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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