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

NCT05498753 | Unknown DMC

• 1 other identifier: 202101737B0
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preterm Birth

Keywords

Body function and body structure; Participation; Life activities; Quality of Life

Outcome Measures

Primary Outcomes (5)

• Change from baseline general development for Healthy child and preterm infants at 6 months 1

  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.)

  From 6 months to 4 years

• Change from baseline general development for Healthy child and preterm infants at 6 months 2

  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.)

  From 6 months to 4 years

• Change from baseline general development for Healthy child and preterm infants at 6 months 3

  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.)

  From 6 months to 4 years

• Change from baseline general development for Healthy child and preterm infants at 6 months 4

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

  From 6 months to 4 years

• Change from baseline functions for preterm infants at 6 months

  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.)

  From 6 months to 4 years

Study Arms (2)

Control

Healthy infants

Experimental

Preterm Infants

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Enroll preterm and healthy infants.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

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

• Chia-Ling Chen

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Central Study Contacts

Chia-Ling Chen

CONTACT

+886-3-3281200; clingchen@gmail.com

Study Design

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

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: August 12, 2022
• Study Start: February 21, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: August 12, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)