Development, ADL, Participation, and Quality of Life in Preterm Infants: A Longitudinal Follow Up Study

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05498753
Collaborator
(none)
1,000
1
25.3
39.6

Study Details

Study Description

Brief Summary

A Longitudinal Study of Function, ADL, and Quality of life of Patients with Developmental Disabilities

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Development, ADL, Participation, and Quality of Life in Preterm Infants: A Longitudinal Follow Up Study
    Anticipated Study Start Date :
    Feb 21, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Mar 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Control

    Healthy infants

    Experimental

    Preterm Infants

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline general development for Healthy child and preterm infants at 6 months 1 [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.)

    2. Change from baseline general development for Healthy child and preterm infants at 6 months 2 [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.)

    3. Change from baseline general development for Healthy child and preterm infants at 6 months 3 [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.)

    4. Change from baseline general development for Healthy child and preterm infants at 6 months 4 [From 6 months to 4 years]

      General Movements Assessment (GMA) is used to examine the motor function. (Higher scores mean a better outcome.)

    5. Change from baseline functions for preterm infants at 6 months [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.)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 3 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chang Gung Memorial Hospital Taoyuan Taiwan 333

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital

    Investigators

    • Study Director: Chia-Ling Chen, Chang Gung Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT05498753
    Other Study ID Numbers:
    • 202101737B0
    First Posted:
    Aug 12, 2022
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chang Gung Memorial Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 12, 2022