Health Condition 1: P111- Other specified brain damage due to birth injury Health Condition 2: P10-P15- Birth trauma Health Condition 3: P11- Other birth injuries to central nervous system Health Condition 4: P111- Other specified brain damage due to birth injury
Conditions
Interventions
Intervention1: Lyophilized Sovateltide Injection 30µg (PMZ-1620): Three doses of PMZ-1620 (each dose of 0.3 μg/kg body weight) to be administered as an IV bolus over one minute, at an interval of 3
Sponsors
Pharmazz India Private Limited
Eligibility
Inclusion 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: (a)Apgar score of (b)Need for resuscitation (chest compressions or mechanical ventilation) at birth (c)pH = 16 mmol/liter in the cord or arterial blood within 60 minutes of birth (d)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
Exclusion criteria: 1.Gestational age 2.Admitted to hospital12-hoursafter 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with death or disability (moderate/severe)Timepoint: Day-1 to 24 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of patients with brain injury (MRI or EEG evidence of brain injury).Timepoint: 14 days;Change in the proportion of patients with blindness or hearing impairmentTimepoint: 24 months;Incidence of sovateltide related adverse eventsTimepoint: 24 months;The number of patients not receiving complete treatment due to intolerance to sovateltideTimepoint: 7 days;Changes in Bayley Scales of Infant and Toddler DevelopmentScoresTimepoint: 24 months;Cognitive, Language, Motor, Social-Emotional, and General Adaptive Scales Score as assessed by Bayley Scales of Infant and Toddler Development (BSID)TM measuredTimepoint: at 6 months after initiation of treatment and then at every 6 months interval;Change in the proportion of children with disabling cerebral palsyTimepoint: 24 months;Change in the proportion of patients with seizures Clinical or electrical seizuresat birth, at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 7 days, 30 days, 6 months after initiation of treatment, and then at every 6 months intervalTimepoint: 24 months | — |
Countries
India
Contacts
Public ContactDr Sunil Gulati
Pharmazz India Private Limited
Outcome results
None listed