Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-02-27 @ 3:13 AM
Study NCT ID:
NCT02894866
Status:
UNKNOWN
Last Update Posted:
2018-04-05
First Post:
2016-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020925', 'term': 'Hypoxia-Ischemia, Brain'}], 'ancestors': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002534', 'term': 'Hypoxia, Brain'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2016-08-26', 'studyFirstSubmitQcDate': '2016-09-04', 'lastUpdatePostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Death or Moderate to Severe Disability Which is Graded According to Gross Motor Function Classification System （GMFCS）', 'timeFrame': '18 months of life', 'description': 'Number of Death or Moderate to Severe Disability Which is Graded According to'}], 'secondaryOutcomes': [{'measure': 'Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities', 'timeFrame': '3 months of life', 'description': 'Number of Infants with abnormal ambulatory electroencephalography monitoring'}, {'measure': 'Number of Infants with Brain Magnetic Resonance Imaging Abnormalities', 'timeFrame': '3 months of Lif', 'description': 'Number of Infants with Brain Magnetic Resonance Imaging Abnormalities'}, {'measure': 'Number of Infants with Brain-stem Auditory Evoked Potentials Abnormalities at 3 Months of Life', 'timeFrame': '3 months of life', 'description': 'Number of Infants with Brain-stem Auditory Evoked Potentials'}, {'measure': 'neonatal behavioral neurological assessment', 'timeFrame': '7,14 and 28 days after birth', 'description': 'neonatal behavioral neurological assessment'}, {'measure': 'Bayley Scales of Infant Development', 'timeFrame': '6,12 and 18 months of life', 'description': 'Bayley Scales of Infant Development'}, {'measure': 'Gross Motor Function Classification System', 'timeFrame': '18 months of life', 'description': 'Gross Motor Function Classification System'}, {'measure': 'Adverse Events That Are Related to Treatment', 'timeFrame': '3 months of life', 'description': 'fundus examination by ophthalmofunduscope to evaluate retinopathy of prematurity，chest radiograph to evaluate pneumothorax, and monitoring vital signs by neonatal monitor'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypoxic-ischemic encephalopathy', 'hyperbaric oxygen therapy'], 'conditions': ['Hypoxic-ischemic Encephalopathy']}, 'descriptionModule': {'briefSummary': '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..', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "* Inclusion Criteria:\n\n * Newborn infants whose gestational age ≥37 weeks' gestation, weighing over 2500 g ;\n * Acute perinatal event (e.g., late or variable decelerations, cord prolapse, cord rupture, uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest)\n * 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.\n * 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\n* Exclusion Criteria:\n\n * A congenital and the hereditary disease, a chromosome abnormalities, and a congenital abnormality.\n * During the acute phases of intracranial and (or) fundus hemorrhage. o\n * Intracranial infection.\n * Pneumothorax.\n * Infants who have been received hypothermia."}, 'identificationModule': {'nctId': 'NCT02894866', 'briefTitle': 'Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Effect of Hyperbaric Oxygen Therapy on Neonatal Hypoxic-Ischemic Encephalopathy', 'orgStudyIdInfo': {'id': 'NFEC-2016-097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hyperbaric oxygen', 'description': 'Newborns with hypoxic ischemic encephalopathy treated with intensive care and hyperbaric oxygen', 'interventionNames': ['Device: hyperbaric oxygen']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Newborns with hypoxic ischemic encephalopathy treated with intensive care only'}], 'interventions': [{'name': 'hyperbaric oxygen', 'type': 'DEVICE', '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.', 'armGroupLabels': ['hyperbaric oxygen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361003', 'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingzhu Lin', 'role': 'CONTACT', 'email': 'xinzhufj@163.com'}], 'facility': 'Xiamen Maternity and Child Healthcare Hospital', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lishan Guo, doctor', 'role': 'CONTACT', 'email': 'nfyygls@163.com', 'phone': '+86 13580538496'}], 'facility': 'Nanfang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiliang Cui', 'role': 'CONTACT', 'email': '1551838354@qq.com', 'phone': '+86 13922705830'}], 'facility': 'The Third Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510280', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Wang', 'role': 'CONTACT', 'email': 'wangbin6556@126.com'}], 'facility': 'Zhujiang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '518000', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chuanzhong Yang', 'role': 'CONTACT', 'email': '13500051711@163.com', 'phone': '+86 13500051711'}], 'facility': 'Shenzhen Maternity and Child Healthcare Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '518000', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Benqing Wu', 'role': 'CONTACT', 'email': 'wubenqing783@126.com', 'phone': '+86 13902436593'}], 'facility': "Shenzhen People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '530000', 'city': 'Guangxi', 'state': 'Guangxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiufen Wei', 'role': 'CONTACT', 'email': 'Wqf915@126.com', 'phone': '+86 18077166317'}], 'facility': 'The Maternity and Child Healthcare Hospital of Guangxi Zhuang Autonomous Region'}, {'zip': '410007', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoming Peng', 'role': 'CONTACT', 'email': 'pxmprf@163.com'}], 'facility': "Hunan Children's hospital", 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '130000', 'city': 'Jilin', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chaoying Yan', 'role': 'CONTACT', 'email': 'yanchaoying224@126.com', 'phone': '+86 13756661611'}], 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.84652, 'lon': 126.5608}}, {'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rong Ju', 'role': 'CONTACT', 'email': 'Jurong123@126.com', 'phone': '+86 18080103629'}], 'facility': "Chengdu Women and Children's central hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Lishan Guo, Doctor', 'role': 'CONTACT', 'email': 'nfyygls@163.com', 'phone': '+86 13580538496'}, {'name': 'Ming Yang, Master', 'role': 'CONTACT', 'email': 'ekym@vip.sina.com', 'phone': '+86 18933930186'}], 'overallOfficials': [{'name': 'Weimin Huang, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}