Hydrogen In Neonatal Encephalopathy (HIE) Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 54
- 主要终点
- Hydrogen Gas Adminstration Safety
研究概览
简要总结
Despite advances in neonatal care, moderate-to-severe acute perinatal HIE in late preterm and term infants remains a cause of mortality, neurological injury, and long-term neurodevelopmental disability. The current standard of care includes therapeutic hypothermia for 72 hours, but 40-50% of infants will die or suffer significant neurodevelopmental impairment. It has been shown that administration of hydrogen gas (H2) significantly diminishes ischemic injury in swine, and that H2 administration at the dose and duration proposed herein is well-tolerated in healthy adults. The purpose of this project is to test the feasibility and safety of H2 administration as an adjunct to therapeutic hypothermia in infants with HIE. Under exemption from informed consent, infants with severe, acute brain injury at birth will be randomized to standard therapy with or without the administration of 2% hydrogen in gases administered via the ventilator, non-invasive ventilation, or nasal cannula for 72 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 2 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born ≥36 weeks gestation.
- •Any one of the following:
- •sentinel event prior to delivery, such as uterine rupture, profound fetal bradycardia, or cord prolapse
- •low Apgar scores (≤ 5 at 10 minutes of life)
- •prolonged resuscitation at birth (chest compressions and/or intubation and/or mask ventilation at 10 minutes)
- •severe acidosis (pH < 7.0 from cord or neonate blood gas within 60 minutes of birth)
- •abnormal base excess (≤ -16 mEq/L from cord gas or neonate blood gas within 60 minutes of birth)
- •Moderate or severe encephalopathy present in the first 2 hours of life.
- •Intubated and mechanically ventilated at the time of enrollment.
排除标准
- •Enrollment in the opt-out program.
- •Presence of known cyanotic congenital heart disease.
- •Presence of known or suspected genetic/chromosomal syndrome or multiple congenital anomalies.
- •Presence of known congenital malformation that is expected to require urgent surgical intervention in the neonatal period, including congenital diaphragmatic hernia (CDH), gastroschisis, omphalocele, intestinal atresia, or imperforate anus.
- •Presence of antenatally diagnosed central nervous system malformation, including hemorrhage, hydrocephalus, or structural anomaly of the brain (eg. polymicrogyria).
- •Need for high frequency ventilation (HFV) at time of enrollment.
- •Patients receiving respiratory support via Drager Babylog ventilators.
- •Study enrollment and randomization after 2 hours of age
研究组 & 干预措施
Hydrogen Gas (H2) Intervention
Under exemption from informed consent, infants with severe, acute brain injury at birth will be randomized to standard therapy with the administration of 2% hydrogen in gases administered via the ventilator, non-invasive ventilation, or nasal cannula for 72 hours
干预措施: Hydrogen Gas (H2) (Drug)
Standard of Care
Under exemption from informed consent, infants with severe, acute brain injury at birth will be randomized to standard therapy with no study intervention
结局指标
主要结局
Hydrogen Gas Adminstration Safety
时间窗: 30 days post randomization
The incidence rate of Study AEs per day during the first 30 days post-randomization that have been classified as treatment-related or possibly treatment-related will be tracked.
Hydrogen Gas Adminstration Feasibility
时间窗: 72 hours post randomization
To establish the feasibility of H2 administration in infants with HIE, we will compute the percentage of the first 72 hours (starting at the time of randomization) in which H2 gas was administered
次要结局
- Evidence of Brain Injury on Clinically Ordered Imaging(3-7 days post randomization)
- Markers of Ischemic Injury(0, 1, 2, 3, and 4 days post randomization)
- Survival(post-randomization through 6 months of age)
- Neurodevelopmental Outcome(24-36 months of age)
研究者
Brian Kalish
Neonatologist, Assistant Professor of Pediatrics
Boston Children's Hospital