Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-23 @ 4:32 AM
Study NCT ID:
NCT02071394
Status:
COMPLETED
Last Update Posted:
2023-01-05
First Post:
2014-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020925', 'term': 'Hypoxia-Ischemia, Brain'}, {'id': 'D007035', 'term': 'Hypothermia'}], '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'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054020', 'term': 'Lasers, Gas'}, {'id': 'D007036', 'term': 'Hypothermia, Induced'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}, {'id': 'D017679', 'term': 'Cryotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-18', 'size': 4334179, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-06T11:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2014-02-21', 'studyFirstSubmitQcDate': '2014-02-24', 'lastUpdatePostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of normal infants', 'timeFrame': '18-24 months', 'description': 'Bayley III composite score ≥ 85 and no neurosensory disability as described above'}], 'primaryOutcomes': [{'measure': 'Death and moderate or severe disability - Bayley III neurodevelopmental outcome score', 'timeFrame': '18 months of age', 'description': 'Cognition, language and motor scores, hearing and vision'}], 'secondaryOutcomes': [{'measure': 'Brain MRI', 'timeFrame': 'Before hospital discharge, within 2 weeks of birth', 'description': 'Magnetic Resonance Imaging findings at less than 2 weeks of age'}, {'measure': 'Amplitude Integrated Electroencephalogram (aEEG) grading', 'timeFrame': 'Before hospital discharge, usually within 1 week of birth', 'description': 'Number of hours after birth when aEEG voltage has reached a normal or discontinuous normal pattern'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Xenon', 'Hypothermia', 'Hypoxic Ischemic Encephalopathy', 'Newborn', 'Neonate', 'Term', 'Neuroprotection', 'Cooling', 'HIE'], 'conditions': ['Hypoxic Ischaemic Encephalopathy']}, 'referencesModule': {'references': [{'pmid': '19608817', 'type': 'BACKGROUND', 'citation': 'Chakkarapani E, Thoresen M, Hobbs CE, Aquilina K, Liu X, Dingley J. A closed-circuit neonatal xenon delivery system: a technical and practical neuroprotection feasibility study in newborn pigs. Anesth Analg. 2009 Aug;109(2):451-60. doi: 10.1213/ane.0b013e3181aa9550.'}, {'pmid': '18309163', 'type': 'BACKGROUND', 'citation': 'Hobbs C, Thoresen M, Tucker A, Aquilina K, Chakkarapani E, Dingley J. Xenon and hypothermia combine additively, offering long-term functional and histopathologic neuroprotection after neonatal hypoxia/ischemia. Stroke. 2008 Apr;39(4):1307-13. doi: 10.1161/STROKEAHA.107.499822. Epub 2008 Feb 28.'}, {'pmid': '19142190', 'type': 'BACKGROUND', 'citation': 'Thoresen M, Hobbs CE, Wood T, Chakkarapani E, Dingley J. Cooling combined with immediate or delayed xenon inhalation provides equivalent long-term neuroprotection after neonatal hypoxia-ischemia. J Cereb Blood Flow Metab. 2009 Apr;29(4):707-14. doi: 10.1038/jcbfm.2008.163. Epub 2009 Jan 14.'}, {'pmid': '20658563', 'type': 'BACKGROUND', 'citation': 'Chakkarapani E, Dingley J, Liu X, Hoque N, Aquilina K, Porter H, Thoresen M. Xenon enhances hypothermic neuroprotection in asphyxiated newborn pigs. Ann Neurol. 2010 Sep;68(3):330-41. doi: 10.1002/ana.22016.'}, {'pmid': '22160201', 'type': 'BACKGROUND', 'citation': 'Chakkarapani E, Thoresen M, Liu X, Walloe L, Dingley J. Xenon offers stable haemodynamics independent of induced hypothermia after hypoxia-ischaemia in newborn pigs. Intensive Care Med. 2012 Feb;38(2):316-23. doi: 10.1007/s00134-011-2442-7. Epub 2011 Dec 13.'}, {'pmid': '24777219', 'type': 'BACKGROUND', 'citation': 'Dingley J, Tooley J, Liu X, Scull-Brown E, Elstad M, Chakkarapani E, Sabir H, Thoresen M. Xenon ventilation during therapeutic hypothermia in neonatal encephalopathy: a feasibility study. Pediatrics. 2014 May;133(5):809-18. doi: 10.1542/peds.2013-0787.'}, {'pmid': '25794112', 'type': 'BACKGROUND', 'citation': 'Dingley J, Liu X, Gill H, Smit E, Sabir H, Tooley J, Chakkarapani E, Windsor D, Thoresen M. The feasibility of using a portable xenon delivery device to permit earlier xenon ventilation with therapeutic cooling of neonates during ambulance retrieval. Anesth Analg. 2015 Jun;120(6):1331-6. doi: 10.1213/ANE.0000000000000693.'}]}, 'descriptionModule': {'briefSummary': 'This study examines the effect of inhaled xenon gas in the treatment of newborn infants with hypoxic-ischemic encephalopathy (HIE) in combination with cooling, which is the standard treatment for this condition. The hypothesis is that the xenon + cooling combination will produce better neuroprotection than the standard treatment of cooling alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Infants will be eligible for for the trial if the St Michael's hospital standard inclusion criteria for cooling and additional inclusion criteria for xenon administration are met.