Preterm InfantNCT06532695
Development, ADL, Participation, and Quality of Life in Preterm Infants: Longitudinal Research
An observational study of Preterm Infant, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The three fundamental goals of early rehabilitation for preterm infant after leaving NICU are: optimizing function within each child's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting children's participation and qualities in their lives. Read more about this study
- Who is it for?
- Ages Up to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Infant
- How many people
- 210 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2022to 30 Nov 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 150 preterm children and 60 fullterm children
Who may be able to join
- infants with less than 37 weeks of gestation。
- aged 0-3 years old。
- caregivers agree and cooperate
- stable health condition -
Who cannot join
- acute health conditions such as infection
- caregivers or parents cannot communicate in Madarine Chinese.-
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan
ChiaLing Chen, 88633281200 ext. 8148, chialingchen@gmail.com
About this study
The three fundamental goals of early rehabilitation for preterm infant after leaving NICU are: optimizing function within each child's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting children's participation and qualities in their lives. Understanding knowledges of these developmental patterns of Function and Participation in Life Activities (FPLA) and HRQOL may be helpful for anticipating and managing the problems. This study hypothesizes that the course of developmental patterns in FPLA and HRQOL of preterm infant evolve with their age. The functional recovery levels include developmental function, health, activity, participation, and quality of life (QOL).
Since the previous plan only passed one year and encountered the COVID-19, the number of cases was not as expected. Therefore, this study will use the previous plan to test the functions of reliability, validity, and the evaluation of daily life participation to investigate the long-term performance of premature infants. Vertical development model under tracking. In addition, it is also expected to identify predictors related to the prognosis of preterm infants and compared with the healthy children of the Taiwan Early Childhood Development Survey Database (KIT) to find out the key differences in the developmental function and health of premature infants and healthy children. This study is a three-year longitudinal study of premature infants. It was carried out for three years. 60 full-term children aged 0-3 years and 150 premature infants aged 0-3 years were collected. A total of 210 children underwent a three-year period study. During the follow-up period, in addition to the initial evaluation, each subject will be followed up at 3 months, 6 months, 12 months, 18 months, and 24 months, toddlers( >24months) will be followed up once a year according to the age of KIT's admission, and we will provide caregiver assessment report. We believe the results of this study will improve and support services provided to preterm infants.
Read the detailed description
Preterm Infant is defined as a group of patients whose gestational age is lower than 37 weeks due to either iatrogenic reasons or maternal reasons. Preterm infant could be classified into 4 group according to gestational age: very early preterm infant, early preterm infant, midterm preterm infant, and late preterm infant. Moreover, they could be categorized into 3 groups of birth weight: extremely low birth weight, very low birth weight, and low birth weight. These varies of preterm infant are indicated to have further developmental and body-functional difficulties and lags. Under the basis of International Classification of Functioning, Disability and Health-Children and Youth Version (ICF-CY) framework, problems related to Preterm infant would further limit their activities of daily living (ADL), participation, and health related quality of life (HRQOL).
The three fundamental goals of early rehabilitation for preterm infant after leaving NICU are: optimizing function within each child's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting children's participation and qualities in their lives. Understanding knowledges of these developmental patterns of Function and Participation in Life Activities (FPLA) and HRQOL may be helpful for anticipating and managing the problems. This study hypothesizes that the course of developmental patterns in FPLA and HRQOL of preterm infant evolve with their age. The functional recovery levels include developmental function, health, activity, participation, and quality of life (QOL).
