Preterm InfantNCT07238231
Taiwan Preterm Infant Database: Analysis and Comparison of Birth Conditions and Exploration of Prognostic Factors
An observational study of Preterm Infant and Full-term Infant, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Infant, Full-term Infant
- How many people
- 6,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2022to 28 Feb 2026
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Control and experimental group
Who may be able to join
- Born <37 weeks.
- Age 0-3 years.
- Stable condition with regular outpatient follow-up, medication, and rehabilitation.
- Born at full term.
- Age 0-3 years.
- No disease affecting neurodevelopment.
- Caregiver consent and cooperation.
Who cannot join
- 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)
- Medical diagnoses affecting neurodevelopment (e.g., traumatic brain injury).
- Neurodevelopmental disorders.
- Sensory disorders.
- Chromosomal abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Birth Conditions, Prognostic Factors
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention: Observational Cohort
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Bayley-III Language Composite Score
Standardized language domain score from the Bayley-III. Scale range: higher scores indicate better language development.
Measured: Baseline
Bayley-III Motor Composite Score
Standardized motor domain score from the Bayley-III. Scale range: higher scores indicate better motor development.
Measured: Baseline
Head Circumference
Head circumference measured in centimeters (cm).
Measured: Baseline
Body Length
Body length measured in centimeters (cm).
Measured: Baseline
Body Weight
Body weight measured in kilograms (kg).
Measured: Baseline
Neurological Examination Score
Results from standardized neurological assessment. Scale range: higher scores indicate better neurological function.
Measured: Baseline
Mobility Ability Score
Functional mobility assessed using age-appropriate developmental checklist. Scale range: higher scores indicate greater independence.
Measured: Baseline
Presence of Medical Complications/Comorbidities
Recorded as a binary variable (Yes/No). Unit: Proportion (%)
Measured: Baseline
Rehabilitation Participation
Frequency of rehabilitation sessions per week based on clinical records. Unit: Sessions per week
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Mar 2022
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, MD, PhD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238231
- Sponsor's protocol ID
- 202200008B0
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taiwan Preterm Infant Database: Analysis and Comparison of Birth Conditions and Exploration of Prognostic Factors
- ClinicalTrials.gov ID
- NCT07238231
- Acronym / sponsor ID
- 202200008B0
- Conditions
- Preterm Infant, Full-term Infant
- Keywords
- Birth Conditions, Prognostic Factors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| birth weight group | – | Other: No Intervention: Observational CohortThe 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). |
| gestational age group | – | Other: No Intervention: Observational CohortThe 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). |
| combined comparison group | – | Other: No Intervention: Observational CohortThe cases were subdivided into twelve groups based on the cross-classification of birth weight and gestational age. |
Who may qualify
- Ages
- 0 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Control and experimental group
Key inclusion criteria (7 listed)
- Born <37 weeks.
- Age 0-3 years.
- Stable condition with regular outpatient follow-up, medication, and rehabilitation.
- Born at full term.
- Age 0-3 years.
Key exclusion criteria (8 listed)
- 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)
- Medical diagnoses affecting neurodevelopment (e.g., traumatic brain injury).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo Intervention: Observational Cohort | Other | birth weight group, combined comparison group, gestational age group |
Primary outcome
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.
Bayley-III Language Composite Score
Time frame: Baseline
Standardized language domain score from the Bayley-III. Scale range: higher scores indicate better language development.
Bayley-III Motor Composite Score
Time frame: Baseline
Standardized motor domain score from the Bayley-III. Scale range: higher scores indicate better motor development.
Head Circumference
Time frame: Baseline
Head circumference measured in centimeters (cm).
Body Length
Time frame: Baseline
Body length measured in centimeters (cm).
Body Weight
Time frame: Baseline
Body weight measured in kilograms (kg).
Neurological Examination Score
Time frame: Baseline
Results from standardized neurological assessment. Scale range: higher scores indicate better neurological function.
Mobility Ability Score
Time frame: Baseline
Functional mobility assessed using age-appropriate developmental checklist. Scale range: higher scores indicate greater independence.
Presence of Medical Complications/Comorbidities
Time frame: Baseline
Recorded as a binary variable (Yes/No). Unit: Proportion (%)
Rehabilitation Participation
Time frame: Baseline
Frequency of rehabilitation sessions per week based on clinical records. Unit: Sessions per week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Ling Chen, MD, PhD study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infant and Full-term Infant, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley-III Cognitive Composite Score (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.