Family Nurture Intervention (FNI) in Neonatal Intensive Care Unit (NICU)
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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      (NICU), parental involvement in care is necessarily superseded by the healthcare staff.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.
    

Intervention name(s): Family Nurture Intervention
Intervention type(s): Behavioral
Intervention description(s): Family Nurture Intervention is facilitated by specially trained Nurture Specialists. The intervention involves calming interactions between mother and infant in the isolette via odor exchange, firm sustained touch and vocal soothing, through calming interactions during holding and feeding via the Calming Cycle and through family sessions designed to engage the help and support of family members for the mother.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Separation stress; Family Nurture; Maternal Confidence; Maternal Competence; Calming Cycle; Kangaroo Care; Infant Neurodevelopment; Infant Psychological Development; Post-partum depression; Mother-infant Co-regulation