Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-04-16 @ 8:29 AM
Study NCT ID:
NCT02774850
Status:
COMPLETED
Last Update Posted:
2019-12-23
First Post:
2016-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Home Away From Home - Medical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aplenc@email.chop.edu', 'phone': '267-426-7252', 'title': 'Dr. Richard Aplenc', 'organization': "Children's Hospital of Philadelphia"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were not monitored while chart abstractions began in December 2015 and were completed in July 2019. As this is an observational study, it was determined that adverse events were a non-issue.', 'description': 'There is no study intervention; this is a medical record abstraction study only, thus adverse events were not monitored or assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Early Discharge Management', 'description': 'Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Inpatient Management', 'description': 'Remain hospitalized during chemotherapy-induced neutropenia', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Occurrence of Post-chemotherapy Bacteremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Discharge Management', 'description': 'Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course'}, {'id': 'OG001', 'title': 'Inpatient Management', 'description': 'Remain hospitalized during chemotherapy-induced neutropenia'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC > 200 uL), or until the start of the next course.', 'description': 'Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC \\> 200 uL), or until the start of the next course (for a very small number of patients who begin the next course of chemotherapy prior to count recovery). Bacteremia will be defined as a single positive blood culture for a bacterial pathogen (including Viridans group Streptococci). If the bacterium is an organism considered as a common commensal organism by the National Healthcare Safety Network, two separate positive blood cultures will be required for classification as bacteremia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in study course Induction II analyzed for bacteremia for this course.'}, {'type': 'SECONDARY', 'title': 'Time to the Initiation of the Next Chemotherapy Course', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Discharge Management', 'description': 'Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course'}, {'id': 'OG001', 'title': 'Inpatient Management', 'description': 'Remain hospitalized during chemotherapy-induced neutropenia'}], 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '27.8', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The number of days from the three days after the completion chemotherapy in a given course until the first day of the next course', 'description': 'Time to next course of chemotherapy will be measured as the number of days from the three days after the completion chemotherapy in a given course until the first day of the next course.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in Induction II who were analyzed for the amount of time (in days) it took for them to start their next chemotherapy course.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pediatric AML Patients', 'description': 'All patients included in chart abstractions. Exclusion criteria were applied to these patients to determine if they were early discharge eligible. Then they were assigned to outpatient-managed and inpatient-managed arms.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '610'}]}, {'type': 'Induction I', 'comment': 'Patients whose Induction I course was included in chart abstractions.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '585'}]}, {'type': 'Early Discharge Eligible at Induction I', 'comment': 'Study population after early discharge criteria were applied at Induction I.', 'achievements': [{'comment': '24 of these patients were managed as outpatients. 252 were managed as inpatients.', 'groupId': 'FG000', 'numSubjects': '276'}]}, {'type': 'Induction II', 'comment': 'Patients whose Induction II course was included in chart abstractions.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '564'}]}, {'type': 'Early Discharge Eligible at Induction II', 'comment': 'Study population after early discharge criteria were applied at Induction II.', 'achievements': [{'comment': '114 of these patients were managed as outpatients. 379 were managed as inpatients.', 'groupId': 'FG000', 'numSubjects': '493'}]}, {'type': 'Intensification I', 'comment': 'Patients whose Intensification I course was included in chart abstractions.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '476'}]}, {'type': 'Early Discharge Eligible at Int I', 'comment': 'Study population after early discharge criteria were applied at Intensification I.', 'achievements': [{'comment': '104 of these patients were managed as outpatients. 270 were managed as inpatients.', 'groupId': 'FG000', 'numSubjects': '374'}]}, {'type': 'Intensification II', 'comment': 'Patients whose Intensification II course was included in chart abstractions.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '342'}]}, {'type': 'Early Discharge Eligible at Int II', 'comment': 'Study population after early discharge criteria were applied at Intensification II.', 'achievements': [{'comment': '56 of these patients were managed as outpatients. 229 were managed as inpatients.', 'groupId': 'FG000', 'numSubjects': '285'}]}, {'type': 'Intensification III', 'comment': 'Patients whose Intensification III course was included in chart abstractions.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'Early Discharge Eligible at Int III', 'comment': 'Study population after early discharge criteria were applied at Intensification III.', 'achievements': [{'comment': '7 of these patients were managed as outpatients. 37 were managed as inpatients.', 'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'comment': 'This milestone reflects the total early discharge-eligible study population in the overall study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '575'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}]}], 'preAssignmentDetails': '610 patients reflects the total number of patients included in chart abstractions; from there exclusion criteria were applied to determine early discharge eligibility. They were assigned to Early Discharge Management and Inpatient Management by chemotherapy course, not by the overall treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '379', 'groupId': 'BG001'}, {'value': '493', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Early Discharge Management', 'description': 'Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course'}, {'id': 'BG001', 'title': 'Inpatient Management', 'description': 'Remain hospitalized during chemotherapy-induced neutropenia'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '379', 'groupId': 'BG001'}, {'value': '493', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Not recorded in EMR', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic Ethnicity', 'categories': [{'title': 'Hispanic Ethnicity', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic Ethnicity', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '302', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '379', 'groupId': 'BG001'}, {'value': '493', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'These were the discharge eligible patients who either remained inpatient or were managed outpatient during study course Induction II.