Norepinephrine versus Dopamine for Septic Shock in Neonates: A Randomized Controlled Trial.

Objective: To assess the effect of norepinephrine (NE) vs dopamine (DA) as first-line vasoactive agent in neonates with fluid-refractory septic shock. Methods: In this randomized controlled trial, 80 neonates with fluid-refractory septic shock were allocated to receive either NE (n = 41) or DA (n = 39) as the first-line vasoactive drug. NE and DA were initiated at a dose of 0.2 and 10 μg/kg/min and escalated to a maximum dose of 0.3 and 15 μg/kg/min, respectively. The primary outcome was the proportion of neonates with shock reversal at 30 minutes of initiation of vasoactive support. Other outcomes included time to shock reversal, requirement of additional vasoactive drugs and steroids, changes in cerebral tissue oxygen saturation, and acid-base parameters and lactate levels at 6-8 and 24 hours. Incidence of mortality, hyperglycemia, tachycardia, and other morbidities were recorded. Results: Baseline characteristics were comparable between the 2 groups. The proportion of neonates with shock reversal at 30 minutes was 32% (13/41) and 46% (18/39) in NE and DA groups, respectively (relative risk 0.69, 95% CI 0.39-1.20, P = .19). Time to reversal of shock, need for additional vasoactive drugs and steroids, lactate levels, hyperglycemia, mortality, and other morbidities were comparable. However, neonates in the DA group had a higher incidence of tachycardia, lower cerebral tissue oxygen saturation, and lower pH at 24 hours of recruitment. Conclusions: In neonates with septic shock, NE and DA had comparable efficacy as a first-line vasoactive agent.

Background: Clinical trial registry of India, registration no: CTRI/2023/02/049357, registered prospectively on: 01/02/2023, https://trialsearch.who.int/.