Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy

Launched by PHARMAZZ, INC. · Aug 22, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called sovateltide for babies with a serious condition known as hypoxic-ischemic encephalopathy (HIE), which can happen when a baby doesn’t get enough oxygen during or right after birth. Sovateltide aims to help the brain recover by supporting the growth of new brain cells and improving how these cells work. Currently, the main treatment for HIE is cooling therapy, but its success can be limited, so researchers hope that sovateltide may offer a better solution.

To be eligible for this trial, babies need to be at least 36 weeks old and must be receiving care for perinatal asphyxia, which is a lack of oxygen at birth. They should also show certain signs of being affected by HIE, like needing help breathing or having a low score indicating distress after birth. Parents or legal representatives will need to provide informed consent for their participation. If eligible, families can expect to be closely monitored as part of the study, where the safety and effectiveness of sovateltide will be assessed. This trial is currently recruiting participants, and all genders are welcome.

Gender

ALL

Eligibility criteria

• 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)