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Table 3 Open label criteria

From: Early treatment versus expectative management of patent ductus arteriosus in preterm infants: a multicentre, randomised, non-inferiority trial in Europe (BeNeDuctus trial)

  I. Exclusion of other causes of cardiovascular failure (e.g. sepsis or congenital heart defect)
AND
  II. Clinical findings of cardiovascular failure secondary to significant ductal left-to-right shunting:
   a. Signs of systemic hypoperfusion (refractory systemic hypotension and/or elevated serum lactate concentration (> 2.5 mmol/L)) and;
   b. Signs of pulmonary hyperperfusion (prolonged ventilator dependency).
AND
  III. Echocardiographic findings of significant ductal left-to-right shunting
   a. Diameter of PDA > 1.5 mm, and;
   b. Unrestricted ductal left-to-right shunting (‘pulsatile pattern’): end-diastolic flow velocity < 50% of peak flow velocity, and;
   c. End-diastolic flow velocity left pulmonary artery > 0.3 m/s, and;
   d. Left atrial to aortic ratio > 1.5.
   AND
   a. Severe left ventricular failure (mitral regurgitation), and;
   b. Disturbed end-organ perfusion (retrograde diastolic blood flow in descending aorta).