Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia
Neonatal Encephalopathy
About this trial
This is an interventional treatment trial for Neonatal Encephalopathy focused on measuring birth asphyxia, brain, hypoxic-ischemic encephalopathy, neonate, neuroprotection, neurorestoration, newborn, sildenafil
Eligibility Criteria
Inclusion Criteria: Male and female neonates meeting the criteria for induced hypothermia: Gestational age ≥36weeks and birth weight ≥1800g; Evidence of fetal distress, i.e., history of an acute perinatal event, cord pH ≤7.0 or base deficit 16 mEq/L; Evidence of neonatal distress, such as an Apgar score ≤5 at 10 minutes, postnatal blood gas pH obtained within the first hour of life ≤ 7.0 or base deficit ≤ - 16 mEq/L, or a continued need for ventilation initiated at birth and continued for at least 10 minutes; Evidence of moderate to severe neonatal encephalopathy by an abnormal neurological exam and/or an amplitude-integrated electroencephalogram (aEEG). They will receive whole-body cooling to an esophageal temperature of 33.5°C, initiated within the first 6 hours of life, continued for 72 hours, and then they will be slowly rewarmed using standard protocol. Evidence of brain injury on a brain magnetic resonance imaging (MRI) performed on day 2 of life. Exclusion Criteria: Neonates with complex congenital heart disease Neonates with cerebral malformations Neonates with genetic syndrome Neonates with intraventricular and/or intraparenchymal hemorrhage on MRI performed on day 2 of life Moribund infants not expected to survive
Sites / Locations
- Montreal Children's Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Sildenafil
Ora-Blend
Sildenafil per os twice a day for seven consecutive days (from day 2 of life to day 9 of life) if brain injury on day 2 of life (dose 1=2mg/kg/dose, dose 2=2.5mg/kg/dose, and doses 3-14=3mg/kg/dose)
Ora-Blend per os twice a day for seven consecutive days (from day 2 of life to day 9 of life) if brain injury on day 2 of life (dose 1=2mg/kg/dose, dose 2=2.5mg/kg/dose, and doses 3-14=3mg/kg/dose)