Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-04-15 @ 3:39 AM
Study NCT ID:
NCT01862250
Status:
COMPLETED
Last Update Posted:
2018-01-05
First Post:
2013-04-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D003000', 'term': 'Clonidine'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'estelle.gauda@sickkids.ca', 'phone': '416-813-4908', 'title': 'Estelle B. Gauda', 'organization': 'University of Toronto'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Clonidine Infants With HIE', 'description': "Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming\n\nClonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.\n\nIf the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.\n\n* 10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration\n* 20% drop in HR from the infant's baseline, sustained for ≥30 min after administration\n* HR ≤70/min, sustained for ≥30 min after administration", 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Steady State Clonidine Blood Levels During Hypothermia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine Infants With HIE', 'description': "Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming\n\nClonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.\n\nIf the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.\n\n* 10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration\n* 20% drop in HR from the infant's baseline, sustained for ≥30 min after administration\n* HR ≤70/min, sustained for ≥30 min after administration"}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.27', 'upperLimit': '1.06'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 days', 'description': 'Trough clonidine blood levels were measured after 4-7 doses of clonidine were given intravenously with a dosing interval of every 8 hrs. Mean and standard deviation (SD) of the number of doses given prior to levels being drawn was 5.3 (mean) and 0.37 (SD).\n\nTime after last dose before measurement was 9hrs (mean) and 2.7hrs (SD).', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 8 babies were assessed for this outcome because the rest did not have a steady state trough level performed during cooling'}, {'type': 'PRIMARY', 'title': 'Amount of Morphine Given', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine Infants With HIE', 'description': "Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming\n\nClonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.\n\nIf the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.\n\n* 10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration\n* 20% drop in HR from the infant's baseline, sustained for ≥30 min after administration\n* HR ≤70/min, sustained for ≥30 min after administration"}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 days', 'description': 'Intravenous morphine (mg/kg) was given. The standard dose is 0.05 mg/kg per dose', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Presence of Shivering After Clonidine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine Infants With HIE', 'description': "Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming\n\nClonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.\n\nIf the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.\n\n* 10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration\n* 20% drop in HR from the infant's baseline, sustained for ≥30 min after administration\n* HR ≤70/min, sustained for ≥30 min after administration"}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48hrs', 'description': 'Babies were assessed after administration of clonidine for the presence or absence of shivering.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Passive Rewarming', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clonidine Infants With HIE', 'description': "Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming\n\nClonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.\n\nIf the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.\n\n* 10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration\n* 20% drop in HR from the infant's baseline, sustained for ≥30 min after administration\n* HR ≤70/min, sustained for ≥30 min after administration"}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '10.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Beginning at 72 hours up to 12 hours', 'description': 'Following 2 hours of therapeutic hypothermia, the temperature of the thermo-blanket is adjusted up half degree per hour allowing passive rewarming until 36.5 degrees is reached', 'unitOfMeasure': 'Hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clonidine Infants With HIE', 'description': "Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming\n\nClonidine (Duraclon®): Clonidine at dosing intervals of 6, 8, 12, 18 or 24 hours.\n\nIf the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.