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Open Access Highly Accessed Study protocol

Family nurture intervention (FNI): methods and treatment protocol of a randomized controlled trial in the NICU

Martha G Welch123*, Myron A Hofer1, Susan A Brunelli1, Raymond I Stark2, Howard F Andrews4, Judy Austin4, Michael M Myers125 and the Family Nurture Intervention (FNI) Trial Group1256

Author Affiliations

1 Department of Psychiatry, College of Physicians & Surgeons, 1051 Riverside Drive Unit 40, New York, NY 10032, USA

2 Department of Pediatrics, College of Physicians & Surgeons, 630 West 168th Street, New York, NY, 10032, USA

3 Department of Pathology & Cell Biology, College of Physicians & Surgeons, 630 West 168th Street, New York, NY, 10032, USA

4 Mailman School of Public Health, Columbia University, 722 West 168th Street, New York, NY, 10032, USA

5 Department of Psychiatry, New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10032, USA

6 Department of Psychology, Bronfman Science Center, Williams College, 18 Hoxsey Street, Williamstown, MA, 01267, USA

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BMC Pediatrics 2012, 12:14  doi:10.1186/1471-2431-12-14

Published: 7 February 2012

Abstract

Background

The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU) can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges.

Methods

This study is a randomized controlled trial (RCT) with blinded assessment comparing Standard Care (SC) with a novel Family Nurture Intervention (FNI). FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA) and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1) In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2) Outside the isolette during holding and feeding via the Calming Cycle; and 3) through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA), maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group).

Discussion

The FNI is designed to increase biologically important activities and behaviors that enhance maternally-mediated sensory experiences of preterm infants, as well as infant-mediated sensory experiences of the mother. Consequently, we are enlarging the testing of preterm infant neurodevelopment beyond that of previous research to include outcomes related to mother-infant interactions and mother-infant co-regulation. Our primary objective is to determine whether repeated engagement of the mother and her infant in the intervention's calming activities will improve the infant's developmental trajectory with respect to multiple outcomes. Our secondary objective is to assess the effectiveness of FNI in the physiological and psychological co-regulation of the mother and infant. We include aspects of neurodevelopment that have not been comprehensively measured in previous NICU interventions.

Trial Registration

ClinicalTrials.gov: NCT01439269