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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..
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hyperbaric oxygen | Experimental | Newborns with hypoxic ischemic encephalopathy treated with intensive care and hyperbaric oxygen |
|
| control | No Intervention | Newborns with hypoxic ischemic encephalopathy treated with intensive care only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyperbaric oxygen | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 18 months of life |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities | Number of Infants with abnormal ambulatory electroencephalography monitoring | 3 months of life |
| Number of Infants with Brain Magnetic Resonance Imaging Abnormalities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lishan Guo, Doctor | Contact | +86 13580538496 | nfyygls@163.com | |
| Ming Yang, Master | Contact | +86 18933930186 | ekym@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Weimin Huang, Doctor | Nanfang Hospital, Southern Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiamen Maternity and Child Healthcare Hospital | Recruiting | Xiamen | Fujian | 361003 | China |
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| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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|
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 | Number of Infants with Brain-stem Auditory Evoked Potentials | 3 months of life |
| neonatal behavioral neurological assessment | neonatal behavioral neurological assessment | 7,14 and 28 days after birth |
| Bayley Scales of Infant Development | Bayley Scales of Infant Development | 6,12 and 18 months of life |
| Gross Motor Function Classification System | Gross Motor Function Classification System | 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 | 3 months of life |
| Nanfang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510000 | China |
|
| The Third Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510000 | China |
|
| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510280 | China |
|
| Shenzhen Maternity and Child Healthcare Hospital | Not yet recruiting | Shenzhen | Guangdong | 518000 | China |
|
| Shenzhen People's Hospital | Recruiting | Shenzhen | Guangdong | 518000 | China |
|
| The Maternity and Child Healthcare Hospital of Guangxi Zhuang Autonomous Region | Not yet recruiting | Guangxi | Guangxi | 530000 | China |
|
| Hunan Children's hospital | Recruiting | Changsha | Hunan | 410007 | China |
|
| The First Hospital of Jilin University | Recruiting | Jilin City | Jilin | 130000 | China |
|
| Chengdu Women and Children's central hospital | Recruiting | Chengdu | Sichuan | 610000 | China |
|
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |