Magnesium Sulphate in Perinatal Asphyxia

Phase 3

Completed

• Conditions: Perinatal Asphyxia , Moderate to Severe HIE
• Interventions: Drug: Magnesium sulphate; Drug: Normal saline

• Registration Number: NCT00553072
• Lead Sponsor: Sheri Kashmir Institute of Medical Sciences

Brief Summary

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

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 Timeline

• Study Start: 2004-09
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Study First Submitted: 2007-11-02
• Study First Submitted QC: 2007-11-02
• Study First Posted: 2007-11-04
• Status Verified: 2013-11
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium sulphate, neurological outcome	Magnesium sulphate	Magnesium sulphate 250mg/kg after every 24 hours starting within 6 hours from birth
Placebo	Normal saline	Placebo every 24 hours for 3 doses starting from 6 hours after birth

Primary Outcome Measures

Name	Time	Method
good short term out come	at discharge	Death and or abnormal neurological outcome at discharge

Secondary Outcome Measures

Name	Time	Method
abnormal neurological examination and abnormal CT Head	at discharge

Trial Locations

Locations (1)

Sheri-Kashmir Institute of Medical Scienceds; 🇮🇳 Srinagar, Jammu and Kashmir, India