Background: Patent ductus arteriosus (PDA) is a common finding among premature or low-birth-weight infants and it often does not close. Nowadays, drugs used for its treatment include indomethacin and more commonly ibuprofen. Oral ibuprofen was recently shown to be as effective and have several important advantages in preterm infants. Studies performed to find the best dose of ibuprofen for PDA treatment are limited; hence, we compared the effects of two different doses of ibuprofen in this interventional study.
Methods: In this randomized controlled clinical trial, we randomly divided 60 patients with echocardiographically confirmed PDA into two groups of 30. This study was done in NICU of Valiasr hospital in 1387-89 years. In the first group, we administered a loading dose of 10 mg/kg ibuprofen on the first day, followed by two doses of 5 mg/kg in the next two days. In the second group, we administered a loading dose of 15 mg/kg ibuprofen on the first day followed by two doses of 7.5 mg/kg in next two days. Eventually, we compared PDA closure rates and complications of therapy between the two groups.
Results: Thirty (100%) patients in 15-mg/kg group and 23 (76.7%) patients in 10 mg/kg group had successful PDA closure with no need for surgery. The two groups had a statistically significant difference (P=0.011) and the highest response to treatment was seen within the first 24 hours of treatment.
Conclusion: We may conclude that higher doses of ibuprofen (15 and 2×7.5 mg/kg) would offer better outcomes for PDA closure without gastrointestinal or renal complications and less need for surgery.