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

November 18, 2025 updated by: Chang Gung Memorial Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
Bayley-III Language Composite Score
Time Frame: Baseline
Standardized language domain score from the Bayley-III. Scale range: higher scores indicate better language development.
Baseline
Bayley-III Motor Composite Score
Time Frame: Baseline
Standardized motor domain score from the Bayley-III. Scale range: higher scores indicate better motor development.
Baseline
Head Circumference
Time Frame: Baseline
Head circumference measured in centimeters (cm).
Baseline
Body Length
Time Frame: Baseline
Body length measured in centimeters (cm).
Baseline
Body Weight
Time Frame: Baseline
Body weight measured in kilograms (kg).
Baseline
Neurological Examination Score
Time Frame: Baseline
Results from standardized neurological assessment. Scale range: higher scores indicate better neurological function.
Baseline
Mobility Ability Score
Time Frame: Baseline
Functional mobility assessed using age-appropriate developmental checklist. Scale range: higher scores indicate greater independence.
Baseline
Presence of Medical Complications/Comorbidities
Time Frame: Baseline
Recorded as a binary variable (Yes/No). Unit: Proportion (%)
Baseline
Rehabilitation Participation
Time Frame: Baseline
Frequency of rehabilitation sessions per week based on clinical records. Unit: Sessions per week
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Chia-Ling Chen, MD, PhD, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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