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Table 1 Eligibility criteria

From: The NICU Antibiotics and Outcomes (NANO) trial: a randomized multicenter clinical trial assessing empiric antibiotics and clinical outcomes in newborn preterm infants

Infant inclusion criteria Newborn infants born with gestational age 23–28 6/7 weeks
Infants delivered at participating study sites
Infant exclusion criteria Infants at low risk for early-onset-sepsis: infants born for maternal indications via caesarean section with rupture of membranes within 6 h of delivery, no attempts to induce labor, or no concern for maternal infection
Infants at high risk for early-onset-sepsis: infants born to mothers with intrapartum fever >38 °C or infants with clinical diagnosis of chorioamnionitis (suspected or definite)
Infants with respiratory insufficiency requiring invasive mechanical ventilation and FiO2 > 0.40 or non-invasive ventilation (i.e., CPAP) with FiO2 > 0.60 at time of randomization
Infants with ongoing hemodynamic instability requiring vasopressors or more than one 10 ml/kg NS bolus at time of randomization
Clinician concern for sepsis due to physical exam findings (i.e., minimal responsiveness, poor tone)
Major congenital abnormalities (i.e., cardiac, pulmonary, gastrointestinal anomalies)
Infants not anticipated to survive beyond 72 h
Infants who have received antibiotics prior to randomization
Maternal exclusion criteria Mothers that are <18 years old at time of consent
  1. FiO2 fraction of inspired oxygen, CPAP continuous positive airway pressure