Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy
Primary Purpose
Hypoxic-ischemic Encephalopathy
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hyperbaric oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxic-ischemic Encephalopathy focused on measuring hypoxic-ischemic encephalopathy, hyperbaric oxygen therapy
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.
Sites / Locations
- Xiamen Maternity and Child Healthcare HospitalRecruiting
- Nanfang Hospital of Southern Medical UniversityRecruiting
- The Third Affiliated Hospital of Guangzhou Medical UniversityRecruiting
- Zhujiang Hospital of Southern Medical UniversityRecruiting
- Shenzhen Maternity and Child Healthcare Hospital
- Shenzhen People's HospitalRecruiting
- The Maternity and Child Healthcare Hospital of Guangxi Zhuang Autonomous Region
- Hunan Children's hospitalRecruiting
- The First Hospital of Jilin UniversityRecruiting
- Chengdu Women and Children's central hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
hyperbaric oxygen
control
Arm Description
Newborns with hypoxic ischemic encephalopathy treated with intensive care and hyperbaric oxygen
Newborns with hypoxic ischemic encephalopathy treated with intensive care only
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities
Number of Infants with abnormal ambulatory electroencephalography monitoring
Number of Infants with Brain Magnetic Resonance Imaging Abnormalities
Number of Infants with Brain Magnetic Resonance Imaging Abnormalities
Number of Infants with Brain-stem Auditory Evoked Potentials Abnormalities at 3 Months of Life
Number of Infants with Brain-stem Auditory Evoked Potentials
neonatal behavioral neurological assessment
neonatal behavioral neurological assessment
Bayley Scales of Infant Development
Bayley Scales of Infant Development
Gross Motor Function Classification System
Gross Motor Function Classification System
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
Full Information
NCT ID
NCT02894866
First Posted
August 26, 2016
Last Updated
April 3, 2018
Sponsor
Nanfang Hospital, Southern Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02894866
Brief Title
Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy
Official Title
Effect of Hyperbaric Oxygen Therapy on Neonatal Hypoxic-Ischemic Encephalopathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic-ischemic Encephalopathy
Keywords
hypoxic-ischemic encephalopathy, hyperbaric oxygen therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hyperbaric oxygen
Arm Type
Experimental
Arm Description
Newborns with hypoxic ischemic encephalopathy treated with intensive care and hyperbaric oxygen
Arm Title
control
Arm Type
No Intervention
Arm Description
Newborns with hypoxic ischemic encephalopathy treated with intensive care only
Intervention Type
Device
Intervention Name(s)
hyperbaric oxygen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Death or Moderate to Severe Disability Which is Graded According to Gross Motor Function Classification System (GMFCS)
Description
Number of Death or Moderate to Severe Disability Which is Graded According to
Time Frame
18 months of life
Secondary Outcome Measure Information:
Title
Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities
Description
Number of Infants with abnormal ambulatory electroencephalography monitoring
Time Frame
3 months of life
Title
Number of Infants with Brain Magnetic Resonance Imaging Abnormalities
Description
Number of Infants with Brain Magnetic Resonance Imaging Abnormalities
Time Frame
3 months of Lif
Title
Number of Infants with Brain-stem Auditory Evoked Potentials Abnormalities at 3 Months of Life
Description
Number of Infants with Brain-stem Auditory Evoked Potentials
Time Frame
3 months of life
Title
neonatal behavioral neurological assessment
Description
neonatal behavioral neurological assessment
Time Frame
7,14 and 28 days after birth
Title
Bayley Scales of Infant Development
Description
Bayley Scales of Infant Development
Time Frame
6,12 and 18 months of life
Title
Gross Motor Function Classification System
Description
Gross Motor Function Classification System
Time Frame
18 months of life
Title
Adverse Events That Are Related to Treatment
Description
fundus 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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lishan Guo, Doctor
Phone
+86 13580538496
Email
nfyygls@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Yang, Master
Phone
+86 18933930186
Email
ekym@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weimin Huang, Doctor
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Xiamen Maternity and Child Healthcare Hospital
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingzhu Lin
Email
xinzhufj@163.com
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lishan Guo, doctor
Phone
+86 13580538496
Email
nfyygls@163.com
Facility Name
The Third Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiliang Cui
Phone
+86 13922705830
Email
1551838354@qq.com
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Wang
Email
wangbin6556@126.com
Facility Name
Shenzhen Maternity and Child Healthcare Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuanzhong Yang
Phone
+86 13500051711
Email
13500051711@163.com
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benqing Wu
Phone
+86 13902436593
Email
wubenqing783@126.com
Facility Name
The Maternity and Child Healthcare Hospital of Guangxi Zhuang Autonomous Region
City
Guangxi
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiufen Wei
Phone
+86 18077166317
Email
Wqf915@126.com
Facility Name
Hunan Children's hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410007
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoming Peng
Email
pxmprf@163.com
Facility Name
The First Hospital of Jilin University
City
Jilin
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaoying Yan
Phone
+86 13756661611
Email
yanchaoying224@126.com
Facility Name
Chengdu Women and Children's central hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Ju
Phone
+86 18080103629
Email
Jurong123@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy
We'll reach out to this number within 24 hrs