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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Infant
• Intervention / Treatment: Other: No intervention will be provided.

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, 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.

• Study Type: Observational
• Enrollment (Estimated): 210

Contacts and Locations

• Study Contact: Name: ChiaLing Chen; Phone Number: 8148 88633281200; Email: chialingchen@gmail.com

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: ChiaLing Chen; Phone Number: 8148 88633281200; Email: chialingchen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

150 preterm children and 60 fullterm children

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preterm; 150 premature infants aged 0-3 years will be collected.	Other: No intervention will be provided.; no intervention will be provided.
Fullterm group; 60 full-term children aged 0-3 years will be collected.	Other: No intervention will be provided.; no intervention will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: ChiaLing Chen, Chang Gung University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: PIFU-CGMH 2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No