Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy

April 3, 2018 updated by: Nanfang Hospital of Southern Medical University

Effect of Hyperbaric Oxygen Therapy on Neonatal Hypoxic-Ischemic Encephalopathy

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..

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • Xiamen Maternity and Child Healthcare Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510280
        • Recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The Third Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • Shenzhen People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518000
        • Not yet recruiting
        • Shenzhen Maternity and Child Healthcare Hospital
        • Contact:
    • Guangxi
      • Guangxi, Guangxi, China, 530000
        • Not yet recruiting
        • The Maternity and Child Healthcare Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410007
        • Recruiting
        • Hunan Children's Hospital
        • Contact:
    • Jilin
      • Jilin, Jilin, China, 130000
        • Recruiting
        • The first hospital of Jilin University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Chengdu Women and Children's Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

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）
Time Frame: 18 months of life
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
Time Frame: 3 months of life
Number of Infants with abnormal ambulatory electroencephalography monitoring
3 months of life
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 months of Lif
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
3 months of life
neonatal behavioral neurological assessment
Time Frame: 7,14 and 28 days after birth
neonatal behavioral neurological assessment
7,14 and 28 days after birth
Bayley Scales of Infant Development
Time Frame: 6,12 and 18 months of life
Bayley Scales of Infant Development
6,12 and 18 months of life
Gross Motor Function Classification System
Time Frame: 18 months of life
Gross Motor Function Classification System
18 months of life
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
3 months of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Study Chair: Weimin Huang, Doctor, Nanfang Hospital of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

September 4, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2016-097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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