NCT06893939: LET-FEED

Limited Versus Extended Trophic Feeding (LET-FEED) Trial

Recruiting now Phase 3 Last updated 28 July 2025

What this trial tests

Phase 3 trial testing Limited Trophic Feeds (1 day of trophic feeds) in Sepsis in 350 participants. Currently enrolling.

Timeline

3 July 2025

Primary endpoint
1 January 2028

31 March 2028

Quick facts

Lead sponsor	University of Washington
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	350
Start date	3 July 2025
Primary completion	1 January 2028
Estimated completion	31 March 2028
Sites	6 locations across United States

Drugs / interventions tested

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

Conditions studied

• Sepsis — all drugs for Sepsis →
• Length of Stay — all drugs for Length of Stay →
• Mortality — all drugs for Mortality →

Sponsor

University of Washington

Who can join

Adults 0 Hours to 36 Hours, any sex, with Sepsis or Length of Stay. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.