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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07238231
Enrollment
6000
Registered
2025-11-20
Start date
2022-03-01
Completion date
2026-02-28
Last updated
2025-11-20

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

Conditions

Full-term Infant, Preterm Infant

Keywords

Birth Conditions, Prognostic Factors

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.

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.

Interventions

OTHERNo Intervention: Observational Cohort

No Intervention: Observational Cohort

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 3 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Bayley-III Cognitive Composite ScoreBaselineStandardized cognitive domain score from the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III). Scale range: higher scores indicate better cognitive development.
Bayley-III Language Composite ScoreBaselineStandardized language domain score from the Bayley-III. Scale range: higher scores indicate better language development.
Bayley-III Motor Composite ScoreBaselineStandardized motor domain score from the Bayley-III. Scale range: higher scores indicate better motor development.
Head CircumferenceBaselineHead circumference measured in centimeters (cm).
Body LengthBaselineBody length measured in centimeters (cm).
Body WeightBaselineBody weight measured in kilograms (kg).
Neurological Examination ScoreBaselineResults from standardized neurological assessment. Scale range: higher scores indicate better neurological function.
Mobility Ability ScoreBaselineFunctional mobility assessed using age-appropriate developmental checklist. Scale range: higher scores indicate greater independence.
Presence of Medical Complications/ComorbiditiesBaselineRecorded as a binary variable (Yes/No). Unit: Proportion (%)
Rehabilitation ParticipationBaselineFrequency of rehabilitation sessions per week based on clinical records. Unit: Sessions per week

Countries

Taiwan

Outcome results

None listed

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