NCT06893939 · University of Washington
Limited Versus Extended Trophic Feeding (LET-FEED) Trial
(LET-FEED)
What this study is about
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-cause late onset sepsis (LOS) without increasing the risk of other adverse outcomes.
View original scientific description
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-cause late onset sepsis (LOS) without increasing the risk of other adverse outcomes. Study Design Type This is a multi-center, open-label, parallel-group, individual randomized controlled trial comparing two different trophic feeding regimens in preterm infants born between 25w0d and 31w6d.
Interventions
OTHER
Limited Trophic Feeds (1 day of trophic feeds)
Advancing enteral feeds after 1 day of trophic feeds of 20-25 mL/kg birthweight/day. Advancement of enteral feeds will be by approximately 30 mL/kg birthweight/day until achieving at least 140 mL/kg birthweight/day of enteral feeds. Enteral feeds will consist of parent's own milk or donor human milk.
OTHER
Extended Trophic Feeds (3 days of trophics)
Advancing enteral feeds after 3 days of trophic feeds of 20-25 mL/kg birthweight/day. Advancement of enteral feeds will be by approximately 30 mL/kg birthweight/day after 3 days of trophic feeds. Advancement will occur until achieving at least 140 mL/kg birthweight/day of enteral feeds. Enteral feeds will consist of parent's own milk or donor human milk.
Primary outcome measures
Late Onset Sepsis
Time frame: Through study completion, the end of NICU hospitalization, an average of 40 weeks' gestation
Defining LOS: For the purposes of this study, a positive finding of LOS will be defined as the following: a body fluid culture (e.g. blood, urine, CSF) that returns positive, obtained in the presence of compatible clinical signs of sepsis (e.g. hypotension, apnea/bradycardia, increasing oxygen requirements, increasing metabolic acidosis, lactic acidosis, hypoglycemia, hyperglycemia, etc.) occurring after 72 hours from birth and before hospital discharge that was treated with antibiotics for a minimum of 5 days.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \<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 criteria
- \<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
Where
- Birmingham, Alabama
- Tampa, Florida
- Oklahoma City, Oklahoma
- Houston, Texas
- Seattle, Washington
- Tacoma, Washington
Collaborators
University of Alabama at Birmingham, Baylor College of Medicine, University of South Florida, University of Oklahoma, St. Joseph's Medical Center
Related conditions & keywords
Frequently asked questions
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Will I receive a placebo instead of treatment?
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Data: ClinicalTrials.gov · synced Jul 28, 2025 · Source of record for eligibility and locations