Enhancement of Co-regulation Between Mother and Infant Via Family Nurture Intervention (FNI) in the NICU: Short and Long Term Effects on Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- Length of Stay
研究概览
简要总结
The purpose of this study is to test the efficacy of a family nurture intervention in the neonatal intensive care unit (NICU). Infants receiving enhanced mother-infant and family nurture are compared to infants receiving standard NICU care. The intervention enhances mother/infant interactions that are vital to early development in the infant. The main goal is to get the mother and infant into biological synchrony, emotional attunement and mutual calm through an activity referred to as a "calming cycle". Mother's are encouraged to engage in the calming cycle activities as much as possible. Her increased effectiveness in calming her infant is hypothesized to improve the mother's view of her baby, reduce negative emotions about having delivered a baby prematurely, and help her gain confidence in her care-taking abilities, which in other studies predicted shorter length of stay and fewer re-hospitalizations. Another goal is to assist mothers in repeating the calming cycle activities providing appropriate types of stimulation for their babies that are important for social, emotional, and neurobehavioral development. Since preterm babies are often easily upset, mothers will be taught how to comfort and calm their babies. Assessments in the NICU and in follow-up visits for two years will test the immediate and long-term effects of this new approach to the nurture of prematurely born infants.
详细描述
The stress that results from preterm birth, requisite acute care and prolonged physical separation in the NICU can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of an optimal mother-infant relationship. Within the neonatal intensive care unit (NICU), parental involvement in care is necessarily superseded by the healthcare staff. Thus, a necessary but detrimental separation between mother and infant is created at a critical period when mother-infant bonding 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. This study aims to highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges by implementing a randomized controlled trial of Family Nurture Intervention in the NICU. The most important source of regulatory input is through contact with the mother and her nurturing behavior. Mother-infant interactions are the foundation for the organization of the infant's neurobiological, sensory, perceptual, emotional, physical, and relational systems. The infant's responses to the mother provide critical feedback which shapes her behavior as well. There are many co-regulatory processes embedded in these synchronous and reciprocal interactions which cross neurophysiological and neurobehavioral domains. The intervention is designed to increase biologically important activities and behaviors that enhance maternally-mediated sensory experiences of preterm infants, as well as the infant-mediated sensory experiences in the mother. The investigators hypothesize that repeated engagement of the mother and her infant in the intervention's calming activities will increase the effectiveness of co-regulation and have immediate and long-term beneficial effects for both. The study is assessing the physiological and behavioral outcomes of the infants and mothers receiving Family Nurture Intervention versus Standard Care over the course of the NICU stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 a singleton or twin in the Morgan Stanley Children's Hospital in New York City
- •Infant is born 26 and 34 weeks post-conceptional age (PCA)
排除标准
- •Mothers cannot understand or speak English
- •Mother has history of drug addiction, psychosis or other severe mental illness
- •There is not at least one adult other than the mother in the home
- •Infant birth weight is below the third percentile for gestational age
- •Infant has significant congenital defects
结局指标
主要结局
Length of Stay
时间窗: From Infant's birth to discharge from NICU
Length of stay will be determined based on the infant's number of days as an inpatient at the Children's Hospital of New York (CHONY) NICU.
次要结局
- Mother-Infant Interactions Assessments: Evaluating the qualities of the mother's interaction with her infant during diaper change(Up to 4 months corrected age)
- Assessments of Neonatal Intensive Care Unit Activities: Ascertainment of attendance and the frequency and/or time spent engaged in key aspects of the Family Nurture Intervention using maternal self-report forms.(Participants will be followed for the duration of NICU stay, an expected average of 7 weeks)
- Physiological Assessments: A one hour recording of high density electroencephalogram (EEG) (128 leads), electrocardiogram (ECG), and respiration during sleep.(Up to 42 weeks post-conceptional age)
- Mother-Infant Interaction Assessments- Yale Inventory of Parental Thoughts and Actions (YIPTA)(up to 24 months corrected age)
- Safety and Practicability of Intervention(up to 5 years)
- Neurobehavioral Assessments of Infants: Mothers provide a wide range of information about infant's development through questionnaires(Up to 24 months corrected age)
- Physiological Assessments- Cortisol Levels, breast milk, saliva, infant blood samples, and infant stool collection(Up to 24 months corrected age)
- Psychological Assessments: Mothers in both groups are given a wide-range of psychological questionnaires. These include indices of anxiety, depression, temperament, personality, attachment, stress, and social support.(Up to 24 months of Age)
- Neurobehavioral Assessments of Infants: The use of the NICU Network Neurobehavioral Scale (NNNS) to assess infant's neurodevelopmental status(Up to 40 weeks Gestational Age)
- Neurobehavioral Assessments of Infants- Bayley Scales of Infant and Toddler Development, Bayley III(Up to 24 months corrected age)
- Mother-Infant Interaction Assessments: Mother-infant face-to-face communicative competence, sensitivity of maternal caregiving and mother and infant physiological capacity to cope with a stressor(Up to 24 months corrected age)
研究者
Martha G Welch
Assistant Professor of Clinical Psychiatry
Columbia University