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Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia

RecruitingPhase 2Ages 0 Minutes - 48 HoursAllPia Wintermark
NCT06098833 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Around the time of birth, some babies experience a condition called asphyxia, which means that their brain and other organs do not receive enough blood and/or oxygen to work properly. This life-threatening condition accounts for nearly 1 out of 4 deaths of all babies around the world, and often leads to severe brain damage, cerebral palsy, epilepsy, and trouble with learning and functioning in everyday life. At this time, no treatment is available to repair the brain damage caused by asphyxia. Excitingly, a drug called sildenafil (Viagra®) is already given safely to babies who suffer from increased blood pressure in their lungs' vessels. Recent studies using a laboratory model of asphyxia at birth suggest that sildenafil may also repair the brain damage caused by asphyxia. Similarly, recent small studies have shown that it is both feasible and safe to give sildenafil to human babies, who

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📋 Eligibility rules (as published)
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
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What it tests

  • Sildenafil
  • Ora-Blend
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Where

3 sites
Children's Hospital Colorado
Denver, United States
Montreal Children's Hospital
Montreal, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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