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)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Hypotension
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Sildenafil
干预措施: Sildenafil Citrate (Drug)
结局指标
主要结局
Hypotension
时间窗: within first 10 days of life
Number of participants with hypotension
Death
时间窗: within first 10 days of life
Number of participants with death
次要结局
- Peak Plasma Concentration (Cmax)(within first 10 days of life)
研究者
Pia Wintermark
Associate Professor of Pediatrics
McGill University Health Centre/Research Institute of the McGill University Health Centre