Status:
COMPLETED
Family Nurture Intervention (FNI) in Neonatal Intensive Care Unit (NICU)
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Williams College
New York State Psychiatric Institute
Conditions:
Premature Birth
Eligibility:
All Genders
26-34 years
Phase:
NA
Brief Summary
The purpose of this study is to test the efficacy of a family nurture intervention in the neonatal intensive care unit (NICU). Infants receiving enhanced mother-infant and family nurture are compared ...
Detailed Description
The stress that results from preterm birth, requisite acute care and prolonged physical separation in the NICU can have adverse physiological/psychological effects on both the infant and the mother. I...
Eligibility Criteria
Inclusion
- Infant is born a singleton or twin in the Morgan Stanley Children's Hospital in New York City
- Infant is born 26 and 34 weeks post-conceptional age (PCA)
Exclusion
- Mothers cannot understand or speak English
- Mother has history of drug addiction, psychosis or other severe mental illness
- There is not at least one adult other than the mother in the home
- Infant birth weight is below the third percentile for gestational age
- Infant has significant congenital defects
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2018
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT01439269
Start Date
June 1 2008
End Date
January 9 2018
Last Update
February 15 2023
Active Locations (1)
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1
Morgan Stanley Children's Hospital
New York, New York, United States, 10032