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Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia (SANE-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04169191
Recruitment Status : Recruiting
First Posted : November 19, 2019
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
Pia Wintermark, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
The investigators will determine the maximum tolerable dose of sildenafil and establish the pharmacokinetic and pharmacodynamic profile of sildenafil in human asphyxiated neonates treated with hypothermia. They will use a 3+3 design to escalate the sildenafil dose up to 6 mg/kg/day (3mg/kg/dose q12h) in asphyxiated neonates demonstrating brain injury despite hypothermia treatment and assess whether we observe any beneficial effects of sildenafil on their brain and cardiopulmonary hemodynamics, without causing serious adverse events

Condition or disease Intervention/treatment Phase
Birth Asphyxia Drug: Sildenafil Citrate Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 3+3 design to escalate the sildenafil dose up to 6 mg/kg/day (3mg/kg/dose q12h)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia: An Open-label Dose-finding Clinical Trial (Phase Ib Study)
Actual Study Start Date : September 19, 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sildenafil Drug: Sildenafil Citrate
Cohort 1 of 3-6 neonates: 1st dose of 2mg/kg/dose, 2nd dose of 2.5 mg/kg/dose, and subsequent doses of 2.5mg/kg/dose q12h (= 5 mg/kg/day from dose #2) Cohort 2 of 3-6 neonates: 1st dose of 2mg/kg/dose, 2nd dose of 2.5 mg/kg/dose, 3rd dose of 3mg/kg/dose, and subsequent doses of 3mg/kg/dose q12h (= 6 mg/kg/day from dose #3) dose expansion phase in up to 5-15 asphyxiated neonates




Primary Outcome Measures :
  1. Death [ Time Frame: within first 10 days of life ]
    Number of participants with death

  2. Hypotension [ Time Frame: within first 10 days of life ]
    Number of participants with hypotension


Secondary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: within first 10 days of life ]
    Peak Plasma Concentration (Cmax)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female neonates meeting the criteria for induced hypothermia:

    • Gestational age ≥ 36 weeks and birth weight ≥ 1800 g;
    • 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).
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04169191


Contacts
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Contact: Pia Wintermark, MD 514-412-4452 pia.wintermark@mcgill.ca

Locations
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Canada, Quebec
Montreal Children's Hospital Recruiting
Montréal, Quebec, Canada, H4A3J1
Contact: Pia Wintermark, MD    514-41-4452      
Principal Investigator: Pia Wintermark, MD         
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
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Responsible Party: Pia Wintermark, Associate Professor of Pediatrics, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT04169191    
Other Study ID Numbers: SANE-02
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make individual participant data (IPD) available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Asphyxia Neonatorum
Asphyxia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Death
Pathologic Processes
Infant, Newborn, Diseases
Sildenafil Citrate
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents