Family Nurture Intervention in the NICU at The Valley Hospital
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 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
    

Detailed description: 
      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.
    

Intervention name(s): Family Nurture Intervention (FNI); Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will be guided by the nursing staff through an enhanced program of mother/infant interactions, which include skin-to-skin holding.; Established routine care provided on the NICU floor by specially trained health care professionals.
Other intervention name(s): FNI; SC
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: preterm birth; NICU; neonatal; skin to skin; kangaroo care; separation stress; family nurture; maternal confidence; maternal competence; calming cycle; infant neurodevelopment; infant psychological development; mother-infant co-regulation; postpartum depression