Family Nurture Intervention in the NICU: A Multi-Site Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 461
- 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 very preterm (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU).
The study investigator hypothesizes 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 study aims to:
- Replicate efficacy from an earlier trial by conducting the study at multiple sites to allow for greater generalizability.
- SC, approximately 90 infants plus the parents
- FNI, approximately 90 infants plus the parents
- Term Controls, approximately 25 infants plus the parents
详细描述
Increasing number of studies demonstrating the importance of early mother-infant nurturing interaction on long-term outcomes demonstrates the need for a prevention/remedial intervention in the neonatal intensive care unit (NICU). The foremost goal of neonatal intensive care is to ensure survival and medical stability of the infant. Within the NICU, parental involvement in care is necessarily superseded by the healthcare staff's need to assure survival. Thus, a necessary but detrimental separation between mother and infant is created at a critical period when mother-infant connection and synchrony should be developing. The physiological challenges associated with being born too soon, along with disturbances in normal mother-infant interactions, are key factors underlying the risks of premature infants for a broad range of early and midlife disorders.
Not only are preterm infants at increased risk for adverse outcomes (>50%), but up to 40% of mothers of these infants suffer from depression during the postpartum period and many mothers suffer symptoms of trauma and post-traumatic stress. Importantly, fathers of preterm infants are also at increased for postnatal depression. In addition, a recent review of 10 studies found that mothers of preterm infants are at increased risk for subsequent ischemic heart disease, stroke, atherosclerosis, and death due to cardiovascular disease (CVD). Delivery of a preterm infant has long lasting effects on both parents with both mothers and fathers reporting increased parenting stress when their infants reached 7 years of age.
This study will allow examination of the immediate and long-term effects of new approach on the development of preterm infants and cardiovascular risk of their parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Infant is born between 38-42 weeks gestation
- •Infant is singleton or twin
- •Exclusion criteria:
- •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
排除标准
- 未提供
结局指标
主要结局
EEG Power in the frontal polar region
时间窗: Infant Age at 39-41 Weeks gestational age
Measured in microvolts (µV)\^2
次要结局
- STAI Score(Up to 18 months)
- Neurobehavioral Assessment of Infants - Bayley Scales of Infant and Toddler Development, Bayley III(18 Month corrected age Follow-Up)
- EEG Coherence in the left frontal polar to right frontal polar region(Infant Age at 39-41 Weeks gestational age)
- CES-D Score(Up to 18 months)