Dopamine versus norepinephrine in fluid-refractory septic shock among preterm neonates: a double-blind randomized controlled trial

The present study aims to compare the efficacy and safety of norepinephrine (NE) versus dopamine in achieving early (within 45 min of initiation) reversal of fluid-refractory septic shock in preterm neonates. A double-blind randomized controlled trial was conducted in a Level-III tertiary care hospital in Northern India. Fifty neonates born at a gestational age of <37 weeks and diagnosed with fluid-refractory septic shock till 28 days of life were randomly allocated to receive either dopamine infusion (10-20 μg/kg/min) or NE infusion (0.2-0.4 μg/kg/min). We found that the proportion of preterm neonates achieving early (within 45 min of initiation) reversal of septic shock was 11/26 (42.3%) in the dopamine group vs. 15/24 (62.5%) in the NE group, respectively [risk ratio (RR) 0.677; 95% confidence interval (CI) 0.392-1.168]. Among secondary outcomes, the proportion of neonates requiring additional vasoactive drugs was significantly less in the NE group, 8/24 (33.3%) vs. the dopamine group, 16/26 (61.5%), respectively (RR 1.846; 95% CI 1.000-3.509, P=.04). Additionally, the probability of requiring additional vasoactive drugs and remaining alive during the hospital stay were significantly higher in the NE group [hazard ratio (HR) 1.66; 95% CI 1.12-2.45, P=.01 by log-rank test]. There was no significant difference in other clinical outcomes. Among preterm neonates with fluid-refractory septic shock, NE (0.2-0.4 μg/kg/min) and dopamine (10-20 μg/kg/min) had comparable efficacy and safety.