Since the previous plan only passed one year and encountered the COVID-19, the number of cases was not as expected. Therefore, this study will use the previous plan to test the functions of reliability, validity, and the evaluation of daily life participation to investigate the long-term performance of premature infants. Vertical development model under tracking. In addition, it is also expected to identify predictors related to the prognosis of preterm infants and compared with the healthy children of the Taiwan Early Childhood Development Survey Database (KIT) to find out the key differences in the developmental function and health of premature infants and healthy children. This study is a three-year longitudinal study of premature infants. It was carried out for three years. 60 full-term children aged 0-3 years and 150 premature infants aged 0-3 years were collected. A total of 210 children underwent a three-year period study. During the follow-up period, in addition to the initial evaluation, each subject will be followed up at 3 months, 6 months, 12 months, 18 months, and 24 months, toddlers( >24months) will be followed up once a year according to the age of KIT's admission, and we will provide caregiver assessment report. We believe the results of this study will improve and support services provided to preterm infants.
- Conditions
- Preterm Infant
- Being tested
- No intervention will be provided.
- 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 will be provided.Other
no intervention will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Preterm | 150 premature infants aged 0-3 years will be collected. Receives: Other: No intervention will be provided. | |
| Fullterm group | 60 full-term children aged 0-3 years will be collected. Receives: Other: No intervention will be provided. |
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
evaluate the intellegent quatient of the participants
Measured: initial assessemnt, 3 months, 6 months, 12 months, 18 months, and 24 months follow-up
Comprehensive Development Inventory for Infant and Toddlers, CDIIT
evaluate the development of the participants
Measured: initial assessemnt, 3 months, 6 months, 12 months, 18 months, and 24 months follow-up
KIT development and health questionnaire
assess the development and health conditions of the participants
Measured: initial assessemnt, 3 months, 6 months, 12 months, 18 months, and 24 months follow-up
General Movements Assessment, GMA
assess the general movement of the participants
Measured: initial assessemnt, 3 months, 6 months, 12 months, 18 months, and 24 months follow-up
PREMature Infant Index, PREMII
assess the level of premature status
Measured: initial assessemnt, 3 months, 6 months, 12 months, 18 months, and 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Dec 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ChiaLing Chen, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532695
- Sponsor's protocol ID
- PIFU-CGMH 2023
- Status last verified
- May 2024
- First submitted
- 30 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, ADL, Participation, and Quality of Life in Preterm Infants: Longitudinal Research
- ClinicalTrials.gov ID
- NCT06532695
- Acronym / sponsor ID
- PIFU-CGMH 2023
- Conditions
- Preterm Infant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 1 Aug 2024 (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 three fundamental goals of early rehabilitation for preterm infant after leaving NICU are: optimizing function within each child's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting children's participation and qualities in their lives. Understanding knowledges of these developmental patterns of Function and Participation in Life Activities (FPLA) and HRQOL may be helpful for anticipating and managing the problems. This study hypothesizes that the course of developmental patterns in FPLA and HRQOL of preterm infant evolve with their age. The functional recovery levels include developmental function, health, activity, participation, and quality of life (QOL).
Since the previous plan only passed one year and encountered the COVID-19, the number of cases was not as expected. Therefore, this study will use the previous plan to test the functions of reliability, validity, and the evaluation of daily life participation to investigate the long-term performance of premature infants. Vertical development model under tracking. In addition, it is also expected to identify predictors related to the prognosis of preterm infants and compared with the healthy children of the Taiwan Early Childhood Development Survey Database (KIT) to find out the key differences in the developmental function and health of premature infants and healthy children. This study is a three-year longitudinal study of premature infants. It was carried out for three years. 60 full-term children aged 0-3 years and 150 premature infants aged 0-3 years were collected. A total of 210 children underwent a three-year period study. During the follow-up period, in addition to the initial evaluation, each subject will be followed up at 3 months, 6 months, 12 months, 18 months, and 24 months, toddlers( >24months) will be followed up once a year according to the age of KIT's admission, and we will provide caregiver assessment report. We believe the results of this study will improve and support services provided to preterm infants.
