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New treatment option for Neonatal Encephalopathy
Official title Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia
ClinicalTrials.gov ID: NCT06098833
What this study is testing
What is Sildenafil?
Sildenafil is an investigational medicine, given as a twice-daily, being studied as a potential treatment for neonatal encephalopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 48
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- Evidence of brain injury on a brain magnetic resonance imaging (MRI) performed on day 2 of life.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 minutes to 48 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.