Limited Versus Extended Trophic Feeding (LET-FEED) Trial
Launched by UNIVERSITY OF WASHINGTON · Mar 18, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The LET-FEED Trial is a research study designed to see if starting feeding earlier (after 24 hours of birth) for very preterm infants can help reduce the risk of infections (specifically late-onset sepsis) compared to starting feeding later (after 72 hours). This study will involve infants born between 25 to 31 weeks of gestation who weigh less than 1500 grams. To be part of the trial, parents must provide consent within the first day and a half after their baby is born.
During the study, eligible infants will be randomly assigned to receive either limited feeding for one day or extended feeding for three days before moving on to regular feeding amounts. The babies will primarily receive their own mother's milk, or donor milk if necessary. Researchers will keep track of how these feeding schedules affect infection rates, hospital stays, and other health outcomes. This trial aims to find the safest way to feed very premature infants while ensuring their health and growth during their hospital stay.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • \<1500 gram birthweight
- • 25w0d-31w6d at birth
- • Consent to feed donor milk when parent's own milk is not available or of insufficient quantity
- Exclusion Criteria:
- • \<5th percentile for weight at birth (Fenton growth curve)
- • Parent or legal guardian unable to provide consent within 36 hours after birth
- • Congenital anomaly affecting decisions on enteral feedings (e.g. gastroschisis, omphalocele, congenital diaphragmatic hernia, congenital heart disease, etc.)
- • Known genetic condition affecting growth, feeding, or mortality
- • Vasopressor use within first 24 hours after birth (not including hydrocortisone)
- • Considered terminally ill
About University Of Washington
The University of Washington (UW) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust network of interdisciplinary teams, UW fosters collaboration among top-tier researchers, clinicians, and healthcare professionals, aiming to translate scientific discoveries into impactful treatments and interventions. The university is dedicated to ethical research practices and participant safety, ensuring rigorous adherence to regulatory standards in all clinical trials. Through its state-of-the-art facilities and extensive expertise, UW strives to address pressing health challenges and improve patient outcomes on a local and global scale.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Seattle, Washington, United States
Birmingham, Alabama, United States
Oklahoma City, Oklahoma, United States
Tampa, Florida, United States
Tacoma, Washington, United States
Patients applied
Trial Officials
Gregory C Valentine
Principal Investigator
University of Washington
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported