Status:
RECRUITING
Limited Versus Extended Trophic Feeding (LET-FEED) Trial
Lead Sponsor:
University of Washington
Collaborating Sponsors:
University of Alabama at Birmingham
Baylor College of Medicine
Conditions:
Sepsis
Length of Stay
Eligibility:
All Genders
Up to 36 years
Phase:
PHASE3
Brief Summary
Study Hypothesis/Question In infants born very preterm, advancing enteral feeds after 24 hours from birth (limited trophic feeds) versus after 72 hours (extended trophic feeds) reduces the risk of all...
Detailed Description
Up to 30% of all very preterm (VP; defined as those born before 32 weeks' gestation) newborns born within the United States develop late onset sepsis (LOS), a life-threatening infection that occurs af...
Eligibility Criteria
Inclusion
- \<1500 gram birthweight
- 25w0d-31w6d at birth
- Consent to feed donor milk when parent's own milk is not available or of insufficient quantity
Exclusion
- \<5th percentile for weight at birth (Fenton growth curve)
- Parent or legal guardian unable to provide consent within 36 hours after birth
- Congenital anomaly affecting decisions on enteral feedings (e.g. gastroschisis, omphalocele, congenital diaphragmatic hernia, congenital heart disease, etc.)
- Known genetic condition affecting growth, feeding, or mortality
- Vasopressor use within first 24 hours after birth (not including hydrocortisone)
- Considered terminally ill
Key Trial Info
Start Date :
July 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06893939
Start Date
July 3 2025
End Date
March 31 2028
Last Update
July 28 2025
Active Locations (6)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of South Florida
Tampa, Florida, United States, 33606
3
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
4
Baylor College of Medicine
Houston, Texas, United States, 77030