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Table 4 Events of Special Interest

From: Safety of sildenafil in premature infants with severe bronchopulmonary dysplasia (SILDI-SAFE): a multicenter, randomized, placebo-controlled, sequential dose-escalating, double-masked, safety study

Event Definition
Sepsis Positive blood culture with an organism not typically considered a contaminant
Urinary tract infection Positive urine culture with an organism not typically considered a contaminant
Bacterial meningitis Positive cerebrospinal fluid culture with an organism not typically considered a contaminant
Retinopathy of Prematurity (ROP) ROP requiring treatment with laser photocoagulation or an anti-VEGF drug
Seizures Determined by the treating provider
Abnormal hearing test results Based on testing during primary hospitalization
Systemic arterial or deep venous thrombosis Thrombosis requiring treatment with anticoagulation (e.g., heparin or low-molecular-weight heparin)
Direct hyperbilirubinemia Conjugated serum bilirubin > 2.0 mg/dL
Elevated transaminases ALT > 150 U/L or AST > 225 U/L
Endotracheal intubation Intubation and transition from non-invasive to invasive ventilation, not due to planned surgical procedure (e.g., inguinal hernia repair or ROP treatment)
  1. Abbreviations: ROP retinopathy of prematurity, VEGF vascular endothelial growth factor, ALT alanine aminotransferase, AST aspartate aminotransferase