Status:
RECRUITING
Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants
Lead Sponsor:
Crouse Hospital
Conditions:
Poor Growth in Extremely Preterm Infants
Necrotizing Enterocolitis
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief Summary
The aim of the project is to study the effects of fortification (using a Human Milk Donor Fortifier) of an exclusive preterm human milk diet on outcome of extremely preterm neonates, born at less or e...
Detailed Description
II. BACKGROUND Necrotizing enterocolitis (NEC) is a serious gastrointestinal disease affecting \>10% of extremely preterm infants with a mortality of up to 50%. The pathophysiology is poorly understoo...
Eligibility Criteria
Inclusion
- All extremely preterm infants with gestational age less or equal to 27 weeks who are admitted to the NICU prior to day of life seven and the first enteral feeding
Exclusion
- Infants with severe congenital anomalies such as chromosomal trisomy, congenital heart disease, and abdominal wall defect
Key Trial Info
Start Date :
February 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04284280
Start Date
February 15 2020
End Date
February 1 2027
Last Update
February 13 2023
Active Locations (1)
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1
Crouse Hospital
Syracuse, New York, United States, 13210