Health Condition 1: P916- Hypoxic ischemic encephalopathy [HIE] Health Condition 2: null- Term infants with Hypoxic Ischemic Encephalopathy
Conditions
Interventions
Intervention1: Magnesium sulfate and therapeutic hypothermia: Term infants with hypoxic ischemic encephalopathy will receive magnesium sulfate as an adjunct to therapeutic hypothermia
Magnesium sulfa
Sponsors
JIPMER Puducherry
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria A plus B and any one of C A. Inborn babies with Gestational age more than or equal to 37 weeks with Arterial blood gas(Umbilical cord or 1st postnatal hour) pH less than or equal to 7.0 or base deficit more than or equal to 12 meq/L B. Presence of moderate to severe encephalopathy C. Any one of the below mentioned criteria: 1. APGAR less than or equal to 5 at 10 minutes 2. Evidence of fetal distress 3. Assisted ventilation for at least 10 minutes after birth 4. Evidence of any organ dysfunction 5. History of acute perinatal event
Exclusion criteria
Exclusion criteria: Exclusion criteria Infants more than 6 hours of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neonatal mortality and/or abnormal neurodevelopmental outcome at 1 year of ageTimepoint: Neonatal mortality at 28 days of life and abnormal neurodevelopmental outcome at 1 year of age | — |
Secondary
| Measure | Time frame |
|---|---|
| a.Neonatal mortality b.Major neurodevelopmental disability at 1 year of age c.Hospital course and discharge status-seizure, Anti-epileptic requirement d.Adverse effects-Hypotension, respiratory depression, Hypermagnesemia e.Oxidative stress marker ( serum level of Malondialdehyde and Total antioxidant status) Timepoint: Neonatal mortality-28 days of life Major neurodevelopmental outcome-1 year of age Hospital course and discharge status-at discharge adverse effects-first 72 hours of life Oxidative stress marker-at birth and at 72 hours of life | — |
Countries
India
Contacts
Public ContactDr Adhisivam B
JIPMER, Puducherry
Outcome results
None listed