Development, ADL, Participation, and Quality of Life in Preterm Infants: Longitudinal Research

NCT06532695 | Recruiting

• 1 other identifier: PIFU-CGMH 2023
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (5)

• Bayley scales of infant and Toddler Development-fourth edition, Bailey-IV

  evaluate the intellegent quatient of the participants

  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

  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

  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

  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

  initial assessemnt, 3 months, 6 months, 12 months, 18 months, and 24 months follow-up

Study Arms (2)

Preterm

150 premature infants aged 0-3 years will be collected.

Other: No intervention will be provided.

Fullterm group

60 full-term children aged 0-3 years will be collected.

Other: No intervention will be provided.

Interventions

No intervention will be provided. OTHER

no intervention will be provided.

Fullterm group; Preterm

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

150 preterm children and 60 fullterm children

You may qualify if:

• infants with less than 37 weeks of gestation。
• aged 0-3 years old。
• caregivers agree and cooperate
• stable health condition -

You may not qualify if:

• acute health conditions such as infection
• caregivers or parents cannot communicate in Madarine Chinese.-

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• ChiaLing Chen

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ChiaLing Chen

CONTACT

88633281200; chialingchen@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start: December 1, 2022
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)