Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
Study NCT ID:
NCT00828295
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2009-01-22
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077924', 'term': 'Palonosetron'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'salvatore.chessari@helsinn.com', 'phone': '+41 91 985 21 21', 'title': 'Salvatore Chessari', 'organization': 'Helsinn Healthcare SA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the study, all adverse events were recorded and Patients stayed in the study for 22 days as a maximum. Duration of the safety follow up was 14 days after the patient completed the study for non Serious adverse events.', 'description': 'Serious AEs were followed up until resolution/or reached a stable condition/or until subject lost to follow-up, Safety Set/SAF included all randomized patients assigned to treatment group according to actual treatment received. SAF had 74 and 76 patients/1 mcg/kg 3 mcg/kg group respectively/since one patient randomized 1 mcg/kg was treated 3 mcg/kg', 'eventGroups': [{'id': 'EG000', 'title': '1 mcg/kg Arm', 'description': 'Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)\n\npalonosetron: palonosetron IV 1 mcg/kg', 'otherNumAtRisk': 74, 'otherNumAffected': 29, 'seriousNumAtRisk': 74, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '3 mcg/kg Arm', 'description': 'Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)\n\npalonosetron: palonosetron 3mcg/kg IV', 'otherNumAtRisk': 76, 'otherNumAffected': 32, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rhinalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 mcg/kg Arm', 'description': 'Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)\n\npalonosetron: palonosetron IV 1 mcg/kg'}, {'id': 'OG001', 'title': '3 mcg/kg Arm', 'description': 'Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)\n\npalonosetron: palonosetron 3mcg/kg IV'}], 'classes': [{'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '78.4', 'upperLimit': '94.4'}, {'value': '84.0', 'groupId': 'OG001', 'lowerLimit': '73.7', 'upperLimit': '91.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-72 hours post-operatively', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all randomized patients, who received the study drug, had general anesthesia and surgery. Following the intent-to-treat principle, patients were assigned to the study treatment group according to the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Complete Response 0-24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 mcg/kg Arm', 'description': 'Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)\n\npalonosetron: palonosetron IV 1 mcg/kg'}, {'id': 'OG001', 'title': '3 mcg/kg Arm', 'description': 'Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)\n\npalonosetron: palonosetron 3mcg/kg IV'}], 'classes': [{'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '78.4', 'upperLimit': '94.4'}, {'value': '84.0', 'groupId': 'OG001', 'lowerLimit': '73.7', 'upperLimit': '91.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-24 hours', 'description': 'Complete Response defined as no vomiting, no retching, and no use of rescue medication', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 mcg/kg Arm', 'description': 'Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)\n\npalonosetron: palonosetron IV 1 mcg/kg'}, {'id': 'FG001', 'title': '3 mcg/kg Arm', 'description': 'Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)\n\npalonosetron: palonosetron 3mcg/kg IV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First patient enrolled: 19 August 2008. Last patient completed: 27 December 2008.\n\nA total of 12 Investigators from two countries (Russia and Ukraine) participated in the study. The study was conducted at 4 sites in Russia and 8 sites in Ukraine.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1 mcg/kg Arm', 'description': 'Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)\n\npalonosetron: palonosetron IV 1 mcg/kg'}, {'id': 'BG001', 'title': '3 mcg/kg Arm', 'description': 'Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)\n\npalonosetron: palonosetron 3mcg/kg IV'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<2 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': '2 to <6 years', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': '6 to <12 years', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': '12 to <17 years', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Ukraine', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'dispFirstSubmitDate': '2010-04-15', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2009-01-22', 'dispFirstSubmitQcDate': '2010-04-15', 'resultsFirstSubmitDate': '2014-06-27', 'studyFirstSubmitQcDate': '2009-01-22', 'dispFirstPostDateStruct': {'date': '2010-04-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-28', 'studyFirstPostDateStruct': {'date': '2009-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively', 'timeFrame': '0-72 hours post-operatively'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients With Complete Response 0-24 Hours', 'timeFrame': '0-24 hours', 'description': 'Complete Response defined as no vomiting, no retching, and no use of rescue medication'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postoperative Nausea and Vomiting', 'palonosetron', 'pediatric'], 'conditions': ['Postoperative Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to assess the safety and efficacy of two doses of IV palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years inclusive undergoing surgical procedures requiring general endotracheal inhalation anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'MAIN INCLUSION CRITERIA\n\n* Male or female patient aged more than 28 days (full term) up to and including 16 years.\n* Inpatient scheduled to undergo surgical procedures requiring general endotracheal anesthesia, including:\n\n * ear, nose and throat surgery;\n * eye surgery;\n * orchidopexy;\n * plastic reconstructive surgery;\n * herniorraphy;\n * orthopedic surgery).\n* American Society of Anesthesiologists (ASA) physical status I, II or III.\n* Patient scheduled to receive nitrous oxide during the maintenance phase of anesthesia.\n* Patient scheduled to be hospitalized for at least 72 hours after wake up of surgery\n* For female of childbearing potential: the patient and her parent(s)/legal guardian(s) were counseled on the importance of not becoming pregnant before or during the study and the patient must have a negative pregnancy test at the pre-treatment visit and at the study treatment visit.\n\nMAIN EXCLUSION CRITERIA\n\n* For infant aged more than 12 months: a history of gastro-esophageal reflux.\n* For patient aged 28 days to 6 years: patient who received any investigational drugs within 90 days prior to Day 1. For patient aged 6 up to 16 years inclusive: patient who received any investigational drugs within 30 days prior to Day 1.\n* Patient scheduled to undergo emergency surgery.\n* Patient scheduled to receive regional (spinal) anesthesia in conjunction with general endotracheal anesthesia.\n* Patient scheduled to receive propofol during the maintenance phase of anesthesia.\n* Patient with vomiting from any organic cause.\n* Any drug with a potential anti-emetic effect within 24 hours prior to the administration of anesthesia.\n* Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia.'}, 'identificationModule': {'nctId': 'NCT00828295', 'briefTitle': 'Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Helsinn Healthcare SA'}, 'officialTitle': 'A Multicenter, Double-blind, Randomized, Parallel Group, Stratified Study to Assess the Safety and Efficacy of Single IV Doses of Palonosetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients', 'orgStudyIdInfo': {'id': 'PALO-07-29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 mcg/kg arm', 'description': 'Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)', 'interventionNames': ['Drug: palonosetron']}, {'type': 'EXPERIMENTAL', 'label': '3 mcg/kg arm', 'description': 'Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)', 'interventionNames': ['Drug: palonosetron']}], 'interventions': [{'name': 'palonosetron', 'type': 'DRUG', 'description': 'palonosetron IV 1 mcg/kg', 'armGroupLabels': ['1 mcg/kg arm']}, {'name': 'palonosetron', 'type': 'DRUG', 'description': 'palonosetron 3mcg/kg IV', 'armGroupLabels': ['3 mcg/kg arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State Institution Central Research Institute of Traumatology and Orthopedics n.a. N.N. Priorov under the Federal Agency for High-Tech Medical Care', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State Institution Moscow Research Institute of Pediatrics and Pediatric Surgery under the Federal Agency for High-Tech Medical Care', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Federal State Institution St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the Federal Agency for High-Tech Medical Care', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'State Higher Educational Institution: "St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Yaroslavl', 'country': 'Russia', 'facility': "State Healthcare Institution 'Regional Pediatric Clinical Hospital'", 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'city': 'Cherkassy', 'country': 'Ukraine', 'facility': 'Cherkassy Regional Hospital, Pediatric Surgery Department', 'geoPoint': {'lat': 49.44452, 'lon': 32.05738}}, {'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': "Regional Children's Clinical Hospital. Dnipropetrovsk State Medical Academy, Pediatric Surgery Department", 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'city': 'Donetsk', 'country': 'Ukraine', 'facility': "M.Gorkyi Donetsk National Medical University, Pediatric Surgery Department; Children's Regional Clinical Hospital", 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': "Regional Children's Hospital, ENT Department, Ivano-Frankivsk State Medical University, ENT Department", 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Specialized Children\'s Hospital "OKHMATDYT", Orthopedics and Traumatology Department, O.O. Bohomolets National Medical University, Pediatric Surgery Department', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Ukrainian Specialized Children\'s Hospital "OKHMATDYT", Anesthesiology and Intensive Care Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric Anesthesiology and Intensive Care Department', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Ukrainian Specialized Children\'s Hospital "OKHMATDYT", ENT Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric ENT Department', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Children\'s Clinical Hospital "OKHMATDYT", Institute of Congenital Pathology under the Academy of Medical Sciences of Ukraine', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinn Healthcare SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}