Neuroprotective Outcomes of Magnesium Sulfate in Neonates With Hypoxic-Ischemic Encephalopathy (HIE) at Tertiary Care Hospital of Karachi

Brief Summary

Detailed Description

Objective: • To determine the neuroprotective outcomes of intravenous magnesium sulphate in neonates with hypoxic ischemic encephalopathy (HIE) at a tertiary care hospital of Karachi. Methodology: * Study Setting: This is a prospective study; and will be conducted at tertiary care hospital of Karachi (Sindh Institute of Child Health and Neonatology, K-5). * Study Design: Rndomized clinical Trial * Target Population: The study population will be all term and near term newborns (≥35 completed weeks) with moderate to severe HIE. * Inclusion Criteria: All Late preterm and term newborn with hypoxic ischemic encephalopathy (HIE) on basis of sarnat score and reaching in our unit within 6 hours of life will be the part of our trial. * Exclusion Criteria: * Newborns of less than 34 weeks, with dimorphism, comorbidities or arriving after 6 hours of birth, will be excluded. * Pre-existing medical conditions that may interfere with the assessment of neuroprotective outcomes. * Congenital anomalies or genetic disorders affecting neurological function. * Allergy or known adverse reactions to magnesium sulfate. * Participation in another concurrent clinical trial involving investigational drugs or interventions. * Inability to obtain informed consent from parents or guardians. * Medical Intervention: Magnesium sulphate as infusion will be commenced to cases. Control will be treated as per unit protocol. Sample Size: Sample size was calculated using WHO software with the following assumptions: Level of significance α=0.05 Power of study = 80 Anticipated population proportion P1 = 0.657 Anticipated population proportion P2 = 0.3757 Desired precision = 5 Required sample size 51 for each population (cases 51 and control 51) so, the total 102 is the minimum sample

Primary Outcomes