Detailed description
Preterm Infant is defined as a group of patients whose gestational age is lower than 37 weeks due to either iatrogenic reasons or maternal reasons. Preterm infant could be classified into 4 group according to gestational age: very early preterm infant, early preterm infant, midterm preterm infant, and late preterm infant. Moreover, they could be categorized into 3 groups of birth weight: extremely low birth weight, very low birth weight, and low birth weight. These varies of preterm infant are indicated to have further developmental and body-functional difficulties and lags. Under the basis of International Classification of Functioning, Disability and Health-Children and Youth Version (ICF-CY) framework, problems related to Preterm infant would further limit their activities of daily living (ADL), participation, and health related quality of life (HRQOL).
The three fundamental goals of early rehabilitation for preterm infant after leaving NICU are: optimizing function within each child's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting children's participation and qualities in their lives. Understanding knowledges of these developmental patterns of Function and Participation in Life Activities (FPLA) and HRQOL may be helpful for anticipating and managing the problems. This study hypothesizes that the course of developmental patterns in FPLA and HRQOL of preterm infant evolve with their age. The functional recovery levels include developmental function, health, activity, participation, and quality of life (QOL).
Since the previous plan only passed one year and encountered the COVID-19, the number of cases was not as expected. Therefore, this study will use the previous plan to test the functions of reliability, validity, and the evaluation of daily life participation to investigate the long-term performance of premature infants. Vertical development model under tracking. In addition, it is also expected to identify predictors related to the prognosis of preterm infants and compared with the healthy children of the Taiwan Early Childhood Development Survey Database (KIT) to find out the key differences in the developmental function and health of premature infants and healthy children. This study is a three-year longitudinal study of premature infants. It was carried out for three years. 60 full-term children aged 0-3 years and 150 premature infants aged 0-3 years were collected. A total of 210 children underwent a three-year period study. During the follow-up period, in addition to the initial evaluation, each subject will be followed up at 3 months, 6 months, 12 months, 18 months, and 24 months, toddlers( >24months) will be followed up once a year according to the age of KIT's admission, and we will provide caregiver assessment report. We believe the results of this study will improve and support services provided to preterm infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm | – | Other: No intervention will be provided.150 premature infants aged 0-3 years will be collected. |
| Fullterm group | – | Other: No intervention will be provided.60 full-term children aged 0-3 years will be collected. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 150 preterm children and 60 fullterm children
Key inclusion criteria (4 listed)
- infants with less than 37 weeks of gestation。
- aged 0-3 years old。
- caregivers agree and cooperate
- stable health condition -
Key exclusion criteria (2 listed)
- acute health conditions such as infection
- caregivers or parents cannot communicate in Madarine Chinese.-
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 will be provided.no intervention will be provided. | Other | Fullterm group, Preterm |
Primary outcome
Bayley scales of infant and Toddler Development-fourth edition, Bailey-IV
Time frame: initial assessemnt, 3 months, 6 months, 12 months, 18 months, and 24 months follow-up
evaluate the intellegent quatient of the participants
Comprehensive Development Inventory for Infant and Toddlers, CDIIT
Time frame: initial assessemnt, 3 months, 6 months, 12 months, 18 months, and 24 months follow-up
evaluate the development of the participants
KIT development and health questionnaire
Time frame: initial assessemnt, 3 months, 6 months, 12 months, 18 months, and 24 months follow-up
assess the development and health conditions of the participants
General Movements Assessment, GMA
Time frame: initial assessemnt, 3 months, 6 months, 12 months, 18 months, and 24 months follow-up
assess the general movement of the participants
PREMature Infant Index, PREMII
Time frame: initial assessemnt, 3 months, 6 months, 12 months, 18 months, and 24 months follow-up
assess the level of premature status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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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.
ChiaLing Chen principal investigator
Chang Gung University
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, 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ChiaLing Chen (88633281200 ext. 8148, chialingchen@gmail.com), or a site near the patient. 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: initial assessemnt, 3 months, 6 months, 12 months, 18 months, and 24 months follow-up). 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 1 Aug 2024.