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Limited Versus Extended Trophic Feeding (LET-FEED) Trial

RecruitingPhase 2, Phase 3Ages 0 Years - 2 YearsAllUniversity of Washington
NCT06893939 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. These infants will be randomly assigned to either the intervention group, receiving limited trophic feeding (20 to 25 mL/kg/day for one day) or the control group, receiving extended trophic feeding (20 to 25 mL/kg/day for three days) prior to advancing enteral feeds until full feeding volume (140 mL/kg/day) is achieved. Eligibility Criteria Preterm infants with gestational ages between 25 0/7 and 31 6/

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📋 Eligibility rules (as published)
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
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What it tests

  • Limited Trophic Feeds (1 day of trophic feeds)
  • Extended Trophic Feeds (3 days of trophics)
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Where

6 sites
University of Alabama at Birmingham
Birmingham, United States
University of South Florida
Tampa, United States
University of Oklahoma
Oklahoma City, United States
Baylor College of Medicine
Houston, United States
University of Washington
Seattle, United States
St. Joseph's Medical Center
Tacoma, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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