Prophylactic medical treatment of patent ductus arteriosus with ibuprofen is not indicated

Introduction: Patent ductus arteriosus (PDA) is still one of the most common problems found in preterm infants. It often complicates the clinical course of preterms and increases the risk of intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), chronic lung disease (CLD) and death.

However, there continues to be controversy as to the appropriate indications and means for treatment varying from prophylaxis to treatment only when a PDA is demonstrably significant.

Aim of the study: To determine that prophylactic use of Ibuprofen in closure of PDA is not indicated because of a high closure rate after conservative treatment by means of adapting ventilation and fluid restriction.

Methods: We performed a retrospective study from January 1st 1999 till December 31st 2004. 109 newborns 30 weeks gestational age were ventilated and required surfactant replacement therapy. In this population the percentage of PDA was determined. None of the children received Ibuprofen or Indomethacin. A clinical significant PDA was treated either conservatively with fluid restriction and adapting ventilation or surgically by means of ductal ligation.

Results: In our population 78 newborns (=72%) did not have PDA. 31 neonates (=28%) developed a clinical significant PDA. These babies were treated conservatively by means of adapting ventilation and fluid restriction. None of them received Ibuprofen or Indomethacin. Ductus was closed in 25 neonates. Only 6 children (=6%) required ductal ligation. These results lead to a total closure rate of 94% without prophylactic treatment with Ibuprofen. As to the major complications of NEC, IVH, CLD and death, our results were compared to the Vermont Oxford network. No higher rate of these complications was observed.

Conclusion: 72% of our newborns did not develop PDA. That means that 72% would have been treated unnecessarily. Early treatment of clinical significant PDA with fluid restriction and adapting ventilation results up to a closure rate of 94%. No more major complications (NEC, IVH, CLD and death) were observed. According to literature closure rate after Ibuprofen treatment is 90%. That means that closure of PDA without prophylactic Ibuprofen treatment is as effective as prophylactic Ibuprofen treatment without more major complications and without potential side-effects of Ibuprofen. Therefore we postulate that prophylactic medical treatment of PDA with Ibuprofen is not indicated.