Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-24 @ 8:26 AM
Study NCT ID:
NCT03962894
Status:
COMPLETED
Last Update Posted:
2025-05-08
First Post:
2019-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Administration of Steroids in the Ambulance Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jennifer.Fishe@jax.ufl.edu', 'phone': '904-244-4046', 'title': 'Jennifer Fishe', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': 'There were no serious AEs, no mortality, and no other non serious AEs observed in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Early Prehospital Systemic Corticosteroids', 'description': 'Children with asthma attacks who receive systemic corticosteroids and bronchodilators in the prehospital environment by emergency medical services', 'otherNumAtRisk': 175, 'deathsNumAtRisk': 175, 'otherNumAffected': 0, 'seriousNumAtRisk': 175, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Early Prehospital Systemic Corticosteroids', 'description': 'Children with asthma attacks treated by emergency medical services who receive bronchodilators en route to emergency departments, where in the ED they then receive systemic corticosteroids', 'otherNumAtRisk': 659, 'deathsNumAtRisk': 659, 'otherNumAffected': 0, 'seriousNumAtRisk': 659, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hospital Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Prehospital Systemic Corticosteroids', 'description': 'Children with asthma attacks who receive systemic corticosteroids and bronchodilators in the prehospital environment by emergency medical services'}, {'id': 'OG001', 'title': 'No Early Prehospital Systemic Corticosteroids', 'description': 'Children with asthma attacks treated by emergency medical services who receive bronchodilators en route to emergency departments, where in the ED they then receive systemic corticosteroids'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (ED stay)', 'description': 'Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Emergency Department Length-of-stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Prehospital Systemic Corticosteroids', 'description': 'Children with asthma attacks who receive systemic corticosteroids and bronchodilators in the prehospital environment by emergency medical services'}, {'id': 'OG001', 'title': 'No Early Prehospital Systemic Corticosteroids', 'description': 'Children with asthma attacks treated by emergency medical services who receive bronchodilators en route to emergency departments, where in the ED they then receive systemic corticosteroids'}], 'classes': [{'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000', 'lowerLimit': '127', 'upperLimit': '256'}, {'value': '159', 'groupId': 'OG001', 'lowerLimit': '108', 'upperLimit': '228'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (from EMS arrival to ED disposition)', 'description': 'Length of time in emergency department for patients from arrival to disposition (i.e., length of time for discharge, admission, or transfer to another hospital)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Houston EMS Pre and Post-Protocol Change', 'description': 'Children with asthma attacks treated by Houston EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 10/1/2014.'}, {'id': 'FG001', 'title': 'Cincinnati EMS Pre- and Post-Protocol Change', 'description': 'Children with asthma attacks treated by Cincinnati EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 1/1/2016.'}, {'id': 'FG002', 'title': 'Nassau County FL EMS Pre- and Post- Protocol Change', 'description': 'Children with asthma attacks treated by Nassau County FL EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 6/1/2019.'}, {'id': 'FG003', 'title': 'Lee County FL EMS Pre- and Post- Protocol Change', 'description': 'Children with asthma attacks treated by Lee County FL EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 11/1/2019.'}, {'id': 'FG004', 'title': 'Walton County FL EMS Pre- and Post-Protocol Change', 'description': 'Children with asthma attacks treated by Walton County FL EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 11/1/2020.'}, {'id': 'FG005', 'title': 'Leon County FL EMS Pre- and Post-Protocol Change', 'description': 'Children with asthma attacks treated by Leon County FL EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 2/1/2021.'}, {'id': 'FG006', 'title': 'Sarasota County FL EMS Pre- and Post-Protocol Change', 'description': 'Children with asthma attacks treated by Sarasota County FL EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 6/1/2021/'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Data was abstracted for 12 months after each EMS agency adopted a protocol incorporating oral systemic corticosteroids in addition to IV systemic corticosteroids.', 'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '265'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '271'}, {'groupId': 'FG002', 'numUnits': '1', 'numSubjects': '6'}, {'groupId': 'FG003', 'numUnits': '1', 'numSubjects': '133'}, {'groupId': 'FG004', 'numUnits': '1', 'numSubjects': '14'}, {'groupId': 'FG005', 'numUnits': '1', 'numSubjects': '99'}, {'groupId': 'FG006', 'numUnits': '1', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Data was abstracted for 12 months after each EMS agency adopted a protocol incorporating oral systemic corticosteroids in addition to IV systemic corticosteroids.', 'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '265'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '271'}, {'groupId': 'FG002', 'numUnits': '1', 'numSubjects': '6'}, {'groupId': 'FG003', 'numUnits': '1', 'numSubjects': '133'}, {'groupId': 