Limited versus extended trophic feeding for very preterm infants
Limited Versus Extended Trophic Feeding (LET-FEED) Trial
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 | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 0 Hours to 36 Hours |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 6 sites (Birmingham, Alabama and 5 other locations) |
| Trial ID | NCT06893939 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Birmingham, Alabama and 5 other locations
- 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)
- St. Joseph's Medical Center — Tacoma, Washington, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.