Journal
PEDIATRIC DRUGS
Volume 22, Issue 6, Pages 685-693Publisher
ADIS INT LTD
DOI: 10.1007/s40272-020-00412-4
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- Department of Pediatrics, Faculty of Medicine, Alexandria University, Egypt
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Background The management of severe persistent pulmonary hypertension (PPHN) can be very challenging in many resource-limited centers without access to inhaled nitric oxide or extracorporeal membrane oxygenation. Objectives The current study aimed to investigate the efficacy of oral sildenafil and intravenous milrinone infusion and compare the effects of these drugs in combination versus as monotherapy in neonates with PPHN. Methods A double-blind randomized controlled trial was conducted in which neonates with PPHN were divided into three groups of 20 patients each: group 1 received oral sildenafil starting at 0.5 mg/kg every 6 h to a target maintenance dose of 2 mg/kg every 6 h; group 2 received intravenous milrinone 0.5 mu g/kg/min as a continuous infusion; and group 3 received both oral sildenafil and intravenous milrinone. Results Post-treatment pulmonary artery systolic pressure was significantly lower in group 3 than in groups 1 and 2, which both received monotherapy (p = 0.031). The oxygenation index also decreased significantly in the dual-therapy group (p = 0.002) compared with the monotherapy groups. Combined use of both drugs demonstrated a beneficial synergistic effect with better outcomes and reduced mortality. Conclusion Dual therapy using sildenafil and milrinone was superior to monotherapy with either drug in neonates with severe PPHN and is recommended for use in resource-constrained settings. Registration Pan African Clinical Trial Registry identifier number PACTR201902691230243.
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