\n\n* 10 mm Hg reduction in Mean Arterial Pressure (MAP) or MAP ≤ 40 mm Hg sustained for ≥30 min after administration\n* 20% drop in Heart Rate (HR) from the infant's baseline, sustained for ≥30 min after administration\n* HR ≤70/min, sustained for ≥30 min after administration"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'Study medication was not administered for one participant'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Clonidine Infants With HIE', 'description': "Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming\n\nClonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.\n\nIf the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.\n\n* 10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration\n* 20% drop in HR from the infant's baseline, sustained for ≥30 min after administration\n* HR ≤70/min, sustained for ≥30 min after administration"}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.2', 'groupId': 'BG000', 'lowerLimit': '35.9', 'upperLimit': '39.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2015-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-04', 'studyFirstSubmitDate': '2013-04-01', 'resultsFirstSubmitDate': '2017-10-19', 'studyFirstSubmitQcDate': '2013-05-23', 'lastUpdatePostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-04', 'studyFirstPostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Steady State Clonidine Blood Levels During Hypothermia', 'timeFrame': '3 days', 'description': 'Trough clonidine blood levels were measured after 4-7 doses of clonidine were given intravenously with a dosing interval of every 8 hrs. Mean and standard deviation (SD) of the number of doses given prior to levels being drawn was 5.3 (mean) and 0.37 (SD).\n\nTime after last dose before measurement was 9hrs (mean) and 2.7hrs (SD).'}, {'measure': 'Amount of Morphine Given', 'timeFrame': 'Up to 2 days', 'description': 'Intravenous morphine (mg/kg) was given. The standard dose is 0.05 mg/kg per dose'}], 'secondaryOutcomes': [{'measure': 'Presence of Shivering After Clonidine', 'timeFrame': '48hrs', 'description': 'Babies were assessed after administration of clonidine for the presence or absence of shivering.'}, {'measure': 'Time to Passive Rewarming', 'timeFrame': 'Beginning at 72 hours up to 12 hours', 'description': 'Following 2 hours of therapeutic hypothermia, the temperature of the thermo-blanket is adjusted up half degree per hour allowing passive rewarming until 36.5 degrees is reached'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Encephalopathy, Hypoxic-Ischemic']}, 'referencesModule': {'references': [{'pmid': '19398463', 'type': 'BACKGROUND', 'citation': 'Agthe AG, Kim GR, Mathias KB, Hendrix CW, Chavez-Valdez R, Jansson L, Lewis TR, Yaster M, Gauda EB. Clonidine as an adjunct therapy to opioids for neonatal abstinence syndrome: a randomized, controlled trial. Pediatrics. 2009 May;123(5):e849-56. doi: 10.1542/peds.2008-0978. Epub 2009 Apr 27.'}, {'pmid': '15774841', 'type': 'BACKGROUND', 'citation': 'Angeles DM, Wycliffe N, Michelson D, Holshouser BA, Deming DD, Pearce WJ, Sowers LC, Ashwal S. Use of opioids in asphyxiated term neonates: effects on neuroimaging and clinical outcome. Pediatr Res. 2005 Jun;57(6):873-8. doi: 10.1203/01.PDR.0000157676.45088.8C. Epub 2005 Mar 17.'}, {'pmid': '18381513', 'type': 'BACKGROUND', 'citation': 'Roka A, Melinda KT, Vasarhelyi B, Machay T, Azzopardi D, Szabo M. Elevated morphine concentrations in neonates treated with morphine and prolonged hypothermia for hypoxic ischemic encephalopathy. Pediatrics. 2008 Apr;121(4):e844-9. doi: 10.1542/peds.2007-1987.'}, {'pmid': '15099676', 'type': 'BACKGROUND', 'citation': 'Zhang Y. Clonidine preconditioning decreases infarct size and improves neurological outcome from transient forebrain ischemia in the rat. Neuroscience. 2004;125(3):625-31. doi: 10.1016/j.neuroscience.2004.02.011.'}, {'pmid': '16221780', 'type': 'BACKGROUND', 'citation': 'Shankaran S, Laptook AR, Ehrenkranz RA, Tyson JE, McDonald SA, Donovan EF, Fanaroff AA, Poole WK, Wright LL, Higgins RD, Finer NN, Carlo WA, Duara S, Oh W, Cotten CM, Stevenson DK, Stoll BJ, Lemons JA, Guillet R, Jobe AH; National Institute of Child Health and Human Development Neonatal Research Network. Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy. N Engl J Med. 2005 Oct 13;353(15):1574-84. doi: 10.1056/NEJMcps050929.'}]}, 'descriptionModule': {'briefSummary': 'This research is being done to find out the safety of the investigational study drug, Clonidine Hydrochloride ( CLON). , in infants who are undergoing whole body cooling for the treatment of hypoxic ischemic encephalopathy (HIE). The only known and effective treatment for HIE is therapeutic hypothermia or whole body cooling for72 hours. During the cooling process, babies get agitated, shiver and are uncomfortable. To treat these side effects morphine is frequently used. CLON is very effective in decreasing shivering in adults and children. Furthermore, in some preclinical studies, clonidine has been shown to be neuroprotective (safe for the brain in models of brain injury)..This is a Phase I-II to determine if low dose CLON will reduce the incidence of shivering and whether it has short term cardiovascular safety. In this Phase I-II study, the investigators will determine the (i) the maximum tolerated dose of CLON during cooling for HIE, (ii) the effects