Clinical trial NCT03267043: Family Nurture Intervention in the NICU at The Valley Hospital
Official title: Family Nurture Intervention in the NICU at The Valley Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Obstetric Labor, Premature
Keywords: preterm birth
NICU
neonatal
skin to skin
kangaroo care
separation stress
family nurture
maternal confidence
maternal competence
calming cycle
infant neurodevelopment
infant psychological development
mother-infant co-regulation
postpartum depression
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 150
Sex: ALL
Minimum age (years): 26
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare neurodevelopment and activity in infants born preterm (25 to 34 1/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU).

The investigators hypothesize 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 two-phase effectiveness study aims to:

* Phase 1 - Examine the existing Standard Care Approximately 35 infants and their mothers
* Phase 2 - Examine effectiveness by implementing FNI unit-wide so that every baby receives the intervention Approximately 35 infants and their mothers

Detailed description: This study aims to build upon the findings of the earlier randomized controlled trial (RCT) conducted at the Columbia University Medical Center (CUMC) comparing effects, both physiological and emotional, of the current standard method of encouraging contact between mothers and their babies in the NICU with the more specific approach of Family Nurture Intervention (FNI). In addition to receiving standard care, NICU families assigned to FNI received added intervention that focused on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay.

The investigators wish to conduct an effectiveness trial to evaluate if the family nurture intervention's findings can be replicated on a unit-wide level. This effectiveness trial will take place over two parts. There will be two groups; standard care (SC) and intervention (FNI). Phase 1 of the effectiveness study will evaluate the standard care (SC) group in the unit as a baseline measurement and point of comparison to determine if unit-wide FNI reproduces its prior findings (Phase 2). The standard care group (Phase 1) will receive the current standard of care in the NICU. In Phase 2, FNI will be implemented unit-wide, but infants born between 26 weeks and 0 days to 33 weeks 6 days gestation will be eligible to be enrolled into the study. In addition to receiving standard care, patients enrolled during phase 2 will receive added interventions from the trained FNI nursing staff. These added interventions will include supporting the parents and facilitating contact between mother and infant during their infant's NICU stay.

Eligibility criteria: For the Standard Care and FNI Groups

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

Primary outcomes:
measure: EEG Power in the frontal polar region
timeFrame: Up to 41 weeks gestational age
Secondary outcomes:
measure: EEG Coherence in the left frontal polar to right frontal polar region
timeFrame: Up to 41 weeks gestational age
measure: CES-D Score
timeFrame: Up to 18 months
measure: State-Trait Anxiety Inventory (STAI) Score
timeFrame: Up to 18 months
measure: Neurobehavioral Assessments of Infants - Bayley Scales or Infant and Toddler Development, Bayley III
timeFrame: Up to 18 months
Other outcomes:
measure: Welch Emotional Connection Scale
timeFrame: Up to 18 months
measure: Child Behavior Checklist Score
timeFrame: Up to 18 months
measure: Modified Checklist for Autism in Toddlers (M-CHAT) Score
timeFrame: Up to 18 months
Locations:
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Morgan Stanley Children's Hospital of New York (MSCHONY)
state: New York
Study officials:
affiliation: Columbia University
name: Martha G Welch, MD
role: PRINCIPAL_INVESTIGATOR
References: