Clinical trial NCT05498753: Development, ADL, Participation, and Quality of Life in Preterm Infants: A Longitudinal Follow Up Study
Official title: Development, ADL, Participation, and Quality of Life in Preterm Infants: A Longitudinal Follow Up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Birth
Keywords: Body function and body structure
Participation
Life activities
Quality of Life
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enroll preterm and healthy infants.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Children who were born before 37 weeks
* Age 0-3 y/o
* Agree to sign inform consent

Exclusion Criteria:

* Active medical condition (e.g. infection)
* Concurrent disease which affect nuerological development, such as cerebral palsy, or other disease not typically associated with preterm

Primary outcomes:
measure: Change from baseline general development for Healthy child and preterm infants at 6 months 1
timeFrame: From 6 months to 4 years
measure: Change from baseline general development for Healthy child and preterm infants at 6 months 2
timeFrame: From 6 months to 4 years
measure: Change from baseline general development for Healthy child and preterm infants at 6 months 3
timeFrame: From 6 months to 4 years
measure: Change from baseline general development for Healthy child and preterm infants at 6 months 4
timeFrame: From 6 months to 4 years
measure: Change from baseline functions for preterm infants at 6 months
timeFrame: From 6 months to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling Chen
role: STUDY_DIRECTOR
References: