Normal Saline along with standard treatmentSovateltide along with standard treatment
Normal Saline along with standard treatment: Sovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm normal saline along with standard treatment will be given for active comparison.
Sovateltide along with standard treatment: Sovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm sovateltide along with standard treatment will be given for active comparison.
Study summary
Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a "Treatment for hypoxic-ischemic encephalopathy in neonates," which is a life-threatening condition. Sovateltide augments neuronal progenitor cell differentiation and better mitochondrial morphology and biogenesis to activate a regenerative response in the central nervous system. The only treatment for HIE is therapeutic hypothermia with limited success, and studies indicate that sovateltide may be beneficial in these patients.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Either sex with ≥ 36 weeks of gestational age
2. Receiving supportive management for perinatal asphyxia
3. 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.
4. Informed consent by one of the parents or a legal representative
Exclusion Criteria:
1. Gestational age \<36 weeks
2. Admitted to hospital 12-hours after birth
3. A genetic or congenital condition that affects neuronal development
4. TORCH infection
5. Neonatal sepsis
6. Complex congenital heart disease
7. Severe dysmorphic feature
8. Microcephaly (head circumference \< 2 Standard Deviations below mean for gestational age)
Primary outcome measure(s)
Percentage of patients with death or disability (moderate/severe) — 24 months Percentage of patients with death or disability (moderate/severe). Severe disability is defined as any of the following: a Bayley composite cognitive score \<70, a GMFCS grade of level 3 to 5, hearing impairment requiring hearing aids, or blindness (vision \<20/200). Moderate disability is defined as a composite cognitive score 70 - 84, in addition, one or more of the following: GMFCS grade of level 2, unilateral blindness (vision 20/200 in only one eye), or hearing impairment with no amplification/cochlear implant.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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