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-02', 'size': 1024439, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-27T11:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 610}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-02', 'studyFirstSubmitDate': '2016-05-13', 'resultsFirstSubmitDate': '2019-09-04', 'studyFirstSubmitQcDate': '2016-05-16', 'lastUpdatePostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-02', 'studyFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Post-chemotherapy Bacteremia', 'timeFrame': 'Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC > 200 uL), or until the start of the next course.', 'description': 'Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC \\> 200 uL), or until the start of the next course (for a very small number of patients who begin the next course of chemotherapy prior to count recovery). Bacteremia will be defined as a single positive blood culture for a bacterial pathogen (including Viridans group Streptococci). If the bacterium is an organism considered as a common commensal organism by the National Healthcare Safety Network, two separate positive blood cultures will be required for classification as bacteremia.'}], 'secondaryOutcomes': [{'measure': 'Time to the Initiation of the Next Chemotherapy Course', 'timeFrame': 'The number of days from the three days after the completion chemotherapy in a given course until the first day of the next course', 'description': 'Time to next course of chemotherapy will be measured as the number of days from the three days after the completion chemotherapy in a given course until the first day of the next course.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pediatric', 'Neutropenia Management', 'Acute Myeloid Leukemia', 'Chart Abstraction', 'Chemotherapy'], 'conditions': ['Acute Myeloid Leukemia', 'Neutropenia', 'Bacteremia']}, 'descriptionModule': {'briefSummary': 'Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens that result in periods of profound neutropenia leaving patients susceptible to severe infectious complications. Infectious complications are the leading cause of treatment related mortality among AML patients, but there are little clinical data to inform whether management of neutropenia post AML chemotherapy should occur in an outpatient or inpatient setting. The primary objective of this study is to compare the clinical effectiveness of outpatient versus inpatient management of neutropenia in children with AML.', 'detailedDescription': 'This is a bidirectional observational cohort study.\n\nParticipants will be patients less that 19 years of age at diagnosis receiving or having received chemotherapy for AML from seventeen participating pediatric hospitals across the United States. There is no study intervention; this is a medical record abstraction study only. Investigators will abstract subjects medical record data over the study period in order to study clinical outcomes including the occurrence of bacteremia and time to the start of the next course in the chemotherapy regimen, in relation to neutropenia management strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population will include all AML patients who received or will receive chemotherapy between January 1, 2012 and December 31, 2019 at any of the fifteen participating pediatric institutions across the US. Patients discharged within 3 days after completion of that chemotherapy course will be categorized as 'early discharge' to outpatient management during neutropenia. Patients meeting eligibility criteria for 'early discharge' but remaining in the hospital more than 3 days after completion of that chemotherapy course will be categorized as inpatient management. Patients will be considered early discharge-eligible if there is no evidence of fever, infection or intensive care unit (ICU) level care within ± 3 days of the last dose of chemotherapy.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females of age less than 19 at diagnosis.\n2. Receipt or planned receipt of AML chemotherapy between January 1, 2012 and December 31, 2019.\n\nExclusion Criteria:\n\n1. Patients being treated for relapsed AML\n2. Patients with Acute Promyelocytic Leukemia (APML)\n3. Patients undergoing stem cell transplant (SCT)\n4. Patients receiving reduced intensity frontline chemotherapy'}, 'identificationModule': {'nctId': 'NCT02774850', 'acronym': 'Aim 1', 'briefTitle': 'Home Away From Home - Medical Outcomes', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Home or Away From Home: Comparing Clinical Outcomes Relevant to the Care of Pediatric Acute Myeloid Leukemia During Periods of Neutropenia', 'orgStudyIdInfo': {'id': '15-012074'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early Discharge Management', 'description': 'Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course'}, {'label': 'Inpatient Management', 'description': 'Remain hospitalized during chemotherapy-induced neutropenia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital of Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred I DuPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H Lurie Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Dana-Farber Cancer Institute/Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "C.S. Mott Children's Hospital", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center of Dallas", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Richard Aplenc, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Coded, limited data sets will be shared with participating sites upon approved request. Only aggregate level data will be shared with the study sponsor Patient-Centered Outcomes Research Institute (PCORI).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': "C.S. Mott Children's Hospital", 'class': 'OTHER'}, {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}, {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, {'name': "Children's Medical Center Dallas", 'class': 'OTHER'}, {'name': "Children's Hospital of Michigan", 'class': 'OTHER'}, {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'University of Mississippi Medical Center', 'class': 'OTHER'}, {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, {'name': 'Ochsner Health System', 'class': 'OTHER'}, {'name': "Lucile Packard Children's Hospital", 'class': 'OTHER'}, {'name': "Primary Children's Hospital", 'class': 'OTHER'}, {'name': "Rady Children's Hospital, San Diego", 'class': 'OTHER'}, {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, {'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}, {'name': "Children's Hospital Colorado", 'class': 'OTHER'}, {'name': 'Alfred I. duPont Hospital for Children', 'class': 'OTHER'}, {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}