Clinical trial NCT01439269: Family Nurture Intervention (FNI) in Neonatal Intensive Care Unit (NICU)
Official title: Enhancement of Co-regulation Between Mother and Infant Via Family Nurture Intervention (FNI) in the NICU: Short and Long Term Effects on Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: Separation stress
Family Nurture
Maternal Confidence
Maternal Competence
Calming Cycle
Kangaroo Care
Infant Neurodevelopment
Infant Psychological Development
Post-partum depression
Mother-infant Co-regulation
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Williams College
name: New York State Psychiatric Institute
First posted: 2011-09-23
Enrollment: 394
Sex: ALL
Minimum age (years): 26
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the efficacy of a family nurture intervention in the neonatal intensive care unit (NICU). Infants receiving enhanced mother-infant and family nurture are compared to infants receiving standard NICU care. The intervention enhances mother/infant interactions that are vital to early development in the infant. The main goal is to get the mother and infant into biological synchrony, emotional attunement and mutual calm through an activity referred to as a "calming cycle". Mother's are encouraged to engage in the calming cycle activities as much as possible. Her increased effectiveness in calming her infant is hypothesized to improve the mother's view of her baby, reduce negative emotions about having delivered a baby prematurely, and help her gain confidence in her care-taking abilities, which in other studies predicted shorter length of stay and fewer re-hospitalizations. Another goal is to assist mothers in repeating the calming cycle activities providing appropriate types of stimulation for their babies that are important for social, emotional, and neurobehavioral development. Since preterm babies are often easily upset, mothers will be taught how to comfort and calm their babies. Assessments in the NICU and in follow-up visits for two years will test the immediate and long-term effects of this new approach to the nurture of prematurely born infants.

Detailed description: The stress that results from preterm birth, requisite acute care and prolonged physical separation in the NICU can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of an optimal mother-infant relationship. Within the neonatal intensive care unit (NICU), parental involvement in care is necessarily superseded by the healthcare staff. Thus, a necessary but detrimental separation between mother and infant is created at a critical period when mother-infant bonding 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. This study aims to highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges by implementing a randomized controlled trial of Family Nurture Intervention in the NICU. The most important source of regulatory input is through contact with the mother and her nurturing behavior. Mother-infant interactions are the foundation for the organization of the infant's neurobiological, sensory, perceptual, emotional, physical, and relational systems. The infant's responses to the mother provide critical feedback which shapes her behavior as well. There are many co-regulatory processes embedded in these synchronous and reciprocal interactions which cross neurophysiological and neurobehavioral domains. The intervention is designed to increase biologically important activities and behaviors that enhance maternally-mediated sensory experiences of preterm infants, as well as the infant-mediated sensory experiences in the mother. The investigators hypothesize that repeated engagement of the mother and her infant in the intervention's calming activities will increase the effectiveness of co-regulation and have immediate and long-term beneficial effects for both. The study is assessing the physiological and behavioral outcomes of the infants and mothers receiving Family Nurture Intervention versus Standard Care over the course of the NICU stay.

Eligibility criteria: Inclusion Criteria:

* Infant is born a singleton or twin in the Morgan Stanley Children's Hospital in New York City
* Infant is born 26 and 34 weeks post-conceptional age (PCA)

Exclusion Criteria:

* Mothers cannot understand or speak English
* Mother has history of drug addiction, psychosis or other severe mental illness
* There is not at least one adult other than the mother in the home
* Infant birth weight is below the third percentile for gestational age
* Infant has significant congenital defects

Primary outcomes:
measure: Length of Stay
timeFrame: From Infant's birth to discharge from NICU
Secondary outcomes:
measure: Safety and Practicability of Intervention
timeFrame: up to 5 years
measure: Psychological Assessments: Mothers in both groups are given a wide-range of psychological questionnaires. These include indices of anxiety, depression, temperament, personality, attachment, stress, and social support.
timeFrame: Up to 24 months of Age
measure: Neurobehavioral Assessments of Infants: The use of the NICU Network Neurobehavioral Scale (NNNS) to assess infant's neurodevelopmental status
timeFrame: Up to 40 weeks Gestational Age
measure: Neurobehavioral Assessments of Infants: Mothers provide a wide range of information about infant's development through questionnaires
timeFrame: Up to 24 months corrected age
measure: Neurobehavioral Assessments of Infants- Bayley Scales of Infant and Toddler Development, Bayley III
timeFrame: Up to 24 months corrected age
measure: Physiological Assessments: A one hour recording of high density electroencephalogram (EEG) (128 leads), electrocardiogram (ECG), and respiration during sleep.
timeFrame: Up to 42 weeks post-conceptional age
measure: Physiological Assessments- Cortisol Levels, breast milk, saliva, infant blood samples, and infant stool collection
timeFrame: Up to 24 months corrected age
measure: Mother-Infant Interactions Assessments: Evaluating the qualities of the mother's interaction with her infant during diaper change
timeFrame: Up to 4 months corrected age
measure: Mother-Infant Interaction Assessments: Mother-infant face-to-face communicative competence, sensitivity of maternal caregiving and mother and infant physiological capacity to cope with a stressor
timeFrame: Up to 24 months corrected age
measure: Mother-Infant Interaction Assessments- Yale Inventory of Parental Thoughts and Actions (YIPTA)
timeFrame: up to 24 months corrected age
measure: Assessments of Neonatal Intensive Care Unit Activities: Ascertainment of attendance and the frequency and/or time spent engaged in key aspects of the Family Nurture Intervention using maternal self-report forms.
timeFrame: Participants will be followed for the duration of NICU stay, an expected average of 7 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Morgan Stanley Children's Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Martha G Welch, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Welch MG, Barone JL, Porges SW, Hane AA, Kwon KY, Ludwig RJ, Stark RI, Surman AL, Kolacz J, Myers MM. Family nurture intervention in the NICU increases autonomic regulation in mothers and children at 4-5 years of age: Follow-up results from a randomized controlled trial. PLoS One. 2020 Aug 4;15(8):e0236930. doi: 10.1371/journal.pone.0236930. eCollection 2020.
citation: Beebe B, Myers MM, Lee SH, Lange A, Ewing J, Rubinchik N, Andrews H, Austin J, Hane A, Margolis AE, Hofer M, Ludwig RJ, Welch MG. Family nurture intervention for preterm infants facilitates positive mother-infant face-to-face engagement at 4 months. Dev Psychol. 2018 Nov;54(11):2016-2031. doi: 10.1037/dev0000557. Epub 2018 Oct 4.
citation: Hane AA, Myers MM, Hofer MA, Ludwig RJ, Halperin MS, Austin J, Glickstein SB, Welch MG. Family nurture intervention improves the quality of maternal caregiving in the neonatal intensive care unit: evidence from a randomized controlled trial. J Dev Behav Pediatr. 2015 Apr;36(3):188-96. doi: 10.1097/DBP.0000000000000148.
citation: Welch MG, Hofer MA, Stark RI, Andrews HF, Austin J, Glickstein SB, Ludwig RJ, Myers MM; FNI Trial Group. Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety. BMC Pediatr. 2013 Sep 24;13:148. doi: 10.1186/1471-2431-13-148.
citation: Welch MG, Hofer MA, Brunelli SA, Stark RI, Andrews HF, Austin J, Myers MM; Family Nurture Intervention (FNI) Trial Group. Family nurture intervention (FNI): methods and treatment protocol of a randomized controlled trial in the NICU. BMC Pediatr. 2012 Feb 7;12:14. doi: 10.1186/1471-2431-12-14.