Outcomes of Combination Treatment with Sildenafil and Mg Sulphate for Neonatal Pulmonary Hypertension Compared to Monotherapy with Sildenafil
Abstract
Background: Persistent pulmonary hypertension of the newborn (PPHN) as a serious neonatal condition is linked to impaired pulmonary vascular adaptation, hypoxemia, and considerable morbidity. Sildenafil is commonly used as a pulmonary vasodilator, while magnesium sulfate may provide an additional vasodilatory effect through a different mechanism This research aimed to compare the efficacy and safety of sildenafil combined with magnesium sulfate versus sildenafil alone in neonates with PPHN. Methods: This prospective randomized clinical trial included 48 neonates with echocardiographically confirmed pulmonary hypertension. Participants were assigned equally to Group A, which received sildenafil 0.5 mg/kg every 6 hours plus intravenous magnesium sulfate 25–50 mg/kg every 6 hours, or Group B, which received sildenafil 0.5 mg/kg every 6 hours alone. Clinical, oxygenation, and echocardiographic parameters were evaluated at baseline and during the first 72 hours of treatment. Results: Baseline demographic, neonatal, as well as echocardiographic characteristics were comparable among both groups. Pulmonary artery pressure was similar at baseline and after 24 hours, but became significantly lower in Group A after 48 hours (40.75±5.81 vs 46.1±7.31 mmHg, P=0.007) and 72 hours (35.7±5.03 vs 42.95±7.29 mmHg, P<0.001). Oxygen saturation improved significantly over time in Group A (P=0.02), whereas no significant temporal improvement occurred in Group B (P=0.55). Time to clinical response…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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