Trophic Feeding for Sepsis Prevention

(LET-FEED Trial)

Recruiting at 5 trial locations

Overseen By Ariel Salas, MD, MSPH

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Washington

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this 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 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.

Research Team

Gregory C Valentine

Principal Investigator

University of Washington

Eligibility Criteria

The LET-FEED trial is for very preterm infants born between 25 and almost 32 weeks, weighing less than 1500 grams. It's not for those with severe congenital issues affecting feeding or growth, extremely low birth weight, early vasopressor need, or terminal illness where life support is limited.

Inclusion Criteria

My birth weight was less than 1500 grams.

I was born between 25 and 31 weeks of pregnancy.

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

Exclusion Criteria

My baby needed medicine to raise blood pressure within 24 hours of birth.

Parent or legal guardian unable to provide consent within 36 hours after birth

I have a birth defect that affects how I am fed.

Treatment Details

Interventions

• Extended Trophic Feeds (Behavioural Intervention)
• Limited Trophic Feeds (Behavioural Intervention)

Trial Overview This study tests if starting regular feeds after one day (limited trophic feeds) versus three days (extended trophic feeds) affects the risk of late-onset sepsis in very preterm infants without increasing other risks. Infants will be randomly assigned to either group.

Participant Groups

Group I: Limited Trophic Feeds Experimental Treatment 1 Intervention

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.

Group II: Extended Trophic Feeding Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

St. Joseph's Medical Center

Collaborator

Trials

1

Recruited

350+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+