Efficacy of paracetamol in the management of hemodynamically significant patent ductus arteriosus in preterm newborns.

Objective: The objective is to determine the efficacy and safety of paracetamol in preterm babies with hemodynamically significant patent ductus arteriosus (hsPDA).

Background: In preterm babies, patent ductus arteriosus, when hemodynamically significant, causes considerable morbidity and mortality and also affects 20% of very low birth weight infants. Medical therapy is the mainstay of treatment. Currently used drug cyclooxygenase inhibitor has multiple serious adverse effects, including gastrointestinal perforation, bleeding, and renal failure. Hence, an alternative drug like paracetamol has been proposed for the treatment of hsPDA for fewer side effects. Hence, we used paracetamol in our neonatal intensive care unit in preterm neonates with hsPDA.

Methods: A total of 14 preterm babies diagnosed to have hsPDA on clinical and echocardiographic evaluation in neonatal ICU on days 3-14 of life during 13 months were included. Birth weight was between 1000 g and 1650 g and gestation was between 28 weeks and 33 weeks. Paracetamol in a dose of 15 mg/kg/dose every six hourly given to all the included babies for 3 days and re-evaluated echocardiographically after 3 days of treatment.

Results: In 12 (86%) out of 14 cases, PDA was closed, whereas in 2 (14%) hemodynamic closure with insignificant residual flow was achieved. Paracetamol was effective in 100% of cases. No adverse event was observed during treatment.

Conclusions: Paracetamol is a very safe and efficacious drug for treating hemodynamically significant patent ductus arteriosus in premature babies.