Magnesium Sulphate in Perinatal Asphyxia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Magnesium Sulphate in Perinatal Asphyxia: A Randomized Placebo Controlled Trial.

Conditions
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Perinatal Asphyxia , Moderate to Severe HIE

Intervention / Treatment
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* Drug: Magnesium sulphate
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Babies eligible for the study were: Term or post term Less than 6 hours of age and had 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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 6 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium sulphate, neurological outcome<br>Magnesium sulphate 250mg/kg after every 24 hours starting within 6 hours from birth | Drug: Magnesium sulphate<br>* 250 mg/kg/dose in 1 ml normal saline<br>|
| Placebo Comparator: Placebo<br>Placebo every 24 hours for 3 doses starting from 6 hours after birth | Drug: Normal saline<br>* 1 ml/kg/dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| good short term out come | Death and or abnormal neurological outcome at discharge | at discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abnormal neurological examination and abnormal CT Head |  | at discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asphyxia, perinatal, magnesium sulphate