Comparison of Therapeutic Effects and Side Effects of Oral Ibuprofen and Indomethacin on the Closure of Patent Ductus Arteriosus in Premature Infants

BACKGROUND AND OBJECTIVE: Patent ductus arteriosus (PDA) is a common problem in premature infants. Indomethacin is the first effective drug used to treat this problem and due to the side effects of this drug, intravenous ibuprofen is one of the recommended drugs in this field. Due to the unavailability of intravenous form of these drugs in Iran, this study was conducted to compare therapeutic effects and side effects of the oral form of ibuprofen and indomethacin on the closure of PDA in premature infants. METHODS: In this randomized clinical trial, 80 premature infants (less than 32 weeks) with symptomatic PDA, who required treatment were randomly divided into two groups of 40 and were treated with indomethacin or oral ibuprofen. Results (changes in PDA size and percentage of recovery) and complications (changes in creatinine and serum bilirubin, intraventricular hemorrhage, necrotizing enterocolitis and death) of treatment were recorded and compared between the two groups. (IRCT: 2015111024977N1) FINDINGS: There was no significant difference between the two groups in terms of confounding variables. The treatments had to be repeated for ten percent of patients (four patients) in both groups. PDA size did not change in ten percent of patients (four patients) in indomethacin group and did not change in seven point five percent of patients (three patients) in ibuprofen group. The two groups did not differ significantly in terms of probable side effects. None of the patients in the two groups needed surgery. CONCLUSION: Considering that in this study, the response rate and side effects of oral ibuprofen and indomethacin did not differ significantly, this drug could be an appropriate alternative for indomethacin when necessary.