Family Nurture Intervention in the NICU
Condition: Premature Birth; Obstetric Labor, Premature
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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      parental involvement in care is necessarily superseded by the healthcare staff's need to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.
    

Intervention name(s): Family Nurture Intervention; Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Family Nurture Intervention is facilitated by specially trained Nurture Specialists in a randomized controlled trial (RCT) model (Part I) or applied unit-wide (either through dedicated staff or bedside nurses in Part II). Under FNI, specialists or nurses will support the parents and facilitate contact between mother and baby during the infant's NICU stay. 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.; Established routine care provided on the NICU floor by specially trained health care professionals.
Other intervention name(s): FNI; SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: preterm birth; NICU; neonatal; kangaroo care; separation stress; family nurture; maternal confidence; maternal competence; calming cycle; infant neurodevelopment; infant psychological development; mother-infant co-regulation; post-partum depression