Prophylactic teatment with oral paracetamol for patent ductus arteriosus in preterm infants: a randomized clinical trial

The incidence of Patent Ductus Arteriosus (PDA) in premature infants whose birth weight is less than 1500 grams is approximately 30-60%, most of them need medical or surgical interventions. The purpose of this study is to determine the efficacy of prophylactic treatment with oral paracetamol (Acetaminophen- Hakim® Oral Drops 100 mg/ml, Hakim Pharmaceutical Co., Tehran, Iran) for PDA in preterm infants. A randomized clinical trial conducted from March 2012 to March 2013. Thirty-two preterm newborns whose gestational age was under 32 weeks and birth weight was 1500 grams or less, admitted in neonatal intensive care unit (NICU) of Vali-Asr Hospital, Tehran were studied prospectively. They were randomly assigned in two groups. The prophylaxis group received oral paracetamol for a period of two days starting during first 24 hours of life. No placebo was given to the control group. Echocardiography was performed 24-36 hours after the last given dose in prophylaxis group and on the 4th and 5th day in control group. A p-value less than 0.05 are considered significant. There were 16 newborns in each group (20 boys and 12 girls). In 12 newborns of prophylaxis group the ductus arteriosus was closed although in control group in 8 newborns the duct was closed. No significant difference was observed in sex, gestational age, birth weight, mode of delivery, multifetal gestation and birth order between two groups. The rate of ductal closure was 75% and 50% in prophylaxis group and control group respectively (P=0.27). Our study demonstrated that prophylactic paracetamol is ineffective in PDA closure, although the rate of ductal closure between two groups seems remarkable. Paracetamol as a new strategy for PDA closure because of cost effectiveness and harmlessness may be used in future. However, we presume larger sample size studies are needed to show the efficacy of paracetamol, side effects, and complications in PDA prophylaxis treatment.