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

Abstract

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.

Keywords: dopamine; neonatal intensive care unit; norepinephrine; preterm; septic shock.