infant Neurological Examination [Срок оценки: corrected age 4, 6, 9 months]
Gross Motor Function Measure [Срок оценки: corrected age 6, 9 months]
Bayley Scales of Infant and Toddler Development [Срок оценки: corrected age 9 months]

Критерии участия

Критерии включения

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)