NCT02710474

Family Nurture Intervention in the NICU

Family Nurture Intervention in the NICU: A Multi-Site Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 461 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 26 Weeks – 34 Weeks
• Healthy volunteers: Not accepted

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 Within the NICU, parental involvement in care is necessarily superseded by the healthcare staff's need to assure survival.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.

Conditions

• Premature Birth
• Obstetric Labor, Premature

Interventions

Type	Name	Description
BEHAVIORAL	Family Nurture Intervention	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.
BEHAVIORAL	Standard Care	Established routine care provided on the NICU floor by specially trained health care professionals.

Timeline

• Start date: 2017-01-24
• Primary completion: 2020-02-07
• Completion: 2022-12-31
• First posted: 2016-03-16
• Last updated: 2023-02-15

Locations

2 sites across 1 country: United States