Status:
TERMINATED
Targeted Breast Milk Fortification for Very Low Birth Weight Infants in the NICU
Lead Sponsor:
MetroHealth Medical Center
Conditions:
Human Milk
Neonate
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief Summary
This study evaluates the effectiveness of individualized human milk fortification for very low birth weight (\<1500 g) babies in the NICU (Neonatal Intensive Care Unit) to optimize their growth. Breas...
Detailed Description
Human milk has a variety of benefits for neonates, especially premature neonates, including a decreased risk of for necrotizing enterocolitis, sudden infant death syndrome (SIDS), respiratory syncytia...
Eligibility Criteria
Inclusion
- Premature infants \<1500 g
- Mother consenting to provide breast milk or use of donor breast milk
Exclusion
- Infants with major congenital malformations
- Infants with medical conditions precluding them from having breast milk
- Mothers with medical conditions that preclude them form providing breast milk
- Insufficient breast milk supply
- Refusal of donor breast milk
- Mother is non-English speaking
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04025021
Start Date
October 1 2019
End Date
March 31 2021
Last Update
February 23 2023
Active Locations (1)
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1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109