Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy
NCT ID: NCT02894866
Last Updated: 2018-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2016-10-31
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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hyperbaric oxygen
Newborns with hypoxic ischemic encephalopathy treated with intensive care and hyperbaric oxygen
hyperbaric oxygen
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.
control
Newborns with hypoxic ischemic encephalopathy treated with intensive care only
No interventions assigned to this group
Interventions
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hyperbaric oxygen
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* During the acute phases of intracranial and (or) fundus hemorrhage. o
* Intracranial infection.
* Pneumothorax.
* Infants who have been received hypothermia.
7 Days
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Principal Investigators
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Weimin Huang, Doctor
Role: STUDY_CHAIR
Nanfang Hospital, Southern Medical University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NFEC-2016-097
Identifier Type: -
Identifier Source: org_study_id
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