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NCT06893939 · ClinicalTrials.gov registry record · Phase 3
Limited Versus Extended Trophic Feeding (LET-FEED) Trial
A Phase 3 study of Sepsis and Mortality, sponsored by University of Washington.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
- 6
- Study locations
NCT06893939 is a Phase 3 study of Sepsis and Mortality that is actively recruiting participants, run by University of Washington. The registered enrollment target is 350 participants, below the 6,561-participant average among 90 other Sepsis trials with a reported enrollment target (95% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT06893939, a Phase 3 study of Sepsis and Mortality, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
- 6
- Study locations
Study 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
Conditions Studied
Interventions
- OTHER Limited Trophic Feeds (1 day of trophic feeds)
- OTHER Extended Trophic Feeds (3 days of trophics)
Study Locations (6)
Washington
- University of Washington - Seattle
- St. Joseph's Medical Center - Tacoma
Alabama
- University of Alabama at Birmingham - Birmingham
Florida
- University of South Florida - Tampa
Oklahoma
- University of Oklahoma - Oklahoma City
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2025-07-03 |
| Est. Completion | 2028-03-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06893939
The ClinicalTrials.gov registry entry for NCT06893939 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,561-participant average among 90 other Sepsis trials with a reported enrollment target (95% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Sepsis appearing as the primary indexed condition, and to 2 interventions - of which Limited Trophic Feeds (1 day of trophic feeds) is the first listed.
NCT06893939 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Washington, Alabama, Florida.
Frequently Asked Questions
What is clinical trial NCT06893939 about?
NCT06893939 is a clinical study titled "Limited Versus Extended Trophic Feeding (LET-FEED) Trial". 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 ...
What is the current status of trial NCT06893939?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2025-07-03. Estimated completion is 2028-03-31.
What conditions does trial NCT06893939 study?
This clinical trial studies the following conditions: Sepsis, Mortality, Length of Stay.
What interventions are being tested in trial NCT06893939?
The interventions under investigation include: Limited Trophic Feeds (1 day of trophic feeds) (OTHER), Extended Trophic Feeds (3 days of trophics) (OTHER).
Who is sponsoring clinical trial NCT06893939?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06893939 being conducted?
This trial has 6 study locations across Alabama, Florida, Oklahoma, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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