Is Prophylactic Parenteral Paracetamol Effective to Diminish Incidence of PDA in Preterm Neonates? A Randomized Trial

Background: Patent ductus arteriosus (PDA) is a common cause of morbidity and mortality among preterm infants. This study aimed to assess the efficacy of prophylactic parenteral paracetamol dosage to decrease rate of ductus patency in preterm infants. Methods: The study was a randomized double-masked clinical trial that was conducted at Afzalipour tertiary medical center (Kerman, Iran) between Novembers 2015 and 2016, recruiting 160 neonates with gestational age less than 34 weeks who were equally divided into case and control arms. The neonates of case group received parenteral paracetamol with the loading dose of 20 mg/kg and maintenance dose of 7.5 mg/kg every 6 hours during first three postnatal days and the neonates of control group received nothing. Thereafter, echocardiography was done at the day 4 to detect any ductus patency. Results: Among the included infants and after intervention, 12 (15%) in case group and 57 (71.25%) in control group had PDA. Ductus patency incidence among the neonates of case group was significantly lower than in control group. Means of assisted ventilation requirement, cardiac shortening fraction and mortality rate were not significantly different comparing the two groups. Conclusions: This study showed that the prophylactic dosage of parenteral paracetamol can prevent ductus patency and accounts as a trustworthy alternative to the traditional drugs e.g. Ibuprofen or Indomethacin.