Limited Versus Extended Trophic Feeding (LET-FEED) Trial

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Maximum Age: 1 day
Healthy Volunteers: t
View:

• \<1500 gram birthweight

• 25w0d-31w6d at birth

• Consent to feed donor milk when parent's own milk is not available or of insufficient quantity

Locations
United States
Alabama
University of Alabama at Birmingham
NOT_YET_RECRUITING
Birmingham
Florida
University of South Florida
NOT_YET_RECRUITING
Tampa
Oklahoma
University of Oklahoma
NOT_YET_RECRUITING
Oklahoma City
Texas
Baylor College of Medicine
NOT_YET_RECRUITING
Houston
Washington
University of Washington
NOT_YET_RECRUITING
Seattle
St. Joseph's Medical Center
RECRUITING
Tacoma
Contact Information
Primary
Gregory C Valentine, MD MED FAAP
gcvalent@uw.edu
(206) 543-3200
Backup
Ariel Salas, MD, MSPH
asalas@uabmc.edu
Time Frame
Start Date: 2025-07-03
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 350
Treatments
Active_comparator: Extended Trophic Feeding
Advancing enteral feeds after 3 days of trophic feeds of 20-25 mL/kg birthweight/day. Advancement of enteral feeds will be by approximately 30 mL/kg birthweight/day after 3 days of trophic feeds. Advancement will occur until achieving at least 140 mL/kg birthweight/day of enteral feeds. Enteral feeds will consist of parent's own milk or donor human milk.
Experimental: Limited Trophic Feeds
Advancing enteral feeds after 1 day of trophic feeds of 20-25 mL/kg birthweight/day. Advancement of enteral feeds will be by approximately 30 mL/kg birthweight/day until achieving at least 140 mL/kg birthweight/day of enteral feeds. Enteral feeds will consist of parent's own milk or donor human milk.
Sponsors
Collaborators: University of South Florida, St. Joseph's Medical Center, University of Oklahoma, University of Alabama at Birmingham, Baylor College of Medicine
Leads: University of Washington

This content was sourced from clinicaltrials.gov