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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Premature Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

0 year–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Premature Cases

Inclusion criteria

Born before 37 weeks.
Aged 0-3 years.
Caregivers consent and agree to cooperate.
Stable condition with regular outpatient care, medication, and rehabilitation.

Exclusion criteria

Acute illness (e.g., infection).
Parents/caregivers unable to communicate in Chinese.

Full-term Cases

Inclusion criteria

Born at full term.
Aged 0-3 years.
No disease affecting neurophysiological development.
Caregivers consent and agree to cooperate.

Exclusion criteria

Medical conditions affecting neurophysiological development (e.g., traumatic brain injury).
Neurodevelopmental disorders
Sensory perception disorders
Chromosomal abnormalities
Parents/caregivers unable to communicate in Chinese.

Treatment and study plan

Primary outcomes

Bayley scales of infant and Toddler Development- fourth edition, Bailey-IV

Time frame: Baseline
Comprehensive Development Inventory for Infant and Toddlers (CDIIT)

Time frame: Baseline
KIT Development and Health Questionnaire

Time frame: Baseline
General Movements Assessment (GMA)

Time frame: Baseline
PREMature Infant Index (PREMII)

Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Aug 3, 2025
Registry last updated: Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting