Trial Comparing Shorter Versus Longer Trophic Feeding in Very Preterm Infants Born Between 25 and 31 Weeks to Reduce Late Onset Sepsis and Improve Outcomes

What this Trial Is About

Researchers are evaluating the best timing to advance enteral feeding in very preterm infants born between 25 and 31 weeks gestation who weigh less than 1500 grams at birth. The study aims to find out if starting to increase milk feeds earlier, after one day of small trophic feeds, compared to after three days of trophic feeds, reduces the risk of late-onset sepsis a serious infection occurring after the first 3 days of life without causing more complications. This multi-center, randomized controlled trial compares these two feeding strategies to improve survival and health outcomes in these vulnerable newborns. Infants will be randomly assigned to one of two feeding plans limited trophic feeds for about 24 hours or extended trophic feeds for about 72 hours, both at volumes of 20-25 mLkgday. After the assigned trophic feeding period, enteral feeds will be advanced by about 25-30 mLkgday until full feeding volumes of 140 mLkgday are reached, typically within two weeks. The feeds consist of the infants own mothers milk or donor human milk if the mothers milk is unavailable. The study allows adjustments if signs of feeding intolerance occur. Participants will be closely monitored throughout their hospital stay until around 40 weeks corrected gestational age. Researchers will assess the occurrence of culture-proven late-onset sepsis, length of hospital stay, death, use of intravenous nutrition and central lines, and other complications like necrotizing enterocolitis, brain hemorrhages, lung disease, and eye problems. Growth measurements such as weight, length, and head size changes will also be tracked. This thorough monitoring aims to determine the safest and most effective feeding approach for very preterm infants.

Limited Versus Extended Trophic Feeding (LET-FEED) Trial