Ductus Arteriosus Closure With Paracetamol: a Pilot Study.

Patent ductus arteriosus is frequent in premature babies. With an incidence of 1:2500-5000, it accounts for 9% to 12% of congenital heart disease. Several different drugs have been tried for closure of hemodynamically significant patent ductus arteriosus. The first to be used was indomethacin, with a success rate of 70% and a reopening rate of 35%; however, the high cost of this drug has driven the search for other options such as ibuprofen. But such drugs are not harmless and are associated with decreased renal, mesenterial, and cerebral perfusion, and ibuprofen is associated with hyperbilirrubinemia. Recently, paracetamol has been demonstrated to be effective in this indication, with no reports of toxicity to date. In this study, we report the use of oral paracetamol in premature babies. The drug was safe and effective at closing the hemodynamically significant patent ductus arteriosus. Premature patients in their first 10 days of life with a gestational age of 30 to 36 weeks and hemodynamically significant patent ductus arteriosus were included in this study. The defect was considered hemodynamically significant when the Qp/Qs ratio was greater than 1.5/1 and the left atrium/aortic root ratio was greater than 1.8 in echocardiography and the patient needed ventilatory support. Patients with heart disease resulting from the defect, intraventricular hemorrhage, thrombocytopenia, renal failure, hyperbilirubinemia, and necrotizing enterocolitis were excluded. Patients were divided into 2 groups according to weight: group 1 weighing less than 1 kg and group 2 weighing more than 1 kg. Both groups were treated with oral paracetamol at 15 mg/kg/dose every 6 hours (total cumulative dose 60 mg/kg). Echocardiographic follow-up was done at 48 hours after the first dose. A second cycle of the drug was administered if the ductus arteriosus had not closed. If the ductus arteriosus still had not closed after this second cycle, the patient was referred for surgical closure. All patients received fluid therapy on the first day at 70 mL/kg/d, with a daily increase of 10 to 20 mL/kg/d up to a maximum of 160 mL/kg/d at the end of the first week of life.