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临床试验/NCT05498753
NCT05498753尚未招募不适用

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

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
试验地点
1
主要终点
Change from baseline general development for Healthy child and preterm infants at 6 months 1

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Months 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 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.)

Change from baseline functions for preterm infants at 6 months

时间窗: 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.)

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

时间窗: From 6 months to 4 years

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

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

时间窗: 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.)

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

时间窗: 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.)

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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