Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532695
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Development ADL Participation and Quality of Life in Preterm Infants Longitudinal Research
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development ADL Participation and Quality of Life in Preterm Infants Longitudinal Research
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The three fundamental goals of early rehabilitation for preterm infant after leaving NICU are optimizing function within each childs prognostic potential preventing the development of secondary conditions that impact life-long health and promoting childrens 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 KITs admission and we will provide caregiver assessment report We believe the results of this study will improve and support services provided to preterm infants
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 KITs 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 childs prognostic potential preventing the development of secondary conditions that impact life-long health and promoting childrens 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 KITs admission and we will provide caregiver assessment report We believe the results of this study will improve and support services provided to preterm infants
The three fundamental goals of early rehabilitation for preterm infant after leaving NICU are optimizing function within each childs prognostic potential preventing the development of secondary conditions that impact life-long health and promoting childrens 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 KITs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None