Development, ADL, Participation, and Quality of Life in Preterm Infants: A Longitudinal Follow Up Study
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Chia-Ling Chen
- 電話番号:8148 +886-3-3281200
- メール:clingchen@gmail.com
研究場所
-
-
-
Taoyuan、台湾、333
- Chang Gung Memorial Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
コントロール
健康な乳児
|
|
Experimental
Preterm Infants
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline general development for Healthy child and preterm infants at 6 months 1
時間枠: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.) |
From 6 months to 4 years
|
|
Change from baseline general development for Healthy child and preterm infants at 6 months 2
時間枠: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.) |
From 6 months to 4 years
|
|
Change from baseline general development for Healthy child and preterm infants at 6 months 3
時間枠: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.)
|
From 6 months to 4 years
|
|
Change from baseline general development for Healthy child and preterm infants at 6 months 4
時間枠:From 6 months to 4 years
|
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
時間枠: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.) |
From 6 months to 4 years
|
協力者と研究者
捜査官
- スタディディレクター:Chia-Ling Chen、Chang Gung Memorial Hospital
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。