Sanket D Shah1, Kartikeya Makker2, Mingyu Zhang3, Susan Harnett4, Khyzer B Aziz2, Mark L Hudak5. 1. Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine, Jacksonville, FL, USA. sdshah_5@yahoo.com. 2. Division of Neonatology, Department of Pediatrics, Johns Hopkins Children's Center, Johns Hopkins University, Baltimore, MD, USA. 3. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. 4. Nemours Children's Health, Jacksonville, FL, USA. 5. Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine, Jacksonville, FL, USA.
Abstract
OBJECTIVE: To examine the efficacy of dual medication therapy (intervention) (DMT: acetaminophen and ibuprofen) vs. single medication therapy (control) (SMT: ibuprofen) for medical management of PDA (outcomes) in preterm infants (population). STUDY DESIGN: We systematically searched multiple sources to identify randomized controlled trials (RCT) and non-randomized studies (NRS) that compared DMT to SMT for management of hemodynamically significant PDA. RESULTS: We identified two RCTs and four NRS. There were no differences in the rates of successful PDA closure following the first treatment course between DMT and SMT (RR = 1.23 [95% CI 0.89-1.70] for NRS and RR = 1.18 [95% CI 0.66-2.10] for RCTs), nor were there significant differences in secondary outcomes and adverse events including PDA ligation, bronchopulmonary dysplasia, and necrotizing enterocolitis etc. Markers of hepatic/renal function did not change significantly during treatment. CONCLUSION: We found no evidence for superiority of DMT over SMT in PDA management.
OBJECTIVE: To examine the efficacy of dual medication therapy (intervention) (DMT: acetaminophen and ibuprofen) vs. single medication therapy (control) (SMT: ibuprofen) for medical management of PDA (outcomes) in preterm infants (population). STUDY DESIGN: We systematically searched multiple sources to identify randomized controlled trials (RCT) and non-randomized studies (NRS) that compared DMT to SMT for management of hemodynamically significant PDA. RESULTS: We identified two RCTs and four NRS. There were no differences in the rates of successful PDA closure following the first treatment course between DMT and SMT (RR = 1.23 [95% CI 0.89-1.70] for NRS and RR = 1.18 [95% CI 0.66-2.10] for RCTs), nor were there significant differences in secondary outcomes and adverse events including PDA ligation, bronchopulmonary dysplasia, and necrotizing enterocolitis etc. Markers of hepatic/renal function did not change significantly during treatment. CONCLUSION: We found no evidence for superiority of DMT over SMT in PDA management.