The Effect of Oral Ibuprofen on 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.

Abstract

Background
The function of ductus arteriosus closes within a few minutes to a few days after birth in term neonates. In some cases, the duct remains open after birth, a condition which is called patent ductus arteriosus (PDA). PDA is associated with high rates of neonatal mortality and morbidity. The present study aims to evaluate the effect of oral ibuprofen on closure of PDA in term neonates.
Materials and Methods
In this clinical trial, 40 neonates (at the gestational age of 37 weeks and more) aged 5 to 30 days, with confirmed PDA through echocardiography, were randomly divided into two groups (n= 20). One group received ibuprofen syrup (10 mg/kg body weight) in the first 24 hours, followed by 5 mg/kg body weight for the next four days. The other group received placebo in the same manner. On the seventh day after the beginning of 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 in ibuprofen compared to the 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 the two groups (p>0.05). No side effects were observed in any of the groups.
Conclusion: Based on the results, oral ibuprofen did not significantly affect PDA closure in term neonates. 

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