Family Nurture Intervention in the NICU at The Valley Hospital



Status:Recruiting
Conditions:Women's Studies, Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:6/3/2018
Start Date:October 20, 2017
End Date:November 30, 2019
Contact:Mai Mitsuyama, BA
Email:mm4584@cumc.columbia.edu
Phone:212-342-4400

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The purpose of this study is to compare neurodevelopment and activity in infants born 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 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 30 infants and their mothers

- Phase 2 - Examine effectiveness by implementing FNI unit-wide so that every baby
receives the intervention Approximately 30 infants and their mothers

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.

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
We found this trial at
2
sites
223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
Principal Investigator: Christiane Farkouh-Karoleski, MD
Phone: 646-831-8003
The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
?
mi
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Ridgewood, NJ
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3959 Broadway
New York, New York 10032
Principal Investigator: Martha G Welch, MD
Phone: 212-342-4400
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mi
from
New York, NY
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