Table 2.

Inclusion and exclusion criteria of the study.

Inclusion criteria	Exclusion criteria
Written informed consent of parents/guardians	Major congenital malformations or chromosomopathies
GA ≤ 30 weeks	Imminent death
Postnatal age ≤ 2 weeks	Impossible or erroneous randomization
Need for ventilatory support	Participation in another clinical trial with medication
Birth or arrival in participating hospital within the period of application of the treatment	Diuresis <1 mL/kg/h in the 8 h prior to treatment or creatinine >1.8 mg/dL
First episode of hsPDA	Platelets <50,000/μL or active hemorrhage (tracheal, digestive, or renal)
	Recent (past 48 h) IVH (grades 3–4)
	Septic shock
	Severe hyperbilirubinemia or severe coagulopathy or liver failure
	Active NEC or intestinal perforation