NICU Antibiotics and Outcomes Trial
Completed · Phase 4 · Has a placebo group
Conditions studied: Microbial Colonization, Extreme Prematurity, Early-Onset Neonatal Sepsis, Late-Onset Neonatal Sepsis, Necrotizing Enterocolitis of Newborn, Death; Neonatal
In brief
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.
Key facts
- Study ID
- NCT03997266
- Run by
- Michael Morowitz
- People needed
- 359
- Starts
- 2020-08-05
- Expected to finish
- 2026-01-15
- Last updated by the study team
- 2026-04-24
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
Where it is running
- USA Children's and Women's Hospital — Mobile, Alabama, United States
- Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- University of South Flordia Health — Tampa, Florida, United States
- University of Louisville Research Foundation Inc./Kosair Charities Pediatric Clinical Research Unit — Louisville, Kentucky, United States
- The Trustees of Columbia University in the City of New York — New York, New York, United States
- Golisano Children's Hospital at University of Rochester — Rochester, New York, United States
- Maria Fareri Children's Hospital at Westchester Medical Center — Valhalla, New York, United States
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States
- Penn State Medical College — Hershey, Pennsylvania, United States
- Pennsylvania Hospital/The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Alfred I. duPont for Children of the Nemours Foundation — Philadelphia, Pennsylvania, United States
- Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.