Trial | NCT00553072  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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 Started
Sep 30
2004
Primary Completion
Aug 31
2006
Study Completion
Aug 31
2006
Last Update
Oct 14
2016
Estimate

Drug Normal saline

1 ml/kg/dose

Drug Magnesium sulphate

250 mg/kg/dose in 1 ml normal saline

Magnesium sulphate, neurological outcome Active Comparator

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

Placebo Placebo Comparator

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

Criteria 

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
No Results Posted