Therapeutic Effect and Safety of Early Treatment of Patent Ductus Arteriosus with Oral Ibuprofen in Preterm Infants

Abstract

Background: Patent ductus arteriosus (PDA) is a common problem encountered in premature infants, especially those with respiratory distress syndrome. PDA can lead to life-threatening complications. Intravenous ibuprofen was shown to be as effective and to cause fewer side effects. If ibuprofen is effective intravenously, it will probably be effective orally too. Aim: This study was designed to determine the effectiveness and safety of oral ibuprofen compared to IV ibuprofen or no intervention for closing a PDA in preterm infants with RDS. Material and methods: A prospective study, randomized, a blindfold was conducted in NICU, at UOGH "Koço Gliozheni", Tirana, from February 2010-August 2013. The study included a total of 128 preterm infants, 28-35 weeks, ≤2500gr birth weight, in the first 48-96 hours of life, with SDR and confirm the presence of DBA's (Ǿ≥1.5mm) by echocardiographic examination. Infants were treated with Ibuprofen oral, intravenous Ibuprofen, no medical interventions, in randomized order. The cycle of treatment: 10 + 5 + 5/mg/kg, every 24 hours. Were highlighted the basic characteristics of infants included in the study, the effectiveness of treatment (closure of DBA's), side effects, complications, and the effectiveness of treatment. For continuous variables were calculated the average and standard deviation. The p≤0.05 value was accepted as statistically significant. All tests are two-sided. RR and OR were presented with 95% CI. Results: 38 infants were treated with Ibuprofen oral, 35 infants with intravenous Ibuprofen and 37 infants underwent no medical intervention. The effectiveness of early treatment: DBA remained open, after early treatment, in 7foshnja (18.4%) in group oral Ibuprofen vs 20 infants (54%) in the group that did not undergo any medical intervention [RR = 0.34; 95% CI = 0.16-0.7; p = 0.04], vs 6 infants (17.1%) in the group of intravenous Ibuprofen [RR = 1.07; 95% CI = 0.4-2.8; p≥0.05]. There was observed no statistically significant change of direction of side effects and complications, p≥0.05. Conclusions: Oral Ibuprofen is an effective and safe alternative when used for the treatment of DBAs to babies born prematurely and with low birth weight.

Keywords: DBA, preterm births, Ibuprofen, treatment of early/late, side effects, complication.