Limited versus extended trophic feeding for very preterm infants
Official title: Limited Versus Extended Trophic Feeding (LET-FEED) Trial
Run by University of Washington · NCT06893939 · Data updated 2026-11-12
This trial tests whether advancing enteral feeds after 24 hours instead of after 72 hours lowers the risk of late-onset sepsis in very preterm infants born between 25 and 31 weeks.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 0 Years to 2 Years |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | University of Washington Academic / other |
| Locations | 6 sites (Birmingham, Alabama and 5 other locations) |
| Status | Recruiting |
| Started | July 3, 2025 |
| Main results expected | August 30, 2030 |
| Study ends | February 28, 2031 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT06893939 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are very preterm infants born at 25 0/7 to 31 6/7 weeks with birthweight <1500 g, whose parents consent to participate and to use donor milk if needed, and who are admitted to a participating NICU within the enrollment window.
✕Probably not a fit
Infants with major congenital anomalies affecting feeding, known genetic growth disorders, vasopressor use in the first 24 hours, those considered terminally ill, or those <5th percentile for weight are unlikely to benefit from this feeding comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multi-center, open-label, randomized trial comparing two trophic feeding strategies in very preterm infants: a limited approach (20–25 mL/kg/day for one day) versus an extended approach (20–25 mL/kg/day for three days) before advancing to full feeds (140 mL/kg/day). Eligible infants are 25 0/7 to 31 6/7 weeks' gestation with birthweight under 1500 g and will be enrolled and randomized at participating neonatal units. The trial measures all-cause late-onset sepsis as a primary outcome and also tracks length of stay, mortality, and other adverse events. Feeding will use parental milk or donor human milk when needed and supplemental IV nutrition is provided while enteral feeds are advanced.
Why it matters
Potential benefit: If successful, the approach could reduce late-onset sepsis and related complications by shortening IV exposure and getting infants onto full enteral feeds sooner.
How similar studies have gone: Human milk feeding is known to reduce late-onset sepsis risk, but few randomized trials have directly compared 1-day versus 3-day trophic feeding regimens, so the specific timing strategy remains unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
-
St. Joseph's Medical Center
Tacoma, Washington, United States Recruiting -
University of Alabama at Birmingham
Birmingham, Alabama, United States Not yet recruiting -
University of South Florida
Tampa, Florida, United States Not yet recruiting -
University of Oklahoma
Oklahoma City, Oklahoma, United States Not yet recruiting -
Baylor College of Medicine
Houston, Texas, United States Not yet recruiting -
University of Washington
Seattle, Washington, United States Not yet recruiting
Study contacts
- Principal investigator: Gregory C Valentine — University of Washington
- Study coordinator: Gregory C Valentine, MD MED FAAP
- Email: gcvalent@uw.edu
- Phone: (206) 543-3200
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.