Normal saline and Ringers lactate in neonatal shock

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Normal Saline: Neonates randomised to Normal saline group will receive 10 ml per kg of Normal saline intravenously over 30 min Control Intervention1: Ringers Lactate: Neonates randomised to Ringers lactate group will receive 10 ml per kg intravenous Ringers lactate over 30 min CONDITION: Health Condition 1: P84‐ Other problems with newborn PRIMARY OUTCOME: Proportion of Neonates with hyperchloremic metabolic acidosis within the first 28 days from randomization in neonates receiving crystalloids as an initial fluid bolus for management of shockTimepoint: Till discharge of death SECONDARY OUTCOME: Coagulopathy requiring transfusion of fresh frozen plasma / cryoprecipitateTimepoint: Till discharge of death Correlation between increased velocity time integral variability before the intervention and response to fluid therapy and vasoactive inotropic scoreTimepoint: Till discharge of death Duration of hospital stayTimepoint: Till discharge of death Incidence and duration of vasopressor therapyTimepoint: Till discharge of death Incidence, type and duration of respiratory supportTimepoint: Till discharge of death Lactate levels in both the groups before and 1 hour after initiation of therapy.Timepoint: Till discharge of death MortalityTimepoint: Till Death Proportion of neonates with acute kidney injury (AKI) in both the groupsTimepoint: TIll discharge or death Proportion of neonates with metabolic acidosis in both the groupsTimepoint: Till discharge or death Vasoactive inotropic score in both the groupsTimepoint: Till discharge of death INCLUSION CRITERIA: Neonates with gestational age greater than 28 weeks or birth weight more than 1 Kg, Age less than 28 postnatal days, Shock as judged by the treating clinician (As per study definition) and parental consent.
Epistemonikos ID: 5df72d2aebacfed9aa29851e543a8b5ffb3f236a
First added on: Oct 08, 2026