Magnesium sulfate as an adjunct to cooling of babies who do not cry at birth.
Phase 3
- Conditions
- Health Condition 1: P916- Hypoxic ischemic encephalopathy [HIE]Health Condition 2: null- Term infants with Hypoxic Ischemic Encephalopathy
- Registration Number
- CTRI/2018/06/014594
- Lead Sponsor
- JIPMER Puducherry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
Infants more than 6 hours of age
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eonatal 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 Outcome Measures
Name Time Method a.Neonatal mortality <br/ ><br>b.Major neurodevelopmental disability at 1 year of age <br/ ><br>c.Hospital course and discharge status-seizure, Anti-epileptic requirement <br/ ><br>d.Adverse effects-Hypotension, respiratory depression, Hypermagnesemia <br/ ><br>e.Oxidative stress marker ( serum level of Malondialdehyde and Total antioxidant status) <br/ ><br> <br/ ><br>Timepoint: Neonatal mortality-28 days of life <br/ ><br>Major neurodevelopmental outcome-1 year of age <br/ ><br>Hospital course and discharge status-at discharge <br/ ><br>adverse effects-first 72 hours of life <br/ ><br>Oxidative stress marker-at birth and at 72 hours of life <br/ ><br>