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..
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
The hyperbaric oxygen treatment will be administered for 60 min in a baby hyperbaric oxygen chamber pressured with 100% oxygen to 1.5 to 1.8 atm absolute (ATA) and a constant oxygen flow was given to maintain the oxygen. concentration in the chamber at 80% or greater.The treatment will be administered once a day within 7 days after birth, 7 days is a course of treatment, at least for 4 courses.
Xiamen Maternity and Child Healthcare Hospital
Xiamen, Fujian, China
RECRUITINGNanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGNumber of Death or Moderate to Severe Disability Which is Graded According to Gross Motor Function Classification System (GMFCS)
Number of Death or Moderate to Severe Disability Which is Graded According to
Time frame: 18 months of life
Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities
Number of Infants with abnormal ambulatory electroencephalography monitoring
Time frame: 3 months of life
Number of Infants with Brain Magnetic Resonance Imaging Abnormalities
Number of Infants with Brain Magnetic Resonance Imaging Abnormalities
Time frame: 3 months of Lif
Number of Infants with Brain-stem Auditory Evoked Potentials Abnormalities at 3 Months of Life
Number of Infants with Brain-stem Auditory Evoked Potentials
Time frame: 3 months of life
neonatal behavioral neurological assessment
neonatal behavioral neurological assessment
Time frame: 7,14 and 28 days after birth
Bayley Scales of Infant Development
Bayley Scales of Infant Development
Time frame: 6,12 and 18 months of life
Gross Motor Function Classification System
Gross Motor Function Classification System
Time frame: 18 months of life
Adverse Events That Are Related to Treatment
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The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGZhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGShenzhen Maternity and Child Healthcare Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGShenzhen People's Hospital
Shenzhen, Guangdong, China
RECRUITINGThe Maternity and Child Healthcare Hospital of Guangxi Zhuang Autonomous Region
Guangxi, Guangxi, China
NOT_YET_RECRUITINGHunan Children's hospital
Changsha, Hunan, China
RECRUITINGThe First Hospital of Jilin University
Jilin City, Jilin, China
RECRUITINGChengdu Women and Children's central hospital
Chengdu, Sichuan, China
RECRUITINGfundus examination by ophthalmofunduscope to evaluate retinopathy of prematurity,chest radiograph to evaluate pneumothorax, and monitoring vital signs by neonatal monitor
Time frame: 3 months of life