RecruitingNot ApplicableNCT04284280

Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants


Sponsor

Crouse Hospital

Enrollment

200 participants

Start Date

Feb 15, 2020

Study Type

INTERVENTIONAL

Conditions

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 equal to 27 weeks.


Eligibility

Min Age: 0 DaysMax Age: 6 Days

Inclusion Criteria1

  • 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 Criteria1

  • Infants with severe congenital anomalies such as chromosomal trisomy, congenital heart disease, and abdominal wall defect

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Interventions

DIETARY_SUPPLEMENTRoutine vs Selective use of Human Milk Donor Fortifier

Infants will be randomized to two groups. Both groups will be fed Premature Human Milk (either Maternal own milk or Premature donor human milk). However, one group will get fortified with Donor Human Milk Fortifier once full feed is reached while the second group will get fortified using the same fortifier only when weight gain is suboptimal.


Locations(1)

Crouse Hospital

Syracuse, New York, United States

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NCT04284280


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