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Clinical Trials in Taiwan / NCT07100353
Active, not recruiting Observational

Premature Infants' Developmental Function, Daily Living, Participation, and Quality of Life: A Longitudinal Study

NCT07100353 · tracked via the Priya Life Science Taiwan tracker
Sponsor
Chang Gung Memorial Hospital
Phase
Observational
Started
2023-10-01
Last updated
2025-08-03

Condition(s) studied

Premature Infant

Study summary

This study tracks the long-term development of premature infants to examine how birth profiles, risk factors, and physical functioning influence their activities, participation, and quality of life. It also identifies predictors of functional outcomes, evaluates assessment tool sensitivity, validates the General Movements Assessment (GMA) as a prognostic tool, and compares findings with the Taiwan Infant Development Database. The study hypothesizes that birth conditions and postnatal complications predict differences in development and well-being, that risk factors and physical function relate to participation and quality of life, and that the GMA will show reliable validity across disability categories.

Eligibility

Sex
ALL
Min age
0 Years
Max age
3 Years
Healthy volunteers
No
1\. Premature Cases Inclusion criteria: 1. Born before 37 weeks. 2. Aged 0-3 years. 3. Caregivers consent and agree to cooperate. 4. Stable condition with regular outpatient care, medication, and rehabilitation. Exclusion criteria: 1. Acute illness (e.g., infection). 2. Parents/caregivers unable to communicate in Chinese. 2\. Full-term Cases Inclusion criteria: 1. Born at full term. 2. Aged 0-3 years. 3. No disease affecting neurophysiological development. 4. Caregivers consent and agree to cooperate. Exclusion criteria: 1. Medical conditions affecting neurophysiological development (e.g., traumatic brain injury). 2. Neurodevelopmental disorders 3. Sensory perception disorders 4. Chromosomal abnormalities 5. Parents/caregivers unable to communicate in Chinese.

Primary outcome measure(s)

  • Bayley scales of infant and Toddler Development- fourth edition, Bailey-IV — Baseline
  • Comprehensive Development Inventory for Infant and Toddlers (CDIIT) — Baseline
  • KIT Development and Health Questionnaire — Baseline
  • General Movements Assessment (GMA) — Baseline
  • PREMature Infant Index (PREMII) — Baseline

Trial sites (1)

FacilityCityRegionStatus
Chang Gung Memorial Hospital Taoyuan Taiwan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07100353 on ClinicalTrials.gov ↗ ← All trials in Taiwan