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NCT06893939
Limited Versus Extended Trophic Feeding (LET-FEED) Trial
Conditions: Sepsis, Length of Stay, Mortality, Neurodevelopmental Delay
Sex: All
Ages: 0 Hours – 2 Years
Healthy volunteers: Yes
Phase: PHASE2, PHASE3
Enrollment: 350
Sponsor: University of Washington
Location: University of Alabama at Birmingham Birmingham Alabama
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 \
Eligibility Criteria
Inclusion Criteria:
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Source: ClinicalTrials.gov (NCT06893939). StuddyBuddy aggregates publicly available trial information.