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

NCT07100353 | Active Not Recruiting DMC

• 1 other identifier: 202201544B0
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Infant

Keywords

Developmental Function; Daily Living; Participation; Quality of Life

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Full-term Children

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

Premature Children

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

Eligibility Criteria

• Age: 0 Years - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This study will recruit 100 full-term children and 350 premature children for a longitudinal follow-up.

You may qualify if:

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

You may not qualify if:

• Acute illness (e.g., infection).
• Parents/caregivers unable to communicate in Chinese.
• \. Full-term Cases
• Born at full term.
• Aged 0-3 years.
• No disease affecting neurophysiological development.
• Caregivers consent and agree to cooperate.
• Medical conditions affecting neurophysiological development (e.g., traumatic brain injury).
• Neurodevelopmental disorders
• Sensory perception disorders
• Chromosomal abnormalities
• Parents/caregivers unable to communicate in Chinese.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Chia-Ling Chen

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

TW (1)