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

NCT ID: NCT07100353

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-09-30

Brief Summary

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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

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Conditions

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Premature Infant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Full-term Children

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

No interventions assigned to this group

Premature Children

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

No interventions assigned to this group

Eligibility Criteria

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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.


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

2\. Full-term Cases


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.
Minimum Eligible Age

0 Years

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chia-Ling Chen

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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202201544B0

Identifier Type: -

Identifier Source: org_study_id

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