Family Nurture Intervention in the NICU

Status Completed

Clinical Trial Summary

The purpose of this study is to compare neurodevelopment and activity in infants born very preterm (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU). The study investigator hypothesizes that FNI will improve: i) neonatal electroencephalographic activity ii) maternal caregiving and wellbeing (psychological and physiological), and iii) infant behavior and neurodevelopment at 18 months corrected age (CA). The study aims to: - Replicate efficacy from an earlier trial by conducting the study at multiple sites to allow for greater generalizability. - SC, approximately 90 infants plus the parents - FNI, approximately 90 infants plus the parents - Term Controls, approximately 25 infants plus the parents

Clinical Trial Description

Increasing number of studies demonstrating the importance of early mother-infant nurturing interaction on long-term outcomes demonstrates the need for a prevention/remedial intervention in the neonatal intensive care unit (NICU). The foremost goal of neonatal intensive care is to ensure survival and medical stability of the infant. Within the NICU, parental involvement in care is necessarily superseded by the healthcare staff's need to assure survival. Thus, a necessary but detrimental separation between mother and infant is created at a critical period when mother-infant connection 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. Not only are preterm infants at increased risk for adverse outcomes (>50%), but up to 40% of mothers of these infants suffer from depression during the postpartum period and many mothers suffer symptoms of trauma and post-traumatic stress. Importantly, fathers of preterm infants are also at increased for postnatal depression. In addition, a recent review of 10 studies found that mothers of preterm infants are at increased risk for subsequent ischemic heart disease, stroke, atherosclerosis, and death due to cardiovascular disease (CVD). Delivery of a preterm infant has long lasting effects on both parents with both mothers and fathers reporting increased parenting stress when their infants reached 7 years of age. This study will allow examination of the immediate and long-term effects of new approach on the development of preterm infants and cardiovascular risk of their parents. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02710474
Study type	Interventional
Source	Columbia University
Contact
Status	Completed
Phase	N/A
Start date	January 24, 2017
Completion date	December 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05048550` - Babies in Glasses; a Feasibility Study.	N/A
Active, not recruiting	`NCT03655639` - Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
Enrolling by invitation	`NCT05542108` - Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants	N/A
Completed	`NCT03680157` - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed	`NCT03337659` - A Cluster Randomized Controlled Trial of FICare at 18 Months	N/A
Completed	`NCT03649932` - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing	Phase 1
Completed	`NCT03251729` - Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix	Phase 4
Not yet recruiting	`NCT05039918` - Neonatal Experience of Social Touch	N/A
Not yet recruiting	`NCT03418012` - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB	N/A
Not yet recruiting	`NCT03418311` - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome	N/A
Completed	`NCT02952950` - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study	N/A
Completed	`NCT02913495` - Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth	Phase 4
Not yet recruiting	`NCT02880696` - Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates	N/A
Completed	`NCT02661360` - Effects of Swaddling on Infants During Feeding	N/A
Completed	`NCT02743572` - Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants	N/A
Completed	`NCT02879799` - Family Integrated Care (FICare) in Level II NICUs	N/A
Completed	`NCT01352234` - Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia	Phase 4
Completed	`NCT01163188` - Social Adjustment and Quality of Life After Very Preterm Birth	N/A
Terminated	`NCT00675753` - Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families	N/A
Completed	`NCT00271115` - Kangaroo Holding and Maternal Stress	N/A