Family Nurture Intervention in the NICU at The Valley Hospital
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- EEG Power in the frontal polar region
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 26 Weeks to 34 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Arms & Interventions
Standard Care
Participants enrolled in Phase 1 will be receiving the current standard of care in the NICU at The Valley Hospital.
Intervention: Standard Care (Behavioral)
Family Nurture Intervention (FNI)
Participants enrolled in Phase 2 will be receiving family nurture intervention (FNI) that focuses on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay.
Intervention: Family Nurture Intervention (FNI) (Behavioral)
Standard Care - Case Studies
Participants enrolled as case studies in Phase 1 will be receiving the current standard of care in the NICU at The Valley Hospital. These participants will be those who fall outside the inclusion criteria.
Intervention: Standard Care (Behavioral)
FNI - Case Studies
Participants enrolled in Phase 2 will be receiving family nurture intervention (FNI) that focuses on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay. These fall outside the inclusion criteria but act as a comparator to the case studies of Phase 1.
Intervention: Family Nurture Intervention (FNI) (Behavioral)
Outcomes
Primary Outcomes
EEG Power in the frontal polar region
Time Frame: Up to 41 weeks gestational age
Measured in microvolts (µV)\^2 for infants.
Secondary Outcomes
- State-Trait Anxiety Inventory (STAI) Score(Up to 18 months)
- Neurobehavioral Assessments of Infants - Bayley Scales or Infant and Toddler Development, Bayley III(Up to 18 months)
- EEG Coherence in the left frontal polar to right frontal polar region(Up to 41 weeks gestational age)
- CES-D Score(Up to 18 months)
Investigators
Martha G Welch
Associate Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)
Columbia University