Premature InfantNCT07100353
Premature Infants' Developmental Function, Daily Living, Participation, and Quality of Life: A Longitudinal Study
An observational study of Premature Infant, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study tracks the long-term development of premature infants to examine how birth profiles, risk factors, and physical functioning influence their activities, participation, and quality of life. Read more about this study
- Who is it for?
- Ages 0 to 3 years
- Conditions the study is for
- Premature Infant
- How many people
- 450 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2023to 30 Sep 2026
- How long will I take part?
- 3 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
- No healthy volunteers
- Child
Study population: This study will recruit 100 full-term children and 350 premature children for a longitudinal follow-up.
Who may be able to join
- Born before 37 weeks.
- Aged 0-3 years.
- Caregivers consent and agree to cooperate.
- Stable condition with regular outpatient care, medication, and rehabilitation.
- Born at full term.
- Aged 0-3 years.
- No disease affecting neurophysiological development.
- Caregivers consent and agree to cooperate.
Who cannot join
- Acute illness (e.g., infection).
- Parents/caregivers unable to communicate in Chinese.
- 2. Full-term Cases
- Medical conditions affecting neurophysiological development (e.g., traumatic brain injury).
- Neurodevelopmental disorders
- Sensory perception disorders
- Chromosomal abnormalities
- Parents/caregivers unable to communicate in Chinese.
Trial locations and contacts
1 site in 1 country.
About this study
This study tracks the long-term development of premature infants to examine how birth profiles, risk factors, and physical functioning influence their activities, participation, and quality of life. It also identifies predictors of functional outcomes, evaluates assessment tool sensitivity, validates the General Movements Assessment (GMA) as a prognostic tool, and compares findings with the Taiwan Infant Development Database. The study hypothesizes that birth conditions and postnatal complications predict differences in development and well-being, that risk factors and physical function relate to participation and quality of life, and that the GMA will show reliable validity across disability categories.
- Conditions
- Premature Infant
- Keywords
- Developmental Function, Daily Living, Participation, Quality of Life
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Full-term Children | This study will recruit 100 full-term children (ages 0-3) without neurological or developmental disorders for longitudinal follow-up. | |
| Premature Children | This study will recruit 350 pretmature children (born <37 weeks, ages 0-3) in stable treatment for longitudinal follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley scales of infant and Toddler Development- fourth edition, Bailey-IV
Measured: Baseline
Comprehensive Development Inventory for Infant and Toddlers (CDIIT)
Measured: Baseline
KIT Development and Health Questionnaire
Measured: Baseline
General Movements Assessment (GMA)
Measured: Baseline
PREMature Infant Index (PREMII)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Oct 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100353
- Sponsor's protocol ID
- 202201544B0
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 3 Aug 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 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premature Infants' Developmental Function, Daily Living, Participation, and Quality of Life: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT07100353
- Acronym / sponsor ID
- 202201544B0
- Conditions
- Premature Infant
- Keywords
- Developmental Function, Daily Living, Participation, Quality of Life
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 3 Aug 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.
This study tracks the long-term development of premature infants to examine how birth profiles, risk factors, and physical functioning influence their activities, participation, and quality of life. It also identifies predictors of functional outcomes, evaluates assessment tool sensitivity, validates the General Movements Assessment (GMA) as a prognostic tool, and compares findings with the Taiwan Infant Development Database. The study hypothesizes that birth conditions and postnatal complications predict differences in development and well-being, that risk factors and physical function relate to participation and quality of life, and that the GMA will show reliable validity across disability categories.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full-term Children | – | –This study will recruit 100 full-term children (ages 0-3) without neurological or developmental disorders for longitudinal follow-up. |
| Premature Children | – | –This study will recruit 350 pretmature children (born <37 weeks, ages 0-3) in stable treatment for longitudinal follow-up. |
Who may qualify
- Ages
- 0 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will recruit 100 full-term children and 350 premature children for a longitudinal follow-up.
Key inclusion criteria (8 listed)
- Born before 37 weeks.
- Aged 0-3 years.
- Caregivers consent and agree to cooperate.
- Stable condition with regular outpatient care, medication, and rehabilitation.
- Born at full term.
Key exclusion criteria (8 listed)
- Acute illness (e.g., infection).
- Parents/caregivers unable to communicate in Chinese.
- 2. Full-term Cases
- Medical conditions affecting neurophysiological development (e.g., traumatic brain injury).
- Neurodevelopmental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bayley scales of infant and Toddler Development- fourth edition, Bailey-IV
Time frame: Baseline
Comprehensive Development Inventory for Infant and Toddlers (CDIIT)
Time frame: Baseline
KIT Development and Health Questionnaire
Time frame: Baseline
General Movements Assessment (GMA)
Time frame: Baseline
PREMature Infant Index (PREMII)
Time frame: Baseline
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 3 Aug 2025.
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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 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 Premature 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 8 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 3 Aug 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 scales of infant and Toddler Development- fourth edition, Bailey-IV (time frame: Baseline). The study lists 5 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 3 Aug 2025.