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

Active, not recruiting

• Conditions: Premature Infant

• Registration Number: NCT07100353
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-28
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan