Background: Hemodynamically significant patent ductus arteriosus (hs-PDA) is a common cause of morbidity and mortality among preterm infants, affecting more than 40% of preterm infants. A persistent hs-PDA can cause significant problems, especially in premature infants. Thus, the early closure of hs-PDA is important to prevent several comorbidities such as necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), pulmonary edema/hemorrhage, and development of chronic lung disease (CLD).
Aim of the study: This study aimed at comparing the efficacy and safety of intravenous (IV) paracetamol compared with IV indomethacin for the pharmacological closure of PDA in preterm infants.
Study design: This prospective, randomized study enrolled 100 preterm infants admitted at Bab-elsheria neonatal intensive care unit between August 2020 and August 2022. with gestational age ≤ 35 weeks and postnatal age within first two weeks of life who had hemodynamically significant PDA confirmed by 2 D transthoracic echocardiography. They were randomized into 2 groups, group I (paracetamol group) 50 preterm neonates received 15 mg/kg/6 h IV paracetamol infusion for 3 days, and group II (indomethacin group) 50 preterm neonates received 0.2 mg/kg/12 h indomethacin IV infusion for three doses.
Results: The ductus was closed in 38 (76%) infants of the paracetamol group compared with 40 (80%) of the indomethacin group. The reopening rate was higher in the paracetamol group than in the indomethacin group, but the reopening rates were not statistically different (21% [8 of 38] vs 15% [6 of 40]; P =0 .695). The cumulative closure rates after the second course of drugs were high in both groups. Only 2 patient (4%) in the paracetamol group and also 2 patients (4%) in the indomethacin group required surgical ligation.
Conclusion: Our study showed that use of IV paracetamol is effective as IV indomethacin in medical closure of hs-PDA in premature infants, and has no side effects mainly on renal function, platelet count, and gastrointestinal bleeding.