NICU Antibiotics and Outcomes Trial (NANO)
Microbial Colonization, Extreme Prematurity, Early-Onset Neonatal Sepsis
About this trial
This is an interventional treatment trial for Microbial Colonization focused on measuring premature birth, human microbiome, antibiotics
Eligibility Criteria
I. Inclusion criteria: We will enroll newborn infants with gestational age of 23-28 weeks born to mothers 18 years or older at participating study sites. Only inborn infants at participating study sites will be eligible.
II. Exclusion criteria:
- Infants born for maternal indications via caesarean section with rupture of membranes at delivery, without attempts to induce labor, and without concern for maternal infection
Infants at high risk of EOS
- Infants born to mothers with intrapartum fever (> 38C) or clinical diagnosis of chorioamnionitis
- Infants born to mothers with proven GBS colonization or indication for intrapartum antibiotic prophylaxis that did not receive adequate antibiotic treatment according to specialty specific guidelines (i.e. penicillin, ampicillin, and cefazolin)
- Infants born to mothers with previous infant with GBS disease/infection
- Infants with respiratory insufficiency requiring invasive mechanical ventilation and FiO2 > 0.40 or non-invasive ventilation and FiO2 > 0.60 at time of randomization
- Infants with ongoing hemodynamic instability requiring vasopressors or fluid boluses at time of randomization
- Clinician concern infant is at high risk for sepsis due to infant physical exam findings or clinical history of mother or infant
- Major congenital anomalies
- Infants not anticipated to survive beyond 72 hours
- Infants who have received antibiotics prior to randomization
- Mothers that are <18 years old at time of enrollment
Sites / Locations
- Sharp Mary Birch Hospital for Women & NewbornsRecruiting
- Yale University School of MedicineRecruiting
- University of South Flordia HealthRecruiting
- University of Kansas Medical Center
- University of Louisville Research Foundation Inc./Kosair Charities Pediatric Clinical Research UnitRecruiting
- Children's Mercy
- SUNY Downstate Medical CenterRecruiting
- The Trustees of Columbia University in the City of New YorkRecruiting
- Golisano Children's Hospital at University of Rochester
- Maria Fareri Children's Hospital at Westchester Medical CenterRecruiting
- Penn State Medical CollegeRecruiting
- Pennsylvania Hospital/The Children's Hospital of PhiladelphiaRecruiting
- Alfred I. duPont for Children of the Nemours FoundationRecruiting
- Magee Womens HospitalRecruiting
- University of Texas Health Science Center at San AntonioRecruiting
- Mount Sinai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Empiric antibiotics
Placebo
Infants will receive standard antibiotic coverage of ampicillin and gentamycin at site approved dosing guidelines while completing an evaluation for early-onset neonatal sepsis.
Infants will receive a volume matched placebo of normal saline while completing an evaluation for early-onset neonatal sepsis.