Effect of Hyperbaric Oxygen Therapy on Neonatal Hypoxic-Ischemic Encephalopathy
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 10
- 主要终点
- Number of Death or Moderate to Severe Disability Which is Graded According to Gross Motor Function Classification System （GMFCS）
研究概览
简要总结
The purpose of this study is to to evaluate the safety and efficacy of hyperbaric oxygen in term gestation newborn infants with hypoxic-ischemic encephalopathy..
详细描述
Hypoxic-ischemic encephalopathy (HIE) remains a major cause of neonatal death and long term disabilities. Data from animal studies have shown protective effects of hyperbaric oxygen therapy to impaired brain. Recently research priorities have moved from bench to bedside. Several studies have shown a trend for brain protection of hyperbaric oxygen therapy has emerged as a promising treatment for HIE. Therefore,the investigators organized a multi-centered randomized controlled trial of hyperbaric oxygen therapy in HIE newborn infants.
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 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn infants whose gestational age ≥37 weeks' gestation, weighing over 2500 g ;
- •Acute perinatal event (e.g., late or variable decelerations, cord prolapse, cord rupture, uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest)
- •With an Apgar score ≤ 3 at one minute and ≤5 at five minutes, and/or a potential of hydrogen of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of umbilical-cord blood or any blood during the first hour after birth.
- •Having moderate-to-severe encephalopathy (indicated by lethargy, stupor, or coma) and either hypotonia, abnormal reflexes (including oculomotor or pupillary abnormalities), an absent or weak suck, or clinical seizures, and/or have abnormal background activity of at least 20 minutes' duration or seizures on amplitude integrated electroencephalography
排除标准
- •A congenital and the hereditary disease, a chromosome abnormalities, and a congenital abnormality.
- •During the acute phases of intracranial and (or) fundus hemorrhage. o
- •Intracranial infection.
- •Pneumothorax.
- •Infants who have been received hypothermia.
研究组 & 干预措施
control
Newborns with hypoxic ischemic encephalopathy treated with intensive care only
hyperbaric oxygen
Newborns with hypoxic ischemic encephalopathy treated with intensive care and hyperbaric oxygen
干预措施: hyperbaric oxygen (Device)
结局指标
主要结局
Number of Death or Moderate to Severe Disability Which is Graded According to Gross Motor Function Classification System （GMFCS）
时间窗: 18 months of life
Number of Death or Moderate to Severe Disability Which is Graded According to
次要结局
- Number of Infants with Brain-stem Auditory Evoked Potentials Abnormalities at 3 Months of Life(3 months of life)
- Bayley Scales of Infant Development(6,12 and 18 months of life)
- Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities(3 months of life)
- Adverse Events That Are Related to Treatment(3 months of life)
- Number of Infants with Brain Magnetic Resonance Imaging Abnormalities(3 months of Lif)
- neonatal behavioral neurological assessment(7,14 and 28 days after birth)
- Gross Motor Function Classification System(18 months of life)