Clinical trial NCT02710474: Family Nurture Intervention in the NICU
Official title: Family Nurture Intervention in the NICU: A Multi-Site Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Obstetric Labor, Premature
Keywords: preterm birth
NICU
neonatal
kangaroo care
separation stress
family nurture
maternal confidence
maternal competence
calming cycle
infant neurodevelopment
infant psychological development
mother-infant co-regulation
post-partum depression
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Einhorn Family Charitable Trust
First posted: 2016-03-16
Enrollment: 461
Sex: ALL
Minimum age (years): 26
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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

Detailed 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 Within the NICU, parental involvement in care is necessarily superseded by the healthcare staff's need to assure survival.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.

Eligibility criteria: For the FNI and SC Groups (enrolled competitively at across all participating sites)

Inclusion criteria:

* Infant is between 26 and 33 6/7 weeks gestational age upon admission
* Infant is a singleton or twin

Exclusion criteria:

* Infant's attending physician does not recommend enrollment in the study
* Severe congenital anomalies including chromosomal anomalies
* Ultrasound evidence of large parenchymal hemorrhagic infarction (\>2 cm, intraventricular hemorrhage grade 3 or 4)
* Infant cardiac anomalies
* Mother has known history of substance abuse, severe psychiatric illness or psychosis
* Status of enrolled subject changes and subject now falls into exclusion criteria
* Mother and/or infant has a medical condition that precludes intervention components
* Mother and/or infant has a contagion that endangers other participants in the study

For the TC Group (enrolled at one site: MSCHONY)

Inclusion Criteria:

* Infant is born between 38-42 weeks gestation
* Infant is singleton or twin

Exclusion criteria:

* Infant's attending physician does not recommend enrollment in the study
* Severe congenital anomalies including chromosomal anomalies
* Ultrasound evidence of large parenchymal hemorrhagic infarction (\>2 cm, intraventricular hemorrhage grade 3 or 4)
* Infant cardiac anomalies
* Mother has known history of substance abuse, severe psychiatric illness or psychosis
* Status of enrolled subject changes and subject now falls into exclusion criteria
* Mother and/or infant has a medical condition that precludes intervention components
* Mother and/or infant has a contagion that endangers other participants in the study

Primary outcomes:
measure: EEG Power in the frontal polar region
timeFrame: Infant Age at 39-41 Weeks gestational age
Secondary outcomes:
measure: EEG Coherence in the left frontal polar to right frontal polar region
timeFrame: Infant Age at 39-41 Weeks gestational age
measure: CES-D Score
timeFrame: Up to 18 months
measure: STAI Score
timeFrame: Up to 18 months
measure: Neurobehavioral Assessment of Infants - Bayley Scales of Infant and Toddler Development, Bayley III
timeFrame: 18 Month corrected age Follow-Up
Other outcomes:
measure: Welch Emotional Connection Scale
timeFrame: Up to 18 months
measure: Child Behavior Checklist Score
timeFrame: 18 Month corrected age Follow-Up
measure: Modified Checklist for Autism in Toddlers (M-CHAT) Score
timeFrame: 18 Month corrected age Follow-Up
Locations:
city: New York
country: United States
facility: Morgan Stanley Children's Hospital of New York (MSCHONY)
state: New York
city: San Antonio
country: United States
facility: University Texas Health Science Center San Antonio (UTHSCSA)
state: Texas
Study officials:
affiliation: CUMC
name: Martha G Welch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Helle N, Barkmann C, Bartz-Seel J, Diehl T, Ehrhardt S, Hendel A, Nestoriuc Y, Schulte-Markwort M, von der Wense A, Bindt C. Very low birth-weight as a risk factor for postpartum depression four to six weeks postbirth in mothers and fathers: Cross-sectional results from a controlled multicentre cohort study. J Affect Disord. 2015 Jul 15;180:154-61. doi: 10.1016/j.jad.2015.04.001. Epub 2015 Apr 10.
citation: Robbins CL, Hutchings Y, Dietz PM, Kuklina EV, Callaghan WM. History of preterm birth and subsequent cardiovascular disease: a systematic review. Am J Obstet Gynecol. 2014 Apr;210(4):285-297. doi: 10.1016/j.ajog.2013.09.020. Epub 2013 Sep 18.
citation: Holditch-Davis D, Bartlett TR, Blickman AL, Miles MS. Posttraumatic stress symptoms in mothers of premature infants. J Obstet Gynecol Neonatal Nurs. 2003 Mar-Apr;32(2):161-71. doi: 10.1177/0884217503252035.
citation: Welch MG, Grieve PG, Stark RI, Isler JR, Ludwig RJ, Hane AA, Gong A, Darilek U, Austin J, Myers MM. Family nurture intervention increases term age forebrain EEG activity: A multicenter replication trial. Clin Neurophysiol. 2022 Jun;138:52-60. doi: 10.1016/j.clinph.2022.02.018. Epub 2022 Mar 5.