The overall goal of our program of research is to test the hypothesis that increasing the amount of specific types of mother-infant and family-calming interactions will improve neurodevelopmental and emotional outcomes in preterm infants, and behavioral and emotional outcomes in mothers.
The stress that results from preterm birth, and the requisite acute care and prolonged physical separation in the NICU, can have adverse physiological/psychological effects on both the infant and the mother [1
]. In particular, the experience compromises the establishment and maintenance of an optimal mother-infant relationship [4
]. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges.
There have been numerous trials of interventions for mothers of preterm infants. However, several aspects make this current study different. Few studies have examined the effectiveness of biologically-relevant mother-infant calming activities in their breadth and complexity using an RCT design. With the exception perhaps of some Kangaroo Care (KC) or Kangaroo Mother Care (KMC) interventions, very few trials incorporate strategies that relate to mother-infant interactions while the infant is in the NICU, even fewer while the infant is confined to the isolette. No such trial to our knowledge has specifically identified the "Calming Cycle" (see Methods and Design below) as the central focus of the intervention, or included an extended family support component for the mother and infant. Few trials have included as extensive an array of physiological and psychological mother and infant outcome measures. Finally, few trials have followed the patients for two years. We seek to address these deficiencies by carrying out an RCT of a family-based nurture intervention (FNI) among the families of pre-term infants born 26-34 weeks PMA into the NICU, using blinded assessments of effectiveness with long-term follow-up.
By nurturing interactions and activities, we mean those mother-infant interactions inherently involved in mothering such as holding, touching and communicating. These activities engage the sensory systems of both the mother and her infant (i.e., sight, hearing, smell, touch, taste, temperature, vestibular, kinesthetic) [7
]. An emerging body of preclinical and clinical evidence is revealing the critical importance of specific mother-infant interactions in regulating the physiology and behavior of the infant [9
], and for shaping the development of their behavior and physiology [11
]. Our intervention is designed to enlist these proximal mechanisms for the improvement of developmental outcome in premature infants.
Nurturing interactions are equally important for establishing and maintaining the mother's physiological and behavioral adaptations necessary for the care of her infant [16
]. Based on the literature and on the extensive clinical experience of the first author, early introduction of repeated mother-infant sensory calming interactions is expected to alleviate maternal depression, anxiety, and guilt, as well as lessen infant aversion to contact that stems from separation/isolation and stressful medical procedures. These sensory calming interactions are expected to have physiological and behavioral effects on both infant and mother, including increasing the mother's feeling of competence. Once the physiology of mother and infant are altered, we hypothesize that these changes will be sustained over time.
We are combining elements of prior interventions with known efficacy and testing these within the theoretic context we call the mother-infant Calming Cycle
. This cycle, which is depicted schematically in Figure , was described by the first author in the 1980's. It was subsequently refined and published as a therapeutic intervention suitable for mothers and children with a wide range of ages and disorders [18
]. In FNI, the Calming Cycle
procedure has been adapted for mothers with preterm infants. In so doing, 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 outcome measures, especially those that measure mother-infant co-regulation, include aspects of neurodevelopment that have not been extensively used in a NICU intervention and never in the integrated way we propose (i.e., mother-infant physiological measures during the Calming Cycle
Figure 1 Conceptual representation of Calming Cycle hypothesis. During a Calming Cycle mothers and infants cycle through: 1) separate mother and infant discomfort/distress, 2) mutually shared distress, 3) mutual resolution of discomfort/distress, 4) mutual calm (more ...)
Our intervention focuses on enabling mothers to engage in certain mother-infant interactions as early as possible after birth, within the constraints of the NICU environment. These interactions begin with odor-cloth exchange, firm sustained touch and vocal soothing, and eye contact while the infant is confined to the isolette; skin-to-skin contact and Calming Cycle activities are added to these as soon as the infant is able to be held and fed by the mother. The intervention also provides other family members with strategies to support the mother as she continues these interactions with her infant within the NICU and at home.
The intervention used in this trial is based on a rich history of ethological and experimental studies in animals and humans, as well as from the 30-year clinical experience of the first author treating developmental disorders. Our approach also draws on existing early intervention literature, including studies on the effectiveness of kangaroo care (KC) [22
], Creating Opportunities for Parent Empowerment (COPE) [25
], and Family Centered Care (FCC) [27
The rationale underlying many of the features of this intervention is also supported by a recent meta-analysis of early NICU interventions involving parents [29
]. The findings of this systematic review show the importance of early intervention and teaching parents skills and/or involving parents in the care of the preterm for enhancing child development. The meta-analysis focused on one primary outcome, broad neurodevelopment, which is one of the primary infant outcome measures of our trial. The prior findings support several key features of FNI: early intervention is critical, greater amounts of intervention are more effective, targeting both mother and infant is important, increasing certain types of physical contact is efficacious, and family support and involvement is of benefit.
The present report describes in detail the FNI methodology and summarizes the measures used to evaluate the efficacy, safety and practicability of this intervention. These assessments include a broad spectrum of infant physiological, infant behavioral and family health outcomes, starting from the time of enrollment in the NICU through the first two years of the infant's life. Our primary objective is to determine the effectiveness of FNI in improving the neurodevelopmental and emotional outcomes in preterm infants. Our secondary objective is to assess the ability of FNI to improve co-regulation in the mother and her preterm infant.