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NCT Number: NCT07238231

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Preterm Infant Female Urogenital Diseases and Pregnancy Complications Full-term Infant Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

0 year–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No Intervention: Observational Cohort

Other

No Intervention: Observational Cohort

Primary outcomes

  1. Bayley-III Cognitive Composite Score

    Time frame: Baseline

    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.

  2. Bayley-III Language Composite Score

    Time frame: Baseline

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

  3. Bayley-III Motor Composite Score

    Time frame: Baseline

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

  4. Head Circumference

    Time frame: Baseline

    Head circumference measured in centimeters (cm).

  5. Body Length

    Time frame: Baseline

    Body length measured in centimeters (cm).

  6. Body Weight

    Time frame: Baseline

    Body weight measured in kilograms (kg).

  7. Neurological Examination Score

    Time frame: Baseline

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

  8. Mobility Ability Score

    Time frame: Baseline

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

  9. Presence of Medical Complications/Comorbidities

    Time frame: Baseline

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

  10. Rehabilitation Participation

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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