Perinatal Asphyxia , Moderate to Severe HIE
Conditions
Keywords
Asphyxia, perinatal, magnesium sulphate
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.
Interventions
DRUGMagnesium sulphate
250 mg/kg/dose in 1 ml normal saline
DRUGNormal saline
1 ml/kg/dose
Sponsors
Sheri Kashmir Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Hours to 6 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| good short term out come | at discharge | Death and or abnormal neurological outcome at discharge |
Secondary
| Measure | Time frame |
|---|---|
| abnormal neurological examination and abnormal CT Head | at discharge |
Countries
India
Outcome results
None listed