Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy

Study Overview
=================
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.

Official Title
-----------------
Effect of Hyperbaric Oxygen Therapy on Neonatal Hypoxic-Ischemic Encephalopathy

Conditions
-----------------
Hypoxic-ischemic Encephalopathy

Intervention / Treatment
-----------------
* Device: hyperbaric oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hyperbaric oxygen<br>Newborns with hypoxic ischemic encephalopathy treated with intensive care and hyperbaric oxygen | Device: hyperbaric oxygen<br>* 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.<br>|
| No Intervention: control<br>Newborns with hypoxic ischemic encephalopathy treated with intensive care only | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number 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 | 18 months of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities | Number of Infants with abnormal ambulatory electroencephalography monitoring | 3 months of life | 
| Number of Infants with Brain Magnetic Resonance Imaging Abnormalities | Number of Infants with Brain Magnetic Resonance Imaging Abnormalities | 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 | 3 months of life | 
| neonatal behavioral neurological assessment | neonatal behavioral neurological assessment | 7,14 and 28 days after birth | 
| Bayley Scales of Infant Development | Bayley Scales of Infant Development | 6,12 and 18 months of life | 
| Gross Motor Function Classification System | Gross Motor Function Classification System | 18 months of life | 
| Adverse Events That Are Related to Treatment | fundus examination by ophthalmofunduscope to evaluate retinopathy of prematurity，chest radiograph to evaluate pneumothorax, and monitoring vital signs by neonatal monitor | 3 months of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypoxic-ischemic encephalopathy, hyperbaric oxygen therapy