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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07100353
Enrollment
450
Registered
2025-08-03
Start date
2023-10-01
Completion date
2026-09-30
Last updated
2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Infant

Keywords

Developmental Function, Daily Living, Participation, Quality of Life

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.

Interventions

None listed

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 3 Years
Healthy volunteers
No

Inclusion 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. 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.

Design outcomes

Primary

MeasureTime frame
Bayley scales of infant and Toddler Development- fourth edition, Bailey-IVBaseline
Comprehensive Development Inventory for Infant and Toddlers (CDIIT)Baseline
KIT Development and Health QuestionnaireBaseline
General Movements Assessment (GMA)Baseline
PREMature Infant Index (PREMII)Baseline

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026