Key result
Oral ibuprofen achieves ~94% PDA closure vs placebo in premature newborns.
Why the study?
Oral ibuprofen may offer advantages over intravenous treatment for PDA closure in premature infants, but its efficacy and safety needed evaluation.
Does oral ibuprofen improve the rate of patent ductus arteriosus closure in premature infants compared to placebo?
RCT (n=66)
Does oral ibuprofen improve the rate of patent ductus arteriosus closure in premature infants compared to placebo?
Absolute Event Rate: 93.9% vs 30.3%
Oral ibuprofen is highly effective for the closure of patent ductus arteriosus in premature infants, offering a potential alternative to the intravenous route.
May support oral ibuprofen as PDA option in preterms; hypothesis-generating and requires randomized confirmation before practice change.
Background aim of the study: Patent ductus arteriosus (PDA), a common finding among premature infants, is conventionally treated by intravenous indomethacin.Intravenous ibuprofen was recently shown to be as effective and to have fewer adverse reactions in preterm infants.If equally effective, then oral ibuprofen for PDA closure would have several important advantages over the intravenous route.This study was designed to determine whether oral ibuprofen treatment is efficacious and safe in closure of a PDA in premature infants.Patients and methods: Thirty-three premature group I (study group) were treated with ibuprofen 10 mg/kg administered through a feeding tube.Thirty-three premature group II (control group) receive placebo the two imaging procedures were again performed 24 h after each ibuprofen dose.When the PDA was still hemodynamically significant, as demonstrated by echocardiography, and there was no evidence of deterioration in brain ultrasonography, a second dose of ibuprofen 5 mg/ kg (placebo for control) was administered.A third equivalent dose was given after another 24 h if necessary.Cranial ultrasound was repeated 1 week after the last ibuprofen dose and again before discharge from the ward.Hematochemical analysis was preformed daily in the unit during the first days of life.Results: In the study group the rate of PDA closure was 93.9% (31 of 33 cases) while in the control group the rate of PDA closure was 30.3% (10 of 33 cases) with significant difference in between.
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Ghanem et al. (2010) conducted an RCT in Patent ductus arteriosus (n=66). Oral ibuprofen vs. Placebo was evaluated on PDA closure. Oral ibuprofen significantly increased the rate of patent ductus arteriosus closure compared to placebo in premature newborns (93.9% vs 30.3%).
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