NICU Antibiotics and Outcomes Trial

Who is this study for? Infant patients with Extremely Low Birthweight
Status: Active_not_recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: Newborn
Healthy Volunteers: f
View:
Locations
United States
Alabama
USA Children's and Women's Hospital
Mobile
California
Sharp Mary Birch Hospital for Women & Newborns
San Diego
Connecticut
Yale University School of Medicine
New Haven
Florida
University of South Flordia Health
Tampa
Kentucky
University of Louisville Research Foundation Inc./Kosair Charities Pediatric Clinical Research Unit
Louisville
North Carolina
Atrium Health Wake Forest Baptist
Winston-salem
New York
The Trustees of Columbia University in the City of New York
New York
Golisano Children's Hospital at University of Rochester
Rochester
Maria Fareri Children's Hospital at Westchester Medical Center
Valhalla
Pennsylvania
Penn State Medical College
Hershey
Alfred I. duPont for Children of the Nemours Foundation
Philadelphia
Pennsylvania Hospital/The Children's Hospital of Philadelphia
Philadelphia
Magee Womens Hospital
Pittsburgh
Texas
University of Texas Health Science Center at San Antonio
San Antonio
Time Frame
Start Date: 2020-08-05
Completion Date: 2027-06-01
Participants
Target number of participants: 802
Treatments
Active_comparator: Empiric antibiotics
Infants will receive standard antibiotic coverage of ampicillin and gentamycin at site approved dosing guidelines while completing an evaluation for early-onset neonatal sepsis.
Placebo_comparator: Placebo
Infants will receive a volume matched placebo of normal saline while completing an evaluation for early-onset neonatal sepsis.
Sponsors
Leads: Michael Morowitz
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov