Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety.

Fni Trial Group ,Martha G Welch,Judy Austin,Howard F Andrews,Sara B Glickstein,Michael M Myers,Myron A Hofer,Raymond I Stark,Robert J Ludwig

doi:10.1186/1471-2431-13-148

Fni Trial Group , Martha G Welch + Show 7 more

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https://doi.org/10.1186/1471-2431-13-148

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Journal: BMC Pediatrics	Publication Date: Sep 24, 2013
Citations: 69	License type: cc-by

Affiliation: Columbia University

Abstract

BackgroundWhile survival rates for preterm infants have increased, the risk for adverse long-term neurodevelopmental and behavioral outcomes remains very high. In response to the need for novel, evidence-based interventions that prevent such outcomes, we have assessed Family Nurture Intervention (FNI), a novel dual mother-infant intervention implemented while the infant is in the Neonatal Intensive Care Unit (NICU). Here, we report the first trial results, including the primary outcome measure, length of stay in the NICU and, the feasibility and safety of its implementation in a high acuity level IV NICU.MethodsThe FNI trial is a single center, parallel-group, randomized controlled trial at Morgan Stanley Children’s Hospital for mothers and their singleton or twin infants of 26–34 weeks gestation. Families were randomized to standard care (SC) or (FNI). FNI was implemented by nurture specialists trained to facilitate affective communication between mother and infant during specified calming interactions. These interactions included scent cloth exchange, sustained touch, vocal soothing and eye contact, wrapped or skin-to-skin holding, plus family-based support interactions.ResultsA total of 826 infants born between 26 and 34 weeks during the 3.5 year study period were admitted to the NICU. After infant and mother screening plus exclusion due to circumstances that prevented the family from participating, 373 infants were eligible for the study. Of these, we were unable to schedule a consent meeting with 56, and consent was withheld by 165. Consent was obtained for 150 infants from 115 families. The infants were block randomized to groups of N = 78, FNI and N = 72, SC. Sixteen (9.6%) of the randomized infants did not complete the study to home discharge, 7% of those randomized to SC and 12% of FNI infants. Mothers in the intervention group engaged in 3 to 4 facilitated one- to two-hour sessions/week. Intent to treat analyses revealed no significant difference between groups in medical complications. The mean length of stay was not significantly affected by the intervention.ConclusionThere was no significant effect demonstrated with this intervention amount on the primary short-term outcome, length of stay. FNI can be safely and feasibly implemented within a level IV NICU.Trial registrationClinicaltrials.gov: NCT01439269

Highlights

While survival rates for preterm infants have increased, the risk for adverse long-term neurodevelopmental and behavioral outcomes remains very high
These participation exclusions included: discharge was anticipated in 10 days or less (117), family was moving out of the area and would not be able to participate in follow-up (20), attending physician did not approve approach to consent (18), infant died (3), infant was enrolled in another study that precluded second enrollment (1)
While we found no impact of Family Nurture Intervention (FNI) upon Length of Stay (LOS), the primary outcome of this trial, we did find that the intervention was safe and feasible to implement within a high-acuity, level IV Neonatal Intensive Care Unit (NICU) environment

Summary

Introduction

While survival rates for preterm infants have increased, the risk for adverse long-term neurodevelopmental and behavioral outcomes remains very high. In response to the need for novel, evidence-based interventions that prevent such outcomes, we have assessed Family Nurture Intervention (FNI), a novel dual mother-infant intervention implemented while the infant is in the Neonatal Intensive Care Unit (NICU). The risks for long-term adverse neurodevelopmental and behavioral outcomes remain unacceptably high. These include attention deficits [1], executive dysfunction [2,3], depression and psychotic disorders [4], and autism spectrum disorder [5]. For a variety of reasons that may include cost of implementation, demand on resources, insufficient evidence for long-term effectiveness and resistance to change, these NICU interventions have yet to be universally adopted

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Conclusion