Abstract
Objective. To compare the patent ductus arteriosus (PDA) closure rate of combined treatment with intravenous ibuprufen+paracetamol vs. ibuprufen+placebo, in very low birthweight (VLBW) preterm infants with hemodinamically significant PDA (hsPDA).
Background. hsPDA remains a common problem among VLBW neonates. Ibuprofen or paracetamol are both acceptable treatments, with limited success rate. This is the first study to assess the combination of both drugs in the treatment of PDA, compared to ibuprofen alone.
Methods. Single center, double blind, randomized controlled pilot study. Infants were randomly assigned for treatment with 1-2 courses of either intravenous ibuprofen (3 doses per course) + paracetamol (12 doses per course) (n=12) or ibuprufen+placebo (n=12).
Results. Baseline characteristics were comparable in the paracetamol and the placebo groups (Median [range] birth weight 1110 [875-1375] g vs. 945 [675-1150] g, 27.6 [25.6-30.0] weeks vs. 27.2 [25.5-29.2] weeks` gestation, day of 1st treatment: 6.5 [4-10] vs. 6 [5-8], respectively). Echocardiography parameters were comparable before the 1st treatment course in both groups. Overall hsPDA closure rate was significantly higher in the paracetamol group in comparison to the placebo group (83% versus 42%, p=0.049). PDA closure rate in the paracetamol and the placebo group after the 1st course was 60% vs. 25% (p=0.4) and after the 2nd course 66% vs. 22% (p=0.36), respectively. No adverse effects, clinical or laboratory, were associated with adding paracetamol.
Conclusion. In our pilot study, adding intravenous paracetamol to ibuprofen treatment for hsPDA in VLBW infants increased significantly the PDA closure rate. Adverse outcomes were not detected.