'FG004', 'numUnits': '1', 'numSubjects': '14'}, {'groupId': 'FG005', 'numUnits': '1', 'numSubjects': '99'}, {'groupId': 'FG006', 'numUnits': '1', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'EMS agencies', 'recruitmentDetails': 'There was no recruitment, as this was an observational study of patients who were receiving EMS treatment regardless of the study.', 'preAssignmentDetails': 'EMS agencies who decided to incorporate oral systemic corticosteroids as part of clinical care were for this study. The study assigned the start date for EMS agencies to include oral systemic corticosteroids. For the purpose of analysis, we treated that as a stepped wedge protocol design. All agencies contributed one year of data for early prehospital systemic corticosteroids, and one year of data for no prehospital systemic corticosteroids.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'BG000'}, {'value': '659', 'groupId': 'BG001'}, {'value': '834', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Early Prehospital Systemic Corticosteroids', 'description': 'Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services\n\nPrednisolone: During a sequenced rollout protocol change for several EMS agencies, those agencies will adopt protocol change to administer prednisolone to children with asthma attacks in the prehospital environment prior to ED arrival.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Children with asthma attacks treated by emergency medical services who receive usual care en route to emergency departments, where in the ED they then receive systemic corticosteroids'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '13'}, {'value': '8', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '12'}, {'value': '8', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '381', 'groupId': 'BG001'}, {'value': '448', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '278', 'groupId': 'BG001'}, {'value': '386', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', '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': '107', 'groupId': 'BG000'}, {'value': '417', 'groupId': 'BG001'}, {'value': '524', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '183', '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': '29', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Bronchodilator Administered', 'classes': [{'categories': [{'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '688', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Bronchodilators included albuterol and xopenex, administered either via inhaler or nebulizer', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-09', 'size': 277807, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-07T10:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 834}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2019-05-22', 'resultsFirstSubmitDate': '2024-08-07', 'studyFirstSubmitQcDate': '2019-05-22', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-02', 'studyFirstPostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Admission', 'timeFrame': 'Day 1 (ED stay)', 'description': 'Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation'}], 'secondaryOutcomes': [{'measure': 'Emergency Department Length-of-stay', 'timeFrame': 'Day 1 (from EMS arrival to ED disposition)', 'description': 'Length of time in emergency department for patients from arrival to disposition (i.e., length of time for discharge, admission, or transfer to another hospital)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma in Children']}, 'descriptionModule': {'briefSummary': "Asthma is the most common chronic disease of childhood and is a leading cause of emergency medical treatment. For children experiencing an asthma exacerbation, emergency department (ED) guidelines recommend early systemic corticosteroid (CS) administration, since studies have shown associated, time-sensitive, decreases in hospital admissions and ED length-of-stay (LOS). For patients who are treated by 911 emergency medical services (EMS) first, there exists an opportunity for even earlier administration of CS, prior to ED arrival. Yet, preliminary data demonstrate that currently less than 10% of EMS pediatric asthma patients receive CS prior to ED arrival.\n\nGiven the known time-sensitivity of CS' effects on patient outcomes, the investigators hypothesize that even earlier EMS administration of CS will decrease hospital admissions, ED LOS, and intensive care unit admissions for pediatric patients with an acute asthma exacerbation. Using a pragmatic observation design in multiple EMS agencies, we will enroll patients to analyze clinical outcomes and comparative costs of EMS CS administration, and how both are influenced by EMS transport time. That novel combination of analyses will help build evidence-based guidelines adaptable for diverse EMS agencies nationwide."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary problem: Asthma exacerbation\n* stable to take an oral medication\n* transported by EMS to an ED\n\nExclusion Criteria:\n\n* unconscious, hemodynamically unstable, or critically ill -\\> EMS will proceed with usual critical care (includes IV methylprednisolone as per protocol)\n* daily or every other day corticosteroid therapy\n* allergy to prednisolone or another corticosteroid\n* chronic lung disease besides asthma, airway anatomic abnormalities, tracheostomy, immunocompromised, traumatic injury, pregnancy, law enforcement custody, non-English speaking'}, 'identificationModule': {'nctId': 'NCT03962894', 'acronym': 'EASI-AS-ODT', 'briefTitle': 'Early Administration of Steroids in the Ambulