Status:
RECRUITING
Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia
Lead Sponsor:
Pia Wintermark
Conditions:
Neonatal Encephalopathy
Eligibility:
All Genders
Up to 48 years
Phase:
PHASE2
Brief Summary
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-threat...
Detailed Description
The investigators will enroll neonates with HIE treated with TH from NICUs in a multicentre, randomized, double-blind, placebo-controlled phase 2 clinical trial to evaluate the safety and efficacy of ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06098833
Start Date
July 1 2024
End Date
June 1 2028
Last Update
January 14 2025
Active Locations (2)
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1
Montreal Children's Hospital
Montreal, Quebec, Canada, H3C 0T3
2
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5