107 Comparison of Oral and Intravenous Ibuprofen Treatment of PDA in VLBW Infants: A Randomized Clinical Trial

Abstract

BACKGROUND: PDA is a common complication of prematurity that frequently requires surgical or medical treatment. The most widely employed medical therapy for closure of PDA is indomethacin followed by intravenous ibuprofen. Oral ibuprofen has recently been investigated as an effective and safe alternative for PDA closure. AIM: The aim of our study was to compare oral and intravenous administrations with regard to efficacy and safety for treatment of PDA in preterm infants. DESIGN/METHODS: We studied 12 infants (gestational age, 23 to 32 weeks) who had echocardiographycally confirmed PDA. The infants were randomly assigned to receive three oral doses of ibuprofen lysine or three intravenous doses of ibuprofen lysine, 10 mg/Kg followed by 5 mg/Kg after 24 and 48 h. Every child underwent cranial ultrasonography before and after each ibuprofen dose. The rate of ductal closure, the need for additional treatment, side effects and complications were recorded. RESULT: Six patients were assigned to oral and six to intravenous ibuprofen treatment. The two groups were well matched for birth weight, gestational age, antenatal steroids, surfactant treatment and respiratory status at the enrolment in the study. There were no significant differences in age of starting therapy. In both groups the rate of PDA closure was 100% and there was no reopening of the ductus 7 and 21 days after closure had been achieved. There were no significant differences in the levels of serum creatinine and urine output before and after treatment with oral or intravenous ibuprofen. We did not observe any significant bleeding tendency neither feeding intolerance in our patients. No significant differences between the groups were observed in with regard to frequency of BPD, IVH, NEC and ROP. CONCLUSIONS: Compared with intravenous ibuprofen treatment, oral ibuprofen is an effective and safe alternative for PDA closure in preterm infants.