Actively Recruiting
Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury After Birth Asphyxia A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Effects on Brain and Heart Function
Led by Pia Wintermark · Updated on 2025-01-14
60
Participants Needed
2
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying neonatal encephalopathy caused by birth asphyxia, a condition where a baby's brain and organs receive insufficient blood or oxygen around birth. This serious condition can lead to brain damage, cerebral palsy, epilepsy, and learning difficulties. Currently, no treatment exists to repair this brain damage. Sildenafil, a drug safely used for newborns with lung blood pressure issues, has shown promise in lab studies and small human trials for repairing brain injury from asphyxia. This trial is a phase 2, multicenter, randomized, double-blind, placebo-controlled study enrolling newborns with moderate to severe hypoxic-ischemic encephalopathy (HIE) treated with therapeutic hypothermia. Babies with brain injury confirmed by MRI on day 2 will be randomly assigned to receive oral sildenafil or placebo twice daily for seven days, starting from day 2 to day 9 of life. Sildenafil doses will increase over time from 2 mg/kg to 3 mg/kg per dose. Participants will undergo brain MRI scans on day 2 and day 30 to assess brain injury changes. Heart and lung function will also be evaluated on day 4. Safety will be monitored by tracking adverse events. The study will determine whether sildenafil can safely improve brain injury and cardiopulmonary function in these newborns, potentially offering a new treatment to improve their future health and development.
CONDITIONS
Official Title
Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female newborns meeting criteria for induced hypothermia
- Gestational age 36 weeks or more
- Birth weight 1800 grams or more
- Evidence of fetal distress such as acute perinatal event, cord pH 7.0 or lower, or base deficit 16 mEq/L or more
- Evidence of neonatal distress including Apgar score 5 or less at 10 minutes, blood gas pH 7.0 or lower within first hour, or need for ventilation for at least 10 minutes
- Moderate to severe neonatal encephalopathy by abnormal neurological exam or brain monitoring (aEEG)
- Undergoing whole-body cooling to 33.56C within first 6 hours of life for 72 hours followed by rewarming
- Brain injury confirmed by MRI on day 2 of life
You will not qualify if you...
- Newborns with complex congenital heart disease
- Newborns with brain malformations
- Newborns with genetic syndromes
- Newborns with brain hemorrhage on day 2 MRI
- Babies who are moribund and not expected to survive
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Montreal Children's Hospital
Montreal, Quebec, Canada, H3C 0T3
Actively Recruiting
2
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
Research Team
P
Pia Wintermark, MD
G
Gabriel Altit, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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