Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT01439269
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2011-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Family Nurture Intervention (FNI) in Neonatal Intensive Care Unit (NICU)
Sponsor:
Columbia University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: