Magnesium Sulphate in Perinatal Asphyxia (Magsulf)

Sheri Kashmir Institute of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Perinatal Asphyxia , Moderate to Severe HIE

Treatments: Drug: Magnesium sulphate; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00553072

SKIMS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 1 to 6 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Magnesium sulphate, neurological outcome

Active Comparator group

Description:

Magnesium sulphate 250mg/kg after every 24 hours starting within 6 hours from birth

Treatment:

Drug: Magnesium sulphate

Placebo

Placebo Comparator group

Description:

Placebo every 24 hours for 3 doses starting from 6 hours after birth

Treatment:

Drug: Normal saline