A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways
2018年8月22日 更新者：National Taiwan University Hospital
Four hypotheses will be tested in this study:
- The intervention group performs better in child, parent and transactions outcomes than the control group throughout the follow-up period.
- The intervention group shows greater changes in early neurophysiological brain functions and transactions within the family that lead to better neurodevelopmental outcomes than the control group.
- Certain polymorphisms of the dopamine-related genes are associated with the neurodevelopmental outcomes in VLBW preterm infants.
- Very low birth weight preterm infants carrying more genetic plasticity in the dopamine-related genes may benefit more from the interventions than those carrying less genetic plasticity.
調査の概要
詳細な説明
A total of 275 VLBW preterm infants (269 participants and 6 pilots) were recruited at three medical centers in northern and southern Taiwan and were randomly assigned to the FCIP or UCP group.
Outcome assessments included primary (neurobehavioral development) and secondary measures (neurophysiological performance, parents' stress and transactions within the family).
The neurophysiological and transactions data were examined for whether they mediate intervention effects on child development.
In addition, these infants 219 VLBW preterm infants and 118 term infants in our prior intervention studies were collected buccal cells for assessment of the polymorphisms of dopamine-related genes, which are involved in the neurotransmission of cognitive, sensorimotor and behavioral-emotional systems and postulated to be associated with several developmental and psychiatric illnesses.
The polymorphisms of dopamine-related genes were examined for potential moderating influence on the effects of the intervention for child development.
研究の種類
介入
入学 (実際)
275
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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Tainan、台湾、704
- National Cheng Kung University Hospital
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Taipei、台湾、100
- National Taiwan University Hospital
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Taipei、台湾、104
- Mackay Memorial Hospital
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
8ヶ月歳未満 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- birth body weight < 1500 grams
- gestational age < 37 weeks
- parents of Taiwan nationality, married or together at delivery, and northern family residing in greater Taipei and southern family residing in greater Tainan, Kaohsiung, or Chiayi
Exclusion Criteria:
- severe neonatal and perinatal diseases (e.g., seizures, hydrocephalus, meningitis, grade III-IV IVH and grade II NEC)
- congenital or chromosome abnormality
- mother < 18 years, with mental retardation or history of maternal substance abuse at any time (smoking, alcohol, and drug)
Terminated Criteria:
- diagnosis of brain injury (e.g., PVL, stage IV ROP or greater)
- severe cardiopulmonary disease requiring invasive or non-invasive ventilator use at hospital discharge
- hospital discharge beyond 44 weeks' post-menstrual age.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Family-centered intervention program
FCIP: family members were encouraged to present in all intervention sessions included 5 in-hospital intervention, 7 after-discharge interventions (0, 1, 2, 4, 6, 9, and 12 months of corrected age), and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.
|
This program was in-hospital intervention, after-discharge intervention, and neonatal follow-up.
Five sessions of in-hospital intervention emphasized in the parental involvements with modulation of the NICU, a teaching of child developmental skills, feeding support, massage, interactional activities, child developmental skills, parent support and education, and transition home preparation.
The 7-session after-discharge intervention consisted of 4 clinic visits and 3 home visits with specific care in modulation of home environment, teaching of child developmental skills, feeding support, teaching of interactional activities, and parent support and education
他の名前：
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他の：Usual care intervention program
UCP: family members were invited to present at least one session of the 5 in-hospital intervention session.
Parents and infants in the UCP group received 7 after-discharge phone calls (0, 1, 2, 4, 6, 9, and 12 months of corrected age) and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.
|
This program was in-hospital intervention, after-discharge consultation, and neonatal follow-up.
Five sessions of in-hospital intervention emphasized in the parental involvements with modulation of the NICU, a teaching of child developmental skills, feeding support, massage, interactional activities, child developmental skills, parent support and education, and transition home preparation.
The after-discharge service was provided 7-phone calls for the general health consultation.
