NCT06893939 Limited Versus Extended Trophic Feeding (LET-FEED) Trial
| NCT ID | NCT06893939 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Washington |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2025-07-03 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 350 participants in total. It began in 2025-07-03 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-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 6/7 weeks and a birthweight of \<1500 grams who are admitted to six participating neonatal units will be eligible for inclusion. Infants with \<5th percentile for weight at birth, vasopressor use within first 24 hours of life major congenital/genetic anomalies affecting enteral feeding, growth, or mortality, and those with a terminal illness in which decisions to withhold or limit support have been made will be excluded. Infants of parents or legal guardians who are unable to provide consent within 36 hours of birth will also be excluded. Study Intervention/Methods Written parental informed consent will be obtained prenatally or within the first 36 hours of birth. Infants will be randomized to receive limited trophic feeds of 24 to 36 hours or extended trophic feeds for 72 hours prior to the advancement of enteral feeds. Infants will be fed parent's own milk (POM) with donor human milk as the alternative if POM is unavailable. Primary Outcome Late-onset sepsis, defined as positive blood, urine, and/or cerebrospinal fluid (CSF) cultures in the presence of compatible clinical signs of sepsis, occurring after postnatal day 3 and before hospital discharge, and treated with antibiotics for 5 days or more. Secondary Outcome(s) The trial will assess various secondary outcomes including length of hospital stay, all-cause in-hospital mortality, duration of IV fluids and central line utilization, necrotizing enterocolitis (Bell's stage IIa or higher), severe intraventricular hemorrhage (grade III or IV either unilaterally or bilaterally), bronchopulmonary dysplasia (oxygen requirement or positive pressure ventilation at 36 weeks corrected gestational age), or retinopathy of prematurity requiring intervention. Additionally, growth metrics throughout hospitalization will be evaluated using change in weight, length, and head circumference z-scores from birth to 36 weeks' corrected gestational age between infants in the limited and extended trophic feeding groups.
Eligibility 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
Contact & Investigator
Gregory C Valentine
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT06893939 clinical trial?
This trial is open to participants of all sexes, aged 0 Hours or older, up to 36 Hours, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06893939 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 350 participants.
Is NCT06893939 currently recruiting?
Yes, NCT06893939 is actively recruiting participants. Contact the research team at gcvalent@uw.edu for enrollment information.
Where is the NCT06893939 trial being conducted?
This trial is being conducted at Birmingham, United States, Tampa, United States, Oklahoma City, United States, Houston, United States and 2 additional locations.
Who is sponsoring the NCT06893939 clinical trial?
NCT06893939 is sponsored by University of Washington. The principal investigator is Gregory C Valentine at University of Washington. The trial plans to enroll 350 participants.