Status:
COMPLETED
Family Nurture Intervention in the NICU at The Valley Hospital
Lead Sponsor:
Columbia University
Conditions:
Premature Birth
Obstetric Labor, Premature
Eligibility:
All Genders
26-34 years
Phase:
NA
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...
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 emotion...
Eligibility Criteria
Inclusion
- For the Standard Care and FNI Groups
- infant is between 26 and 33 6/7 weeks gestational age upon admission
- infant is a singleton or twin
Exclusion
- 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
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03267043
Start Date
October 20 2017
End Date
July 1 2020
Last Update
February 15 2023
Active Locations (2)
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1
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
2
Morgan Stanley Children's Hospital of New York (MSCHONY)
New York, New York, United States, 10032