Taiwan Preterm Infant Database: Analysis and Comparison of Birth Conditions and Exploration of Prognostic Factors

NCT07238231 | Active Not Recruiting DMC

• 1 other identifier: 202200008B0
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to conduct a long-term follow-up of preterm infants with different birth conditions, aiming to provide data and resources for future care and to identify predictive and influencing factors related to their functional development over time. It is hypothesized that (1) preterm infants with varying birth conditions, such as birth weight and gestational age, will exhibit different developmental outcomes, and that the establishment of a Taiwan-specific preterm infant database is essential due to the lack of comprehensive local data and ethnic variations in gestational patterns; and (2) neonatal factors, including gestational age, birth weight, and postnatal complications (e.g., pneumonia, seizures, hypoxia), serve as potential risk factors influencing later developmental trajectories.

Conditions

Preterm Infant; Full-term Infant

Keywords

Birth Conditions; Prognostic Factors

Outcome Measures

Primary Outcomes (10)

• Bayley-III Cognitive Composite Score

  Standardized cognitive domain score from the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III). Scale range: higher scores indicate better cognitive development.

  Baseline

• Bayley-III Language Composite Score

  Standardized language domain score from the Bayley-III. Scale range: higher scores indicate better language development.

  Baseline

• Bayley-III Motor Composite Score

  Standardized motor domain score from the Bayley-III. Scale range: higher scores indicate better motor development.

  Baseline

• Head Circumference

  Head circumference measured in centimeters (cm).

  Baseline

• Body Length

  Body length measured in centimeters (cm).

  Baseline

• Body Weight

  Body weight measured in kilograms (kg).

  Baseline

• Neurological Examination Score

  Results from standardized neurological assessment. Scale range: higher scores indicate better neurological function.

  Baseline

• Mobility Ability Score

  Functional mobility assessed using age-appropriate developmental checklist. Scale range: higher scores indicate greater independence.

  Baseline

• Presence of Medical Complications/Comorbidities

  Recorded as a binary variable (Yes/No). Unit: Proportion (%)

  Baseline

• Rehabilitation Participation

  Frequency of rehabilitation sessions per week based on clinical records. Unit: Sessions per week

  Baseline

Study Arms (3)

birth weight group

The cases were subdivided into three groups based on birth weight: the extremely low birth weight group (\<1000 g), the very low birth weight group (1000-1500 g), and the low birth weight group (1500-2500 g).

Other: No Intervention: Observational Cohort

gestational age group

The cases were subdivided into four groups based on gestational age: the extremely preterm group (\<28 weeks), the early preterm group (28-32 weeks), the moderate preterm group (32-34 weeks), and the late preterm group (34-37 weeks).

Other: No Intervention: Observational Cohort

combined comparison group

The cases were subdivided into twelve groups based on the cross-classification of birth weight and gestational age.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No Intervention: Observational Cohort

birth weight group; combined comparison group; gestational age group

Eligibility Criteria

• Age: 0 Years - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Control and experimental group

You may qualify if:

• Born \<37 weeks.
• Age 0-3 years.
• Stable condition with regular outpatient follow-up, medication, and rehabilitation.

You may not qualify if:

• Acute illness (e.g., infection).
• Conditions affecting neurodevelopment (e.g., cerebral palsy, severe complications, pneumonia, traumatic brain injury).
• Chromosomal abnormalities.
• Full-term Cases (Control Group)
• Born at full term.
• Age 0-3 years.
• No disease affecting neurodevelopment.
• Caregiver consent and cooperation.
• Medical diagnoses affecting neurodevelopment (e.g., traumatic brain injury).
• Neurodevelopmental disorders.
• Sensory disorders.
• Chromosomal abnormalities.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples Without 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, MD, PhD

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: November 20, 2025
• Study Start: March 1, 2022
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-08

Locations

TW (1)