The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested is that the incidence of adverse outcomes is higher in babies receiving empiric antibiotics (EA) in the first week of life compared to babies receiving placebo. The study targets a population of ELBW infants in whom the clinical decision to use or not use EA is currently most challenging -- infants that are clinically stable that did not have a known exposure to intraamniotic infection and were not born preterm for maternal indications. The primary outcome is the composite outcome of late-onset sepsis (LOS), necrotizing enterocolitis (NEC), or death during the index hospitalization. Secondary safety outcomes will include total antibiotic days, days to full enteral feedings, and common morbidities in preterm infants that have previously been linked to EA, e.g. retinopathy of prematurity and bronchopulmonary dysplasia. Weight and length z-score, and head circumference, are standard measures to be collected weekly by clinical team per a standardized protocol.
Microbial Colonization, Extreme Prematurity, Early-Onset Neonatal Sepsis, Late-Onset Neonatal Sepsis, Necrotizing Enterocolitis of Newborn, Death; Neonatal
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested is that the incidence of adverse outcomes is higher in babies receiving empiric antibiotics (EA) in the first week of life compared to babies receiving placebo. The study targets a population of ELBW infants in whom the clinical decision to use or not use EA is currently most challenging -- infants that are clinically stable that did not have a known exposure to intraamniotic infection and were not born preterm for maternal indications. The primary outcome is the composite outcome of late-onset sepsis (LOS), necrotizing enterocolitis (NEC), or death during the index hospitalization. Secondary safety outcomes will include total antibiotic days, days to full enteral feedings, and common morbidities in preterm infants that have previously been linked to EA, e.g. retinopathy of prematurity and bronchopulmonary dysplasia. Weight and length z-score, and head circumference, are standard measures to be collected weekly by clinical team per a standardized protocol.
NICU Antibiotics and Outcomes Trial
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USA Children's and Women's Hospital, Mobile, Alabama, United States, 36688
Sharp Mary Birch Hospital for Women & Newborns, San Diego, California, United States, 92123
Yale University School of Medicine, New Haven, Connecticut, United States, 06520-8064
University of South Flordia Health, Tampa, Florida, United States, 33606
University of Kansas Medical Center, Kansas City, Kansas, United States, 66160
University of Louisville Research Foundation Inc./Kosair Charities Pediatric Clinical Research Unit, Louisville, Kentucky, United States, 40202
Children's Mercy, Kansas City, Missouri, United States, 64108
SUNY Downstate Medical Center, Brooklyn, New York, United States, 11203
The Trustees of Columbia University in the City of New York, New York, New York, United States, 10032-3702
Golisano Children's Hospital at University of Rochester, Rochester, New York, United States, 14642
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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to 4 Hours
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No
Michael Morowitz,
2026-06-01