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

Chang Gung Medical Foundation

Status: Active, not recruiting

Conditions: Premature Infant

Study type: Observational

Funder types: Other

Identifiers

NCT07100353

202201544B0

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: Under 3 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

3. 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.

Trial design

450 participants in 2 patient groups

Full-term Children

Description:

This study will recruit 100 full-term children (ages 0-3) without neurological or developmental disorders for longitudinal follow-up.

Premature Children

Description:

This study will recruit 350 pretmature children (born \<37 weeks, ages 0-3) in stable treatment for longitudinal follow-up.