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

NCT ID: NCT07238231

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 6000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2026-02-28

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.

Conditions

Preterm Infant; Full-term Infant

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No Intervention: Observational Cohort

Intervention Type: 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).

No Intervention: Observational Cohort

Intervention Type: 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.

No Intervention: Observational Cohort

Intervention Type: OTHER

No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort

No Intervention: Observational Cohort

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chia-Ling Chen, MD, PhD

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

202200008B0

Identifier Type: -

Identifier Source: org_study_id