Hypoxic-Ischemic Encephalopathy Therapy Optimization for Better Neuroprotection With Inhalative CO2 in Asphyxiated, Cooled, Mechanically Ventilated Neonates at Risk for Hypocapnia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Percentage of time spent in the desired pCO2 range of 40-60 mmHg (temp. corrected) during CO2 inhalation.
研究概览
简要总结
This is a Phase I, open-label, single center trial to evaluate the feasibility and safety of low concentration CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of hypocapnia with The hypothesis is that hypocapnia, which is driven by hyperventilation in the presence of metabolic acidosis, is deleterious to the injured brain and can be safely avoided with low concentration CO2 inhalation.
详细描述
Specific aims:
- To test the feasibility of low concentration inhalative CO2 gas mixture (5% CO2 + 95% air) administration to achieve a desired range of pCO2 of 40-60 mmHg in asphyxiated, cooled, mechanically ventilated newborns at risk of hypocapnia with moderate to severe hypoxic-ischemic encephalopathy.
- To test the safety of CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of hypocapnia with moderate to severe hypoxic-ischemic encephalopathy.
Term infants (≥ 36 weeks of gestation) will have to be at risk of hypocapnia to be eligible, as defined by a temperature corrected pCO2 ≤ 40 mmHg in blood gas analysis, at any time within six hours of life.
The gas mixture will be administered through patient circuits in conventional ventilators. Administered CO2 level will be closely monitored at the inhalation circuit (constant 5% = 36 mmHg). Blood gas samples will be taken hourly to ensure targeted and tolerable pCO2 levels.
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
- — 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At any time within six hours of life the temperature corrected pCO2 is less than or equal to 40 mmHg after the parameters of mechanical ventilation is set according to standard protocol (SIMV+VG 5ml/kg, fr 20/min, PEEP 5 H20cm, Ti 0,35-0,45 sec).
- •Moderate hypoxic- ischaemic encephalopathy, fulfilling TOBY criteria (A, B, C).
- •< 6th hours of life
- •Hypothermia treatment
- •Parental consent form
- •Spontaneous breathing
- •Endotracheal intubation
- •AUC, VUC in place
排除标准
- •Major birth defect
- •Meconium aspiration syndrome
- •Need for combined catecholamine therapy
- •FiO2 > 40%
- •Htc < 35%
- •Acid-base status: pH < 6.8, lactate > 15mM
- •Excessive bicarbonate administration during initial stabilization (> 1mmol/kg)
结局指标
主要结局
Percentage of time spent in the desired pCO2 range of 40-60 mmHg (temp. corrected) during CO2 inhalation.
时间窗: 3 days
次要结局
- Time until the end point of metabolic acidosis (BE > -5 mmol/L)(During CO2 inhalation (max. 12 hours))
- Death(Within one month)
- Severe hypotension (mean arterial pressure less than 25 mmHg), despite full inotrope support and volume replacement.(During therapeutic hypothermia (max. 72 hours))
- Preserved fractional anisotropy measured on diffusion weighted MRI(Within seven days)
- Intracranial haemorrhage detected by MRI(Within seven days)
- Reduction in Lac/NAA ratio on magnetic resonance spectroscopy(Within seven days)
- Number of seizures, either detected clinically or by amplitude integrated EEG monitoring(Within one week)
- Time until the end point of acidosis (pH > 7.25)(During therapeutic hypothermia (max. 72 hours))
研究者
Ágnes Jermendy
assistant lecturer
Semmelweis University