Volume expansion with Ringers Lactate versus Normal Saline in neonates with shock requiring fluid therapy an open labelled randomized controlled trial

Neonates who fulfil the inclusion criteria will be randomized after obtaining consent from parents. Babies requiring volume expansion will receive either Ringer’s Lactate or Normal Saline at 10ml/kg over 30-60 minutes and will be assessed after completion of the first fluid bolus for resolution of shock or if there is a need for another bolus/vasopressor like Dopamine or Dobutamine based on clinical criteria. Blood gas will be done at randomization to corroborate clinical findings and changes in blood gas components, like lactate and bicarbonate, will be documented. Cardiac output will be assessed before/during fluid therapy, and the response to fluid therapy will also be documented. All data will be entered on structured proforma. 

The data will be presented as frequency and percentage for categorical variables. For continuous variables, we will report the mean with standard deviation or the median with interquartile range (IQR), depending on the distribution of the data. A Chi-square test will be used to compare two groups for categorical outcomes, while a Student’s t-test will be applied for continuous outcomes, where p values < 0.05 will be considered significant. Outcomes will be stratified as per the type of shock in the subgroup analysis. Additionally, logistic random effect regression will be used for binary outcomes, and linear random effect regression will be applied for continuous data outcomes. Data will be analysed using JAMOVI and R programme.