Norepinephrine Versus Dopamine as Initial Vasoactive Therapy in Neonatal Septic Shock: A Randomized Controlled Trial in a Tertiary Care Neonatal Intensive Care Unit in Eastern India.

Background Septic shock remains a major cause of neonatal morbidity and mortality, particularly in preterm and low birth weight neonates. Although dopamine was traditionally used as the first-line vasoactive agent in neonatal shock, norepinephrine has emerged as a potential alternative agent of late because of its potent vasoconstrictive effects and favourable hemodynamic profile. However, evidence comparing the efficacy of these agents in septic shock in neonates remains limited. Objective To compare the efficacy of norepinephrine and dopamine as the initial vasopressor in neonatal septic shock. Methods This study was a non-blinded parallel randomized controlled trial conducted between October 2020 and October 2022 in the neonatal intensive care unit of a tertiary care center in Odisha, India. Ninety neonates with septic shock were randomized into two groups: norepinephrine group (n=45) and dopamine group (n=45). Norepinephrine was initiated at 0.2 mcg/kg/min, while dopamine was started at 10 mcg/kg/min with escalation according to clinical response. The primary outcome was reversal of shock within 45 minutes of initiation of vasoactive therapy. Secondary outcomes included requirement of additional vasoactive drugs, need for mechanical ventilation, all-cause mortality by 28 days, and incidence of complications including intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), and retinopathy of prematurity (ROP). Results Baseline demographic and clinical characteristics of both groups were comparable. Reversal of shock at 45 minutes was achieved in 14 neonates (31.1%) in the norepinephrine group and 16 neonates (35.5%) in the dopamine group (p=0.65). Hemodynamic parameters including systolic blood pressure, diastolic blood pressure, and capillary refill time improved progressively in both groups without statistically significant intergroup differences. Requirement of additional vasoactive support was observed in 11 neonates (24.4%) in the norepinephrine group and 10 neonates (22.2%) in the dopamine group (p=0.80). Mechanical ventilation was required in 16 neonates (35.5%) in the norepinephrine group and 14 neonates (31.1%) in the dopamine group (p=0.65). All-cause mortality was comparable between the groups (15.5% vs. 13.3%; p=0.76). The incidence of short-term complications including IVH, NEC, BPD, and ROP was also similar between groups. Conclusion Norepinephrine and dopamine demonstrated comparable efficacy in achieving early reversal of neonatal septic shock, with no significant differences in mortality or short-term complications. Both agents may be considered suitable initial vasoactive therapies in neonatal septic shock. Larger multicentric studies are required to establish definitive evidence-based recommendations for vasoactive management in this population.