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430 : Sildenafil administration to treat neonatal encephalopathy (SANE-01) and repair brain injury secondary to birth asphyxia: A randomized, double-blind, placebo-controlled pilot phase Ib study

Researchers

Presenter

  • Pia Wintermark

Principal Investigators

  • Anie Lapointe

  • Robin H. Steinhorn

  • Emmanouil Rampakakis

  • Juergen Burhenne

  • May Khairy

  • Gabriel Altit

  • Marie-Therese Adamo

  • Patrick Colin

  • Walter E. Haefeli

Medical Centers

  • McGill University Faculty of Medicine and Health Sciences, Montreal, PQ, Canada

  • Heidelberg University Hospital, Heidelberg, Baden-Wurttemberg, Germany

  • CHU Ste-Justine, Montréal, PQ, Canada

  • Department of Clinical Pharmacology and Pharmacoepidemiology / Heidelberg University Hospital, Heidelberg, Baden-Wurttemberg, Germany

  • University of California, San Diego and Rady Children's Hospitaliversity of California, San Diego School of Medicine, San Diego, CA, United States

  • University of Montreal, McGill University Health Centre, Montreal, PQ, Canada

Locations

  • Canada

  • United States

  • Germany

Companies

  • N/A

Study Components

Therapeutic Area

  • Central Nervous System (CNS)

Disease

  • Hypoxic-ischemic encephalopathy

Biomarkers

  • N/A

Drug/Treatment

  • Sildenafil citrate

Outcome

  • N/A


Study Design

  • Randomized

  • Safety

  • Placebo Control

  • Pharmacokinetics

  • Double Blind/Blinded

  • Controlled

Phase

  • I

Study Id's

  • N/A

Sponsors

  • N/A

Result

  • N/A