Condition: Sepsis · Length of Stay · Mortality · Sponsor: University of Washington
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 con…
This description comes directly from the study's public registry record.
Gregory C Valentine, MD MED FAAP · (206) 543-3200 · gcvalent@uw.edu
Ariel Salas, MD, MSPH · asalas@uabmc.edu
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| University of Alabama at Birmingham | Birmingham, Alabama, United States | Not Yet Recruiting |
| University of South Florida | Tampa, Florida, United States | Not Yet Recruiting |
| University of Oklahoma | Oklahoma City, Oklahoma, United States | Not Yet Recruiting |
| Baylor College of Medicine | Houston, Texas, United States | Not Yet Recruiting |
| University of Washington | Seattle, Washington, United States | Not Yet Recruiting |
| St. Joseph's Medical Center | Tacoma, Washington, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06893939