Using sildenafil to treat brain injury in newborns after asphyxia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of sildenafil, a drug commonly used for pulmonary hypertension, to repair brain injury in neonates suffering from hypoxic-ischemic encephalopathy (HIE) due to birth asphyxia. The study will enroll neonates who have undergone therapeutic hypothermia and will randomly assign them to receive either sildenafil or a placebo for seven days. The primary aim is to evaluate the efficacy of sildenafil in reducing brain injury as measured by MRI, while secondary aims include assessing the safety of the drug and its effects on cardiopulmonary hemodynamics. This multicenter, double-blind, placebo-controlled trial aims to provide critical insights into a potential new treatment for a condition with currently limited options.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital Colorado
  Denver, Colorado, United States Recruiting
• Montreal Children's Hospital
  Montreal, Quebec, Canada Recruiting
• Centre Hospitalier Universitaire Sainte-Justine
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Pia Wintermark, MD — Research Institute of the McGill University Health Centre (The Institute)
• Study coordinator: Pia Wintermark, MD
• Email: pia.wintermark@mcgill.ca
• Phone: +1-514-412-4452

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.