Меню
Идёт набор NCT07596147

SAFE Early Intervention for At-Risk Infants

Без фазы С лечением High Risk Infant Neurodevelopmental Disorder (Diagnosis) Preterm

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: SAFE Early Intervention Program, NDT TREATMENT.
Кому может быть актуально
Состояния в реестре: High Risk Infant, Neurodevelopmental Disorder (Diagnosis), Preterm. Базовые параметры: 3 мес. — 12 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Investigation of the Effectiveness of the SAFE Early Intervention Approach on Upper Extremity Function, Fine Motor Skills, and Quality of Life in High-Risk Infants

Обзор

This randomized controlled study aims to investigate the effects of the SAFE early intervention approach on upper extremity function, fine motor skills, and developmental outcomes in high-risk infants aged 3-12 months. Thirty high-risk infants admitted to the Developmental Physiotherapy and Pediatric Rehabilitation Unit of Gazi University Faculty of Health Sciences will be randomly assigned to either the SAFE early intervention group or the Neurodevelopmental Treatment (NDT) group. Infants in the intervention group will receive the SAFE early intervention program for 8 weeks under the supervision of an experienced pediatric physiotherapist. The SAFE approach includes age-appropriate activities focusing on environmental enrichment, promotion of voluntary and goal-directed movements, sensory stimulation, fine motor skill development, postural control, transitional movements, and enhancement of infant-parent interaction through daily routines and home-based activities. Infants in the control group will receive conventional Neurodevelopmental Treatment (NDT) for 8 weeks. The NDT program includes age-specific activities targeting postural control, muscle tone regulation, facilitation of motor development, hand function, balance, weight transfer, and fine motor skills. Families will receive education regarding home-based activities and facilitation techniques specific to their infant's developmental needs. Follow-up will include home visits and weekly telephone monitoring to ensure adherence to the intervention program. Assessments will be performed before the intervention and after the 8-week intervention period by a physiotherapist blinded to group allocation.

Подробное описание

This randomized controlled study investigates the effects of two different early intervention approaches in high-risk infants. The SAFE intervention program is compared with conventional Neurodevelopmental Treatment (NDT). Assessments include upper extremity function, fine motor development, and developmental outcomes measured at baseline and follow-up periods. The study aims to determine which intervention provides superior improvement in early motor and developmental skills.

Вмешательства

  • Поведенческое SAFE Early Intervention Program
    Structured early intervention program designed for high-risk infants focusing on upper extremity function, fine motor development, and neurodevelopmental outcomes during 8 weeks, 5 days/week
  • Поведенческое NDT TREATMENT
    Conventional neurodevelopmental treatment approach focusing on postural control, motor development, and functional movement patterns during 8 weeks, 5days/week

Первичные конечные точки

  • Hand Assessment for Infants (HAI) [Срок оценки: Baseline and after 8 weeks of intervention]
  • Peabody Developmental Motor Scales - Second Edition (PDMS-2) [Срок оценки: Baseline and after 8 weeks of intervention]
Вторичные конечные точки (2)
  • Canadian Occupational Performance Measure (COPM) [Срок оценки: Baseline and after 8 weeks of intervention]
  • PedsQL™ Infant Quality of Life Scale (1-12 Months) [Срок оценки: Baseline and after 8 weeks of intervention]

Критерии участия

Критерии включения

  • Infants aged between 3 and 12 months corrected age Presence of neurodevelopmental risk factors including perinatal stroke, perinatal asphyxia, hypoxic-ischemic encephalopathy, germinal matrix hemorrhage, intraventricular hemorrhage, periventricular leukomalacia, or prematurity at or below 37 weeks of gestation Admission to the Developmental Pediatrics and Pediatric Physiotherapy and Rehabilitation Unit of Gazi University Faculty of Health Sciences Parent or legal guardian willing to participate and provide written informed consent

Критерии исключения

  • Presence of any congenital anomaly Diagnosis of a genetic disorder Any orthopedic problem affecting upper extremity function Families unable to communicate in Turki

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Gazi University Faculty of Health Sciences — Ankara

Идентификаторы

NCT: NCT07596147 · 2026 - 86 · THESIS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