Trophic Feeding for Sepsis Prevention
(LET-FEED Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications. It focuses on feeding regimens for preterm infants, so it's best to consult with the trial coordinators for specific guidance.
What data supports the effectiveness of the treatment Extended Trophic Feeds, Limited Trophic Feeds for sepsis prevention?
Some studies suggest that starting nutritional support early in critically ill patients, like those with sepsis, may help reduce infections such as pneumonia. Additionally, certain nutrients in these feeds, like arginine and glutamine, have been shown to decrease infections in surgical patients, which might be beneficial for sepsis prevention.12345
Is trophic feeding generally safe for humans?
Trophic feeding, which involves providing small amounts of nutrition, is generally considered safe for critically ill patients, including those with sepsis. It is often recommended to use the enteral route (feeding through the gut) whenever possible, as it is assumed to be beneficial and safe based on studies in other critically ill patients.36789
How does the treatment of trophic feeding for sepsis prevention differ from other treatments?
Trophic feeding for sepsis prevention is unique because it involves providing small amounts of nutrition to stimulate the gut without overwhelming it, which may help maintain gut integrity and prevent infections. This approach is different from standard treatments that often focus on antibiotics and supportive care, as it aims to prevent sepsis by supporting the body's natural defenses through nutrition.1011121314
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants receive either limited trophic feeds for 24-36 hours or extended trophic feeds for 72-84 hours before advancing to full enteral feeds
Follow-up
Participants are monitored for safety and effectiveness after treatment, including monitoring for late-onset sepsis and other secondary outcomes
Long-term Follow-up
Monitoring of growth metrics and other health outcomes until 36 weeks corrected gestational age
Treatment Details
Interventions
- Extended Trophic Feeds
- Limited Trophic Feeds
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
University of Oklahoma
Collaborator
Baylor College of Medicine
Collaborator
University of South Florida
Collaborator
St. Joseph's Medical Center
Collaborator
University of Alabama at Birmingham
Collaborator