Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
Hypoxic-Ischemic Encephalopathy, Neonatal Asphyxia, Neonatal Encephalopathy
About this trial
This is an interventional treatment trial for Hypoxic-Ischemic Encephalopathy focused on measuring Hypoxic-Ischemic Encephalopathy, Cerebral Asphyxia, Neonatal Encephalopathy
Eligibility Criteria
Inclusion Criteria:
- Either sex with ≥ 36 weeks of gestational age
- Receiving supportive management for perinatal asphyxia
Perinatal depression, based on at least one of the following:
- Apgar score of <5 at 10 minutes
- Need for resuscitation (chest compressions or mechanical ventilation) at birth
- pH <7.00 or base deficit ≥ 16 mmol/liter in the cord or arterial blood within 60 minutes of birth
- Moderate/severe encephalopathy evident by at least 3 of 6 modified Sarnat criteria, present between 1 to 6 hours of birth.
- Informed consent by one of the parents or a legal representative
Exclusion Criteria:
- Gestational age <36 weeks
- Admitted to hospital 12-hours after birth
- A genetic or congenital condition that affects neuronal development
- TORCH infection
- Neonatal sepsis
- Complex congenital heart disease
- Severe dysmorphic feature
- Microcephaly (head circumference < 2 Standard Deviations below mean for gestational age)
Sites / Locations
- Father Muller Medical College HospitalRecruiting
- Christian Medical College and HospitalRecruiting
- Niloufer Hospital
- GSVM Medical College
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Normal Saline + Standard of care
Sovateltide + Standard of care
Patients will receive the best available standard of care. Normal saline will be administered as an intravenous bolus over one minute every 3 hours on day 1, day 3, and day 6 post randomizations.
Patients will receive the best available standard of care. Dose of sovateltide (0.3 µg/kg) will be administered as an intravenous bolus over one minute every 3 hours on day 1, day 3, and day 6 post randomizations.