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临床试验/NCT03267043
NCT03267043已完成不适用

Family Nurture Intervention in the NICU at The Valley Hospital

Columbia University3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
3
主要终点
EEG Power in the frontal polar region

研究概览

简要总结

The purpose of this study is to compare neurodevelopment and activity in infants born preterm (25 to 34 1/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU).

The investigators hypothesize that FNI will improve: i) neonatal electroencephalographic activity ii) maternal caregiving and wellbeing (psychological and physiological, and iii) infant behavior and neurodevelopment at 18 months corrected age (CA).

The two-phase effectiveness study aims to:

  • Phase 1 - Examine the existing Standard Care Approximately 35 infants and their mothers
  • Phase 2 - Examine effectiveness by implementing FNI unit-wide so that every baby receives the intervention Approximately 35 infants and their mothers

详细描述

This study aims to build upon the findings of the earlier randomized controlled trial (RCT) conducted at the Columbia University Medical Center (CUMC) comparing effects, both physiological and emotional, of the current standard method of encouraging contact between mothers and their babies in the NICU with the more specific approach of Family Nurture Intervention (FNI). In addition to receiving standard care, NICU families assigned to FNI received added intervention that focused on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay.

The investigators wish to conduct an effectiveness trial to evaluate if the family nurture intervention's findings can be replicated on a unit-wide level. This effectiveness trial will take place over two parts. There will be two groups; standard care (SC) and intervention (FNI). Phase 1 of the effectiveness study will evaluate the standard care (SC) group in the unit as a baseline measurement and point of comparison to determine if unit-wide FNI reproduces its prior findings (Phase 2). The standard care group (Phase 1) will receive the current standard of care in the NICU. In Phase 2, FNI will be implemented unit-wide, but infants born between 26 weeks and 0 days to 33 weeks 6 days gestation will be eligible to be enrolled into the study. In addition to receiving standard care, patients enrolled during phase 2 will receive added interventions from the trained FNI nursing staff. These added interventions will include supporting the parents and facilitating contact between mother and infant during their infant's NICU stay.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
26 Weeks 至 34 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • infant is between 26 and 33 6/7 weeks gestational age upon admission
  • infant is a singleton or twin

排除标准

  • infant's attending physician does not recommend enrollment in the study
  • severe congenital anomalies including chromosomal anomalies
  • ultrasound evidence of large parenchymal hemorrhagic infarction (>2 cm, intraventricular hemorrhage grade 3 or 4)
  • infant cardiac anomalies
  • mother has known history of substance abuse, severe psychiatric illness or psychosis
  • status of enrolled subject changes and subject now falls into exclusion criteria
  • mother and/or infant has a medical condition that precludes intervention components
  • mother and/or infant has a contagion that endangers other participants in the study

结局指标

主要结局

EEG Power in the frontal polar region

时间窗: Up to 41 weeks gestational age

Measured in microvolts (µV)\^2 for infants.

次要结局

  • State-Trait Anxiety Inventory (STAI) Score(Up to 18 months)
  • Neurobehavioral Assessments of Infants - Bayley Scales or Infant and Toddler Development, Bayley III(Up to 18 months)
  • EEG Coherence in the left frontal polar to right frontal polar region(Up to 41 weeks gestational age)
  • CES-D Score(Up to 18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martha G Welch

Associate Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)

Columbia University

研究点 (3)

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