\n\nSt Michael's hospital standard inclusion criteria for standard hypothermia treatment of 72 hrs:\n\nA: Neonates born at greater than 36 weeks gestation (estimated or clinical assessment) with at least ONE of the following:\n\n1. Apgar score of ≤5 at ten minutes after birth\n2. Continued need for resuscitation, including tracheal or mask ventilation, at ten minutes after birth\n3. Acidosis, defined as either umbilical cord pH or any arterial, venous or capillary pH within 60 minutes of birth less \\< 7.00\n4. Base deficit ≥16 mmol/L in umbilical cord blood sample or any blood sample within 60 minutes of birth (arterial or venous blood).\n\nIf the infant meets criterion A then assess for neurological abnormality using criterion B and C (by trained personnel):\n\nB: Moderate or Severe encephalopathy as evidenced by any of the following:\n\n1. Altered state of consciousness (reduced or absent responses or pathological irritability and hyper responsive and at least ONE or more of the following:\n2. Hypotonia\n3. Abnormal reflexes including oculomotor or pupillary abnormalities\n4. Absent or weak suck\n5. Clinical seizures, as recorded by trained personnel\n\nAnd\n\nC: At least 30 minutes duration of amplitude-integrated electroencephalography (aEEG) recording that shows abnormal background aEEG activity. The decision to cool is based on the worst 30 min section of the aEEG, not the best \\[35\\] or seizures (clinical or electrical) thus meeting ONE of the following:\n\n1. Normal background with some (\\> 5 min) electrical seizure activity\n2. Moderately abnormal activity (upper margin of trace \\>10μV and lower margin \\<5μV)\n3. Suppressed activity (upper margin of trace \\<10μV and lower margin of trace \\<5μV)\n4. Definite seizure activity\n\nAdditional inclusion criteria for xenon:\n\nBefore being considered for additional inhaled xenon therapy via the breathing gas mixture, the infant would need to meet further additional entry criteria (all must be met):\n\n1. Intubated, ventilated, sedated, being cooled\n2. ≤ 5 hours old\n3. Any seizures under control\n4. Weight \\> 2nd centile for gestational age\n5. Stable cardiovascular parameters; Mean arterial pressure \\>40mmHg.\n6. Oxygen requirement via mechanical ventilator ≤ 40%.\n7. Positive End Expiratory Pressure (PEEP) requirement ≤ 8cm H2O\n8. Arterial (preferable)/capillary/venous pCO2 within acceptable range (\\<7kPa)\n9. Postnatal age ≤ 5 hours\n10. Absence of major congenital abnormalities, imperforate anus and in particular any bowel obstruction, congenital abnormalities suggestive of chromosomal anomaly or other syndromes that include brain dysgenesis. Congenital syndromes affecting the brain should be excluded when diagnosed.\n\nExclusion criteria for cooling in the CoolXenon3 study:\n\n1. Infants expected to be greater than 3 hours of age at the time of starting cooling treatment.\n2. Futility. Where prognosis is considered to be hopeless e.g. no cardiac output for 20 minutes."}, 'identificationModule': {'nctId': 'NCT02071394', 'acronym': 'CoolXenon3', 'briefTitle': 'Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Bristol and Weston NHS Foundation Trust'}, 'officialTitle': 'Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth: A Randomised Pilot Outcomes Study (COOLXENON3 Study)', 'orgStudyIdInfo': {'id': 'CH/2013/4414'}, 'secondaryIdInfos': [{'id': '2013-004478-80', 'type': 'EUDRACT_NUMBER'}, {'id': '13/SW/0300', 'type': 'OTHER', 'domain': 'NRES Committee South West'}, {'id': 'CI/2013/0050', 'type': 'OTHER', 'domain': 'MHRA Devices'}, {'id': '12893/0235/001-0001', 'type': 'OTHER', 'domain': 'MHRA Medicines'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '72h cooling + 18h xenon inhalation', 'description': 'Babies in poor condition at birth and referred to our neonatal unit for standard therapy of cooling to 33.5 degree C body temperature will be randomised to receive xenon gas at 50% concentration for 18 hours', 'interventionNames': ['Drug: Xenon gas', 'Other: Whole body cooling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard 72 h whole body cooling therapy', 'description': 'Whole body cooling therapy to rectal temperature of 33.5 degree Centigrade (standard therapy)', 'interventionNames': ['Other: Whole body cooling']}], 'interventions': [{'name': 'Xenon gas', 'type': 'DRUG', 'otherNames': ['LENOXe'], 'description': 'Inhalation via endotracheal tube of 50% xenon for 18 hours, including during transport for outborn babies, starting within 5 hours after birth.', 'armGroupLabels': ['72h cooling + 18h xenon inhalation']}, {'name': 'Whole body cooling', 'type': 'OTHER', 'otherNames': ['Therapeutic hypothermia'], 'description': 'Cooling of baby to reduce rectal temperature to 33.5 degree Centigrade(standard treatment), including during transport for outborn babies, starting within 3 hours after birth.', 'armGroupLabels': ['72h cooling + 18h xenon inhalation', 'Standard 72 h whole body cooling therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BS2 8EG', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': "St Michael's Hospital", 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College / Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Marianne Thoresen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bristol'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Bristol and Weston NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bristol', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}