A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways
2018년 8월 22일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
275
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Tainan, 대만, 704
- National Cheng Kung University Hospital
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Taipei, 대만, 100
- National Taiwan University Hospital
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Taipei, 대만, 104
- Mackay Memorial Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
8개월 이하 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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
다른 이름들:
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다른: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Child: neurodevelopment functions (cognition, language and motor)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change of neurodevelopment functions (motor) from baseline
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2012년 5월 22일
기본 완료 (실제)
2017년 1월 10일
연구 완료 (실제)
2017년 1월 10일
연구 등록 날짜
최초 제출
2013년 1월 29일
QC 기준을 충족하는 최초 제출
2013년 3월 6일
처음 게시됨 (추정)
2013년 3월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 8월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 8월 22일
마지막으로 확인됨
2017년 3월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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