他の名前：
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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 |
|---|---|---|
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Child: neurodevelopment functions (cognition, language and motor)
時間枠：24 months of corrected age
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Bayley Scales of Infant and Toddler Development - 2nd and 3rd edition
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24 months of corrected age
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change of neurodevelopment functions (motor) from baseline
時間枠：0 months of corrected age
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The Neonatal Neurobehavioral Examination-Chinese Version (NNE-C) 2. World Health Organization Quality of Life- Brief Taiwan version
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0 months of corrected age
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Child: neurodevelopment functions (behavior)
時間枠：24 months of corrected age
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Child behavior checklist version 1.5-5 Y 2. World Health Organization Quality of Life- Brief Taiwan version
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24 months of corrected age
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Change of neurodevelopment functions (cognition, language and motor) from baseline
時間枠：6,12, and 24 months
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Bayley Scales of Infant and Toddler Development - 3rd edition 2. World Health Organization Quality of Life- Brief Taiwan version
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6,12, and 24 months
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Parental functions and change from baseline (pressure)
時間枠：0, 6, 12, 18, and 24 months of corrected age
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Parenting Stress Index 2. World Health Organization Quality of Life- Brief Taiwan version
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0, 6, 12, 18, and 24 months of corrected age
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Parental functions and change from baseline (Quality of Life)
時間枠：0, 6, 12, 18, and 24 months of corrected age
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World Health Organization Quality of Life- Brief Taiwan version
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0, 6, 12, 18, and 24 months of corrected age
|
|
Transactional functions and change from baseline
時間枠：6, 12, and 18 months of corrected age
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Mother-infant interaction in free play at 6, 12, and 18 months of corrected age
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6, 12, and 18 months of corrected age
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Transactional functions and change from baseline
時間枠：6 and 12 months of corrected age
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Wakeful Position Questionnaire at 6 and 12 months of corrected age
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6 and 12 months of corrected age
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Transactions function: affordance
時間枠：18 months of corrected age
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1. Affordances in the Home Environment Motor Development- Chinese version
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18 months of corrected age
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Child: Medical data
時間枠：Birth to 24 months of corrected age
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Chart review
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Birth to 24 months of corrected age
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Child: growth data and change from baseline
時間枠：0, 1, 4, 6, 12, 18, and 24 months of corrected age
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Chart review and measurement
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0, 1, 4, 6, 12, 18, and 24 months of corrected age
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Child: neurophysiological functions and change from baseline
時間枠：1 and 4 months of corrected age
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Electroencephalogram/event-related potential
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1 and 4 months of corrected age
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Child: genotyping and gene expression
時間枠：0 month of corrected age
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Buccal cell collection
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0 month of corrected age
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Parental adherence to Intervention
時間枠：32-36 weeks (5 sessions), 0, 1, 2, 4, 6, 9, and 12 months
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Only assessed in FCIP group
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32-36 weeks (5 sessions), 0, 1, 2, 4, 6, 9, and 12 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Li SJ, Tsao PN, Tu YK, Hsieh WS, Yao NJ, Wu YT, Jeng SF. Cognitive and motor development in preterm children from 6 to 36 months of age: Trajectories, risk factors and predictability. Early Hum Dev. 2022 Sep;172:105634. doi: 10.1016/j.earlhumdev.2022.105634. Epub 2022 Jul 28.
- Yu YT, Huang WC, Hsieh WS, Chang JH, Lin CH, Hsieh S, Lu L, Yao NJ, Fan PC, Lee CL, Tu YK, Jeng SF. Family-Centered Care Enhanced Neonatal Neurophysiological Function in Preterm Infants: Randomized Controlled Trial. Phys Ther. 2019 Dec 16;99(12):1690-1702. doi: 10.1093/ptj/pzz120.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2012年5月22日
一次修了 (実際)
2017年1月10日
研究の完了 (実際)
2017年1月10日
試験登録日
最初に提出
2013年1月29日
QC基準を満たした最初の提出物
2013年3月6日
最初の投稿 (見積もり)
2013年3月8日
学習記録の更新
投稿された最後の更新 (実際)
2018年8月24日
QC基準を満たした最後の更新が送信されました
2018年8月22日
最終確認日
2017年3月1日
詳しくは
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