Preterm BirthNCT05498753
Development, ADL, Participation, and Quality of Life in Preterm Infants: A Longitudinal Follow Up Study
An observational study of Preterm Birth, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
A Longitudinal Study of Function, ADL, and Quality of life of Patients with Developmental Disabilities Read more about this study
- Who is it for?
- Ages 6 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- How many people
- 1,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Feb 2023to 31 Mar 2025
- 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 6 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Enroll preterm and healthy infants.
Who may be able to join
- Children who were born before 37 weeks
- Age 0-3 y/o
- Agree to sign inform consent
Who cannot join
- Active medical condition (e.g. infection)
- Concurrent disease which affect nuerological development, such as cerebral palsy, or other disease not typically associated with preterm
Trial locations and contacts
1 site in 1 country.
About this study
A Longitudinal Study of Function, ADL, and Quality of life of Patients with Developmental Disabilities
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, activity, participation, and quality of life (QOL).
This study included validity and reliability study and a prospective 2 phases, 3-years period longitudinal study of patient with preterm infant. From the first half year, 50 used-to-be preterm infant children and 50 used-to-be full-term infant children will be recruited to examine the reliability and validity of assessment tools and examiner. From the late half of the 1st and following years, 100 used-to-be full-term infant children (0-3 years old) and 200 used-to-be preterm infant children will be recruited for follow up research. All participants will receive a series of FPLA and HRQOL assessments, which are based on ICF-CY framework. Examiners will select assessment tools that appropriate to participant's age. Moreover, during this prospective longitudinal study, each participant will receive FPLA and HRQOL assessments as baseline, and re-evaluation every 6-months after the first data collection point. We believe the results of this study will refine services and supports for children with preterm infant to meet these goals.
- Conditions
- Preterm Birth
- Keywords
- Body function and body structure, Participation, Life activities, 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 |
|---|---|---|
| Control | Healthy infants | |
| Experimental | Preterm Infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline general development for Healthy child and preterm infants at 6 months 1
Bayley scales of infant and Toddler Developmentfourth edition is used to examine the body function, motor function, cognitive, language, and social behavior.
(Scores from 0 to 140, higher scores mean a better outcome.)
Measured: From 6 months to 4 years
Change from baseline general development for Healthy child and preterm infants at 6 months 2
Comprehensive Development Inventory for Infant and Toddlers (CDIIT) is used to examine the body function, motor function, cognitive, language, and social behavior.
(Higher scores mean a better outcome.)
Measured: From 6 months to 4 years
Change from baseline general development for Healthy child and preterm infants at 6 months 3
Hawaii Early Learning Profile (HELP) is used to examine the regulatory/sensory orginization, motor function, cognitive, language, and social behavior, and self-help. (Higher scores mean a better outcome.)
Measured: From 6 months to 4 years
Change from baseline general development for Healthy child and preterm infants at 6 months 4
General Movements Assessment (GMA) is used to examine the motor function. (Higher scores mean a better outcome.)
Measured: From 6 months to 4 years
Change from baseline functions for preterm infants at 6 months
PREMature Infant Index(PREMII) is used to examine the respiratory support, oxygen administration, apnea, bradycardia, desaturation, thermoregulation, feeding, and weight.
(Higher scores mean a better outcome.)
Measured: From 6 months to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start21 Feb 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- 1,000 participants (estimated)
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
- NCT05498753
- Sponsor's protocol ID
- 202101737B0
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Aug 2022. 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: A Longitudinal Follow Up Study
- ClinicalTrials.gov ID
- NCT05498753
- Acronym / sponsor ID
- 202101737B0
- Conditions
- Preterm Birth
- Keywords
- Body function and body structure, Participation, Life activities, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 21 Feb 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 12 Aug 2022 (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.
A Longitudinal Study of Function, ADL, and Quality of life of Patients with Developmental Disabilities
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, activity, participation, and quality of life (QOL).
This study included validity and reliability study and a prospective 2 phases, 3-years period longitudinal study of patient with preterm infant. From the first half year, 50 used-to-be preterm infant children and 50 used-to-be full-term infant children will be recruited to examine the reliability and validity of assessment tools and examiner. From the late half of the 1st and following years, 100 used-to-be full-term infant children (0-3 years old) and 200 used-to-be preterm infant children will be recruited for follow up research. All participants will receive a series of FPLA and HRQOL assessments, which are based on ICF-CY framework. Examiners will select assessment tools that appropriate to participant's age. Moreover, during this prospective longitudinal study, each participant will receive FPLA and HRQOL assessments as baseline, and re-evaluation every 6-months after the first data collection point. We believe the results of this study will refine services and supports for children with preterm infant to meet these goals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Healthy infants |
| Experimental | – | –Preterm Infants |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Enroll preterm and healthy infants.
Key inclusion criteria (3 listed)
- Children who were born before 37 weeks
- Age 0-3 y/o
- Agree to sign inform consent
Key exclusion criteria (2 listed)
- Active medical condition (e.g. infection)
- Concurrent disease which affect nuerological development, such as cerebral palsy, or other disease not typically associated with preterm
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
Change from baseline general development for Healthy child and preterm infants at 6 months 1
Time frame: From 6 months to 4 years
Bayley scales of infant and Toddler Developmentfourth edition is used to examine the body function, motor function, cognitive, language, and social behavior. (Scores from 0 to 140, higher scores mean a better outcome.)
Change from baseline general development for Healthy child and preterm infants at 6 months 2
Time frame: From 6 months to 4 years
Comprehensive Development Inventory for Infant and Toddlers (CDIIT) is used to examine the body function, motor function, cognitive, language, and social behavior. (Higher scores mean a better outcome.)
Change from baseline general development for Healthy child and preterm infants at 6 months 3
Time frame: From 6 months to 4 years
Hawaii Early Learning Profile (HELP) is used to examine the regulatory/sensory orginization, motor function, cognitive, language, and social behavior, and self-help. (Higher scores mean a better outcome.)
Change from baseline general development for Healthy child and preterm infants at 6 months 4
Time frame: From 6 months to 4 years
General Movements Assessment (GMA) is used to examine the motor function. (Higher scores mean a better outcome.)
Change from baseline functions for preterm infants at 6 months
Time frame: From 6 months to 4 years
PREMature Infant Index(PREMII) is used to examine the respiratory support, oxygen administration, apnea, bradycardia, desaturation, thermoregulation, feeding, and weight. (Higher scores mean a better outcome.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No
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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 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 Birth, 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 3 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 12 Aug 2022. 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 Chia-Ling Chen (+886-3-3281200 ext. 8148, clingchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline general development for Healthy child and preterm infants at 6 months 1 (time frame: From 6 months to 4 years). 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 12 Aug 2022.