Magnesium Sulphate in Perinatal Asphyxia

Sheri Kashmir Institute of Medical Sciences40 enrolled

Overview

Magnesium sulphate has been shown to be neuroprotective. The investigators hypothesize that magnesium sulphate infusion given to babies with perinatal asphyxia should improve outcome in the immediate neonatal period.

Magnesium sulphate has a neuroprotective potential as has been shown by many studied in pregnant ladies with eclampsia where it helped neonates also and in mothers with preterm labour where the incidence of cerebral palsy was less. We designed a randomised controlled trial on 40 neonates with severe perinatal asphyxia to see whether it helps in the short term outcome of these neonates.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Perinatal Asphyxia , Moderate to Severe HIE

Interventions

Magnesium sulphateDRUG

250 mg/kg/dose in 1 ml normal saline

Normal salineDRUG

1 ml/kg/dose

Eligibility

Sex: ALLMin age: 1 HourMax age: 6 Hours

Medical Language ↔ Plain English

Inclusion Criteria: * Babies eligible for the study were: 1. Term or post term 2. Less than 6 hours of age and had 3. severe perinatal asphyxia as manifested by any three of the following criteria. * History of fetal distress (late deceleration, Loss of beat to beat variability, fetal bradycardia, meconium stained amniotic fluid) * Need for immediate neonatal ventilation with bag and mask or through endotracheal intubation for 2 minutes or more after delivery * A 5-minute Apgar score of \< 6 * Base deficit 15 mEq/L in cord blood or admission arterial or cord blood pH 4.Moderate to severe encephalopathy Exclusion Criteria: * Patients with severe IUGR * Any condition unrelated to asphyxia * Maternal prenatal magnesium administration * Metabolic disorder * Chromosomal anomalies; and * Congenital malformations were excluded from the study

Locations (1)

Sheri-Kashmir Institute of Medical Scienceds

Srinagar, Jammu and Kashmir, India

Outcomes

Primary Outcomes

good short term out come

Death and or abnormal neurological outcome at discharge

Time frame: at discharge

Secondary Outcomes

abnormal neurological examination and abnormal CT Head

Time frame: at discharge

Data from ClinicalTrials.gov

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