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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
275
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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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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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
不超过 8个月 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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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
其他名称：
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其他：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.
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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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Child: neurodevelopment functions (cognition, language and motor)
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of neurodevelopment functions (motor) from baseline
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
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Transactional functions and change from baseline
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2012年5月22日
初级完成 (实际的)
2017年1月10日
研究完成 (实际的)
2017年1月10日
研究注册日期
首次提交
2013年1月29日
首先提交符合 QC 标准的
2013年3月6日
首次发布 (估计)
2013年3月8日
研究记录更新
最后更新发布 (实际的)
2018年8月24日
上次提交的符合 QC 标准的更新
2018年8月22日
最后验证
2017年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.