Magnesium Sulphate in Perinatal Asphyxia: A Randomized Placebo Controlled Trial.
Overview
- Phase
- Phase 3
- Intervention
- Magnesium sulphate
- Conditions
- Perinatal Asphyxia , Moderate to Severe HIE
- Sponsor
- Sheri Kashmir Institute of Medical Sciences
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- good short term out come
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Dr.Mushtaq
Professsor
Sheri Kashmir Institute of Medical Sciences
Eligibility 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
Arms & Interventions
Magnesium sulphate, neurological outcome
Magnesium sulphate 250mg/kg after every 24 hours starting within 6 hours from birth
Intervention: Magnesium sulphate
Placebo
Placebo every 24 hours for 3 doses starting from 6 hours after birth
Intervention: Normal saline
Outcomes
Primary Outcomes
good short term out come
Time Frame: at discharge
Death and or abnormal neurological outcome at discharge
Secondary Outcomes
- abnormal neurological examination and abnormal CT Head(at discharge)