of CLON on heart rate, blood pressure, core body temperature and cerebral autoregulation (ability to maintain constant blood flow to the brain) and (iii) association between blood levels and changes in the above parameters. In this study the investigators hope to find ways to improve sedation, shivering and agitation in newborn infants with HIE on the cooling protocol. Our ultimate goal is determine the potential neuro-protective properties of clonidine in newborn babies with HIE.', 'detailedDescription': "The most desirable sedative-analgesic agent used in infants with HIE would 1) have an excellent safety profile, 2) provide adequate analgesia and sedation, 3) reduce shivering, 4) cause minimal respiratory depression, 5) preserve cerebrovascular autoregulation, and 6) confer neuroprotection. Several lines of evidence suggest alpha 2 adrenergic receptor agonist class of sedatives-analgesics may have all these properties. The investigators have recently developed a sensitive assay to measure clonidine levels which will allow us to perform population Pharmacokinetic (PK)/Pharmacodynamic (PD) analyses of clonidine in sick newborns. Thus, this phase I/II trial is designed to test the hypothesis clonidine , an alpha- 2 adrenergic receptor agonist, will reduce the incidence of shivering without adversely affecting heart rate (HR), blood pressure (BP), temperature regulation or cerebrovascular autoregulation.\n\nEssentially all classes of sedative-analgesic agents affect mean arterial blood pressure (MAP) which can alter cerebral perfusion and affect cerebrovascular autoregulation. Cerebrovascular autoregulation is when blood flow to the brain is held relatively constant over a wide range of MAPs; it ensures a steady supply of oxygenated blood to the brain, and is only functional within a specific range of MAP's. When MAP deviates from this range and drops below the lower limit of autoregulation, blood flow becomes passive to MAP and the brain is placed at risk for ischemic injury. Brain injury alters cerebrovascular autoregulation in the region of injury, and together with sub-optimal MAP after hypoxic brain injury could cause more brain ischemia leading to poor outcomes, seizures, and permanent neurologic injuries. Little information is available on the effect of HIE alone or in combination with hypothermia on cerebrovascular autoregulation, and no information is published on the direct effect of sedative-analgesics on alterations in hemodynamic parameters and subsequent indirect or direct effects on cerebrovascular autoregulation in newborns with HIE. Thus, this study will establish the safety of clonidine, a commonly used sedative-analgesic in infants and children, in a population of infants with HIE undergoing therapeutic hypothermia. A secondary exploratory outcome is to determine the efficacy of clonidine in reducing shivering during the cooling phase of the therapeutic hypothermia protocol."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'minimumAge': '35 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants ≥35 0/7 weeks gestation with the diagnosis of HIE who are being treated with therapeutic hypothermia, who have indwelling arterial lines\n* Informed parental consent\n\nExclusion Criteria:\n\n* Infants who are considered moribund and the clinical team is considering withdrawal of support\n* Infants who need \\> 20 µg/kg/min of dopamine or the addition of epinephrine or dobutamine to maintain a mean arterial pressure (MAP) ≥ 45 mmHg, or milrinone for cardiovascular support\n* Baseline heart rate (HR) \\<80 bpm during hypothermia\n* Infants suspected of major chromosomal anomalies, except trisomy 21\n* Infants with major cardiovascular anomalies\n* Infants with severe persistent pulmonary hypertension of the newborn who are enrolled and who then need Extracorporal Membrane Oxygenation (ECMO) will be withdrawn from the study'}, 'identificationModule': {'nctId': 'NCT01862250', 'acronym': 'HIE', 'briefTitle': 'Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia', 'nctIdAliases': ['NCT02252848'], 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Phase I-II Clinical Trial to Determine the Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia', 'orgStudyIdInfo': {'id': 'ID: NA_00072308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clonidine infants with HIE', 'description': 'Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming', 'interventionNames': ['Drug: Clonidine (Duraclon®)']}], 'interventions': [{'name': 'Clonidine (Duraclon®)', 'type': 'DRUG', 'description': "Clonidine at dosing intervals of 6, 8, 12, 18 or 24 hours. If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.\n\n* 10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration\n* 20% drop in HR from the infant's baseline, sustained for ≥30 min after administration\n* HR ≤70/min, sustained for ≥30 min after administration", 'armGroupLabels': ['Clonidine infants with HIE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Estelle B Gauda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Maryland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}