Hypoxic-ischemic EncephalopathyNCT02894866
Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy
A study testing hyperbaric oxygen in people with Hypoxic-ischemic Encephalopathy, run by Nanfang Hospital, Southern Medical University at 10 sites in China.
Trial 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.. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Hypoxic-ischemic Encephalopathy
- What is being tested?
- hyperbaric oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 10 sitesChina
- Study dates
- Oct 2016to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Hunan Children's hospital
Changsha, Hunan, 410007
Xiaoming Peng, pxmprf@163.com
- Recruiting
Chengdu Women and Children's central hospital
Chengdu, Sichuan, 610000
Rong Ju, +86 18080103629, Jurong123@126.com
- Not yet recruiting
The Maternity and Child Healthcare Hospital of Guangxi Zhuang Autonomous Region
Guangxi, Guangxi, 530000
Qiufen Wei, +86 18077166317, Wqf915@126.com
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
Lishan Guo, doctor, +86 13580538496, nfyygls@163.com
- Recruiting
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Qiliang Cui, +86 13922705830, 1551838354@qq.com
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Bin Wang, wangbin6556@126.com
- Recruiting
The First Hospital of Jilin University
Jilin City, Jilin, 130000
Chaoying Yan, +86 13756661611, yanchaoying224@126.com
- Not yet recruiting
Shenzhen Maternity and Child Healthcare Hospital
Shenzhen, Guangdong, 518000
Chuanzhong Yang, +86 13500051711, 13500051711@163.com
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518000
Benqing Wu, +86 13902436593, wubenqing783@126.com
- Recruiting
Xiamen Maternity and Child Healthcare Hospital
Xiamen, Fujian, 361003
Xingzhu Lin, xinzhufj@163.com
About this study
Official title: 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..
Read the 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.
- Conditions
- Hypoxic-ischemic Encephalopathy
- Being tested
- hyperbaric oxygen
- Keywords
- hypoxic-ischemic encephalopathy, hyperbaric oxygen therapy
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric oxygenDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| hyperbaric oxygen | Experimental | Newborns with hypoxic ischemic encephalopathy treated with intensive care and hyperbaric oxygen Receives: Device: hyperbaric oxygen |
| control | No intervention | Newborns with hypoxic ischemic encephalopathy treated with intensive care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months of life
Secondary outcomes (7)
Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities
Number of Infants with abnormal ambulatory electroencephalography monitoring
Measured: 3 months of life
Number of Infants with Brain Magnetic Resonance Imaging Abnormalities
Number of Infants with Brain Magnetic Resonance Imaging Abnormalities
Measured: 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
Measured: 3 months of life
neonatal behavioral neurological assessment
neonatal behavioral neurological assessment
Measured: 7,14 and 28 days after birth
Bayley Scales of Infant Development
Bayley Scales of Infant Development
Measured: 6,12 and 18 months of life
Gross Motor Function Classification System
Gross Motor Function Classification System
Measured: 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
Measured: 3 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-ischemic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weimin Huang, Doctor, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894866
- Sponsor's protocol ID
- NFEC-2016-097
- Status last verified
- Mar 2018
- First submitted
- 26 Aug 2016
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyperbaric Oxygen Therapy on Neonatal Hypoxic-Ischemic Encephalopathy
- ClinicalTrials.gov ID
- NCT02894866
- Acronym / sponsor ID
- NFEC-2016-097
- Conditions
- Hypoxic-ischemic Encephalopathy
- Keywords
- hypoxic-ischemic encephalopathy, hyperbaric oxygen therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperbaric oxygen | Experimental | Device: hyperbaric oxygenNewborns with hypoxic ischemic encephalopathy treated with intensive care and hyperbaric oxygen |
| control | No intervention | –Newborns with hypoxic ischemic encephalopathy treated with intensive care only |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperbaric oxygenThe 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. | Device | hyperbaric oxygen |
Primary outcome
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
7 secondary outcomes
Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities
Time frame: 3 months of life
Number of Infants with Brain Magnetic Resonance Imaging Abnormalities
Time frame: 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
neonatal behavioral neurological assessment
Time frame: 7,14 and 28 days after birth
Bayley Scales of Infant Development
Time frame: 6,12 and 18 months of life
Gross Motor Function Classification System
Time frame: 18 months of life
Adverse Events That Are Related to Treatment
Time frame: 3 months of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: No
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Hypoxic-Ischemic Encephalopathy
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Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
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Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
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Neuro-MoD: Neuroplasticity With Motor Development
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weimin Huang, Doctor study chair
Nanfang Hospital, Southern Medical University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperbaric oxygen in people with Hypoxic-ischemic Encephalopathy, run by Nanfang Hospital, Southern Medical University at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lishan Guo, Doctor (+86 13580538496, nfyygls@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.