A randomized controlled trial of sodium bicarbonate in neonatal resuscitation-effect on immediate outcome.

UNLABELLED: Very little evidence is available that supports or disproves the use of medications in neonatal resuscitation. In this randomized controlled trial, we evaluated the effect of sodium bicarbonate given during neonatal resuscitation, on survival and neurological outcome at discharge. SUBJECTS AND METHODS: Consecutively born asphyxiated neonates continuing to need positive pressure ventilation at 5min of life received either sodium bicarbonate or 5% dextrose. The study group was given intravenous sodium bicarbonate solution 4ml/kg (1.8meq./kg) over 3-5min. This solution was prepared by diluting 7.5% sodium bicarbonate (0.9meq./ml) with distilled water in a 1:1 ratio. The placebo group received 4ml/kg of undiluted 5% dextrose at a similar rate. The surviving neonates were evaluated for their neurological status at discharge. Primary outcome variable: Death or abnormal neurological examination at discharge. Secondary outcome variables: Encephalopathy, multi-organ dysfunction, intraventricular haemorrhage (IVH) and arterial pH at 6h.
RESULTS: Twenty-seven babies were randomized to receive sodium bicarbonate (bicarb group) and 28 to receive 5% dextrose. Eighteen of the 27 (66.7%) babies in the bicarb group and 19 of the 28 babies (68%) in the dextrose group survived to discharge ( P=0.84 ). Twenty-eight percent of the survivors in the bicarb group and 32% of the survivors in the dextrose group were neurologically abnormal at discharge ( P=0.10 ). The composite primary outcome of death or abnormal neurological examination at discharge was similar in both groups (52% versus 54%, P=0.88 ). The incidence of encephalopathy (74% versus 63%), cerebral oedema (52% versus 30%), need for inotropic support (44% versus 29%), intraventricular haemorrhage (IVH) and the mean arterial pH at 6hrs were similar between the two groups.
CONCLUSION: Administration of sodium bicarbonate during neonatal resuscitation did not help to improve survival or immediate neurological outcome.

RCT Entities:   Population Interventions Outcomes