Effect of Sovateltide for hypoxic-ischemic encephalopathy in neonates
- Conditions
- Other specified brain damage due to birth injury, (2) ICD-10 Condition: P10-P15||Birth trauma, (3) ICD-10 Condition: P11||Other birth injuries to central nervous system, (4) ICD-10 Condition: P111||Other specified brain damage due to birth injury,
- Registration Number
- CTRI/2023/02/049358
- Lead Sponsor
- Pharmazz India Private Limited
- Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, phase-II study to assess the safety and efficacy of sovateltide for the treatment of perinatal asphyxia caused hypoxic-ischemic encephalopathy (HIE) in neonates.
This protocol is designed to develop a novel first-in-class treatment for hypoxic-ischemic encephalopathyin neonates.
For an individual patient, the duration of the study will be 24 months. At visit 1, a total of 40 patients with perinatal asphyxia/perinatal depression will be randomized 1:1 into 2 treatment groups after meeting the eligibility criteria. An Interactive Web Response System (IWRS) will be used to randomize the eligible patient to the treatment groups.
Group 1: Sovateltide + Supportive treatment for perinatal asphyxia
Group 2: Normal Saline (Equal volume) + Supportive treatment for perinatal asphyxia
Sovateltide or saline will be administered as an IV bolus dose over 1 minute. In the sovateltide group, 3 doses of sovateltide, at 0.3 μg/kg body weight will be administered as an (IV) bolus over 1 minute every 3 hours ± 1 hour on day 1, 3, and day 6 (total dose/day: 0.9 µg/kg body weight). In the saline group, 3 doses of an equal volume of normal saline will be administered as an IV bolus over 1 minute every 3 hours ± 1 hour on days 1, 3, and day 6 post-randomization. In both treatment groups, patients will be provided supportive treatment for perinatal asphyxia. Every effort will be made to have drug administration at the same time on days 1, 3 and, 6.
Each patient will be monitored closely throughout his/her hospitalization and will be followed for 24 months from randomization. Each subject will be assessed for efficacy and safety parameters over 24 months from randomization.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 40
- 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 <5 at 10 minutes (b)Need for resuscitation (chest compressions or mechanical ventilation) at birth (c)pH <7.00 or base deficit ≥ 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.
1.Gestational age <36 weeks 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 < 2 SDs below mean for gestational age).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with death or disability (moderate/severe) Day-1 to 24 Months
- Secondary Outcome Measures
Name Time Method Change in the proportion of children with disabling cerebral palsy 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 interval 24 months Cognitive, Language, Motor, Social-Emotional, and General Adaptive Scales Score as assessed by Bayley Scales of Infant and Toddler Development (BSID)TM measured at 6 months after initiation of treatment and then at every 6 months interval Changes in Bayley Scales of Infant and Toddler DevelopmentScores 24 months The number of patients with brain injury (MRI or EEG evidence of brain injury). 14 days Change in the proportion of patients with blindness or hearing impairment 24 months Incidence of sovateltide related adverse events 24 months The number of patients not receiving complete treatment due to intolerance to sovateltide 7 days
Trial Locations
- Locations (5)
Father Muller Medical College Hospital
🇮🇳Bangalore, KARNATAKA, India
Belagavi Institute of Medical Sciences
🇮🇳Belgaum, KARNATAKA, India
Christian Medical College and Hospital
🇮🇳Ludhiana, PUNJAB, India
Kanchi Kamakoti Childs Trust Hospital
🇮🇳Chennai, TAMIL NADU, India
King Georges Medical University
🇮🇳Lucknow, UTTAR PRADESH, India
Father Muller Medical College Hospital🇮🇳Bangalore, KARNATAKA, IndiaDrPavan HegdePrincipal investigator9845088116pavanhegde@hotmail.com