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Active, Not Recruiting

NCT Number: NCT04169191

Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Birth Asphyxia Asphyxia Neonatorum Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

0 day–2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Montreal Children's Hospital

Montreal, Quebec, H4A3J1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sildenafil citrate

Drug

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 outcomes

  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 outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: within first 10 days of life

    Peak Plasma Concentration (Cmax)

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Official study 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)

Acronym: SANE-02

Important dates

Study start
2019
Primary completion
2021
Study completion
2024
First posted
Nov 19, 2019
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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