The Effect of Oral Ibuprofen on the Closure of Patent Ductus Arteriosus in Term Neonates: A Clinical Trial Study

Authors

1 Assistant Professor, Department of Pediatrics, Shahrekord University of Medical Sciences, Shahrekord, Iran

2 Associate Professor, Department of Pediatrics, Shahrekord University of Medical Sciences, Shahrekord, Iran.

3 Assistant Professor, Department of Biostatistics, Shahrekord University of Medical Sciences, Shahrekord, Iran.

4 Medical Student, Shahrekord University of Medical Sciences, Shahrekord, Iran.

10.22038/ijp.2020.46088.3758

Abstract

Background: The ductus arteriosus is functionally closed within a few minutes to a few days after birth in term neonates. Sometimes the duct remains open after birth, which is called patent ductus arteriosus (PDA). PDA is associated with high rate of neonatal mortality and morbidity. The present study aimed to evaluate the effect of oral ibuprofen on closure of PDA in term neonates.
Methods: In this clinical trial, 40 neonates (gestational age of 37 weeks and more) aged 5-30 days with echocardiographically confirmed PDA were randomly divided into two groups (n= 20). One group received ibuprofen syrup (10 mg/kg body weight) in first 24 hours followed by 5 mg/kg body weight for the following four consecutive days. Another group received placebo per the same scheme. On the seventh day after beginning of the intervention, neonates underwent echocardiography for examination of PDA closure. Side effects of ibuprofen were evaluated. Symptoms of kidney failure, such as oliguria, edema, and proteinuria, and increased creatinine, as well as gastrointestinal side effects such as gastrointestinal bleeding and recurrent vomiting, were assessed for one month.
Results: According to the results PDA diameter was not significantly different between ibuprofen and placebo groups before (p>0.05) and after (p>0.05) intervention. Frequency of PDA closure was 13 (65%) in the ibuprofen group and 10 (50%) in the placebo group with no significant difference (p>0.05). There was no significant difference in the mean systolic and diastolic pressure gradient after intervention and in mean changes in pulmonary arterial hypertension between two groups (p>0.05). No side effects were observed in groups.
Conclusion: Oral ibuprofen did not significantly affect PDA closure in term neonates.

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