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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Preterm Infant; Full-term Infant
• Intervention / Treatment: Other: No Intervention: Observational Cohort

Detailed Description

This study uses Taiwan's Preterm Infant Database to analyze gestational age, birth conditions, and long-term developmental outcomes in preterm infants. Participants are classified by gestational age and birth weight into subgroups, with demographic, clinical, and follow-up data (e.g., Bayley-III, neurodevelopmental exams, rehabilitation records) systematically collected. All data are de-identified, coded, and validated, with confidentiality maintained under IRB oversight. Statistical methods include ANOVA, chi-square, Kruskal-Wallis, repeated-measures ANOVA, and multiple regression models to identify predictive and risk factors. Standardized procedures govern data collection, management, and analysis, with strategies to address missing or inconsistent values. This framework ensures rigor, supports predictive modeling, and provides clinically relevant insights to guide early intervention and healthcare strategies.

• Study Type: Observational
• Enrollment (Actual): 6000

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan District, Taiwan, 333
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Control and experimental group

Description

Preterm Cases (Experimental Group)

Inclusion:

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

Exclusion:

• 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)

Inclusion:

• Born at full term.
• Age 0-3 years.
• No disease affecting neurodevelopment.
• Caregiver consent and cooperation.

Exclusion:

• Medical diagnoses affecting neurodevelopment (e.g., traumatic brain injury).
• Neurodevelopmental disorders.
• Sensory disorders.
• Chromosomal abnormalities.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; 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; No Intervention: Observational Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Director: Chia-Ling Chen, MD, PhD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: August 29, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Prognostic Factors; Birth Conditions
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: 202200008B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No