Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy
- Conditions
- Hypoxic-ischemic Encephalopathy
- Registration Number
- NCT02894866
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- Brief Summary
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..
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of Death or Moderate to Severe Disability Which is Graded According to Gross Motor Function Classification System （GMFCS） 18 months of life Number of Death or Moderate to Severe Disability Which is Graded According to
- Secondary Outcome Measures
Name Time Method Number of Infants with Brain-stem Auditory Evoked Potentials Abnormalities at 3 Months of Life 3 months of life Number of Infants with Brain-stem Auditory Evoked Potentials
Bayley Scales of Infant Development 6,12 and 18 months of life Bayley Scales of Infant Development
Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities 3 months of life Number of Infants with abnormal ambulatory electroencephalography monitoring
Adverse Events That Are Related to Treatment 3 months of life fundus examination by ophthalmofunduscope to evaluate retinopathy of prematurity，chest radiograph to evaluate pneumothorax, and monitoring vital signs by neonatal monitor
Number of Infants with Brain Magnetic Resonance Imaging Abnormalities 3 months of Lif Number of Infants with Brain Magnetic Resonance Imaging Abnormalities
neonatal behavioral neurological assessment 7,14 and 28 days after birth neonatal behavioral neurological assessment
Gross Motor Function Classification System 18 months of life Gross Motor Function Classification System
Trial Locations
- Locations (10)
Xiamen Maternity and Child Healthcare Hospital
🇨🇳Xiamen, Fujian, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Shenzhen Maternity and Child Healthcare Hospital
🇨🇳Shenzhen, Guangdong, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
The Maternity and Child Healthcare Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Guangxi, Guangxi, China
Hunan Children's hospital
🇨🇳Changsha, Hunan, China
The First Hospital of Jilin University
🇨🇳Jilin, Jilin, China
Chengdu Women and Children's central hospital
🇨🇳Chengdu, Sichuan, China
Xiamen Maternity and Child Healthcare Hospital🇨🇳Xiamen, Fujian, ChinaXingzhu LinContactxinzhufj@163.com