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Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02894866
Recruitment Status : Recruiting
First Posted : September 9, 2016
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of 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..

Condition or disease Intervention/treatment Phase
Hypoxic-ischemic Encephalopathy Device: hyperbaric oxygen Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Hyperbaric Oxygen Therapy on Neonatal Hypoxic-Ischemic Encephalopathy
Study Start Date : October 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: hyperbaric oxygen
Newborns with hypoxic ischemic encephalopathy treated with intensive care and hyperbaric oxygen
Device: 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.

No Intervention: control
Newborns with hypoxic ischemic encephalopathy treated with intensive care only



Primary Outcome Measures :
  1. Number of Death or Moderate to Severe Disability Which is Graded According to Gross Motor Function Classification System (GMFCS) [ Time Frame: 18 months of life ]
    Number of Death or Moderate to Severe Disability Which is Graded According to


Secondary Outcome Measures :
  1. Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities [ Time Frame: 3 months of life ]
    Number of Infants with abnormal ambulatory electroencephalography monitoring

  2. Number of Infants with Brain Magnetic Resonance Imaging Abnormalities [ Time Frame: 3 months of Lif ]
    Number of Infants with Brain Magnetic Resonance Imaging Abnormalities

  3. Number of Infants with Brain-stem Auditory Evoked Potentials Abnormalities at 3 Months of Life [ Time Frame: 3 months of life ]
    Number of Infants with Brain-stem Auditory Evoked Potentials

  4. neonatal behavioral neurological assessment [ Time Frame: 7,14 and 28 days after birth ]
    neonatal behavioral neurological assessment

  5. Bayley Scales of Infant Development [ Time Frame: 6,12 and 18 months of life ]
    Bayley Scales of Infant Development

  6. Gross Motor Function Classification System [ Time Frame: 18 months of life ]
    Gross Motor Function Classification System

  7. Adverse Events That Are Related to Treatment [ Time Frame: 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



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894866


Contacts
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Contact: Lishan Guo, Doctor +86 13580538496 nfyygls@163.com
Contact: Ming Yang, Master +86 18933930186 ekym@vip.sina.com

Locations
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China, Fujian
Xiamen Maternity and Child Healthcare Hospital Recruiting
Xiamen, Fujian, China, 361003
Contact: Xingzhu Lin       xinzhufj@163.com   
China, Guangdong
Nanfang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Lishan Guo, doctor    +86 13580538496    nfyygls@163.com   
The Third Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Qiliang Cui    +86 13922705830    1551838354@qq.com   
Zhujiang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510280
Contact: Bin Wang       wangbin6556@126.com   
Shenzhen Maternity and Child Healthcare Hospital Not yet recruiting
Shenzhen, Guangdong, China, 518000
Contact: Chuanzhong Yang    +86 13500051711    13500051711@163.com   
Shenzhen People's Hospital Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Benqing Wu    +86 13902436593    wubenqing783@126.com   
China, Guangxi
The Maternity and Child Healthcare Hospital of Guangxi Zhuang Autonomous Region Not yet recruiting
Guangxi, Guangxi, China, 530000
Contact: Qiufen Wei    +86 18077166317    Wqf915@126.com   
China, Hunan
Hunan Children's hospital Recruiting
Changsha, Hunan, China, 410007
Contact: Xiaoming Peng       pxmprf@163.com   
China, Jilin
The First Hospital of Jilin University Recruiting
Jilin, Jilin, China, 130000
Contact: Chaoying Yan    +86 13756661611    yanchaoying224@126.com   
China, Sichuan
Chengdu Women and Children's central hospital Recruiting
Chengdu, Sichuan, China, 610000
Contact: Rong Ju    +86 18080103629    Jurong123@126.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
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Study Chair: Weimin Huang, Doctor Nanfang Hospital of Southern Medical University

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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02894866    
Other Study ID Numbers: NFEC-2016-097
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nanfang Hospital of Southern Medical University:
hypoxic-ischemic encephalopathy
hyperbaric oxygen therapy
Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Ischemia
Hypoxia
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain