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Study identifier: NCT06098833 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Neonatal Encephalopathy  ·  Sponsor: Pia Wintermark

PhasePhase 2
Planned participants60
Who can joinAll sexes, 0 Minutes to 48 Hours
Healthy volunteersNo

About this study

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 suffered from asphyxia at birth. These studies also highlight the first promising signs that sildenafil may improve how the brains of these babies work, which is consistent with the abovementioned laboratory studies. On the basis of these previous researches, the investigators predict that sildenafil can repair the damage to a baby's brain. The investigators will test whether sildenafil can be safely given to a large group of human babies who suffer from asphyxia at birth, and will confirm whether sildenafil improves or not how their brains and hearts/lungs work. This project will enable to…

This description comes directly from the study's public registry record.

Talk to the study team

Pia Wintermark, MD  ·  +1-514-412-4452  ·  pia.wintermark@mcgill.ca

Gabriel Altit, MD  ·  +1-514-412-4452  ·  gabriel.altit@mcgill.ca

Always discuss trial participation with your own doctor first.

Locations (2)

Montreal Children's HospitalMontreal, Quebec, CanadaRecruiting
Centre Hospitalier Universitaire Sainte-JustineMontreal, Quebec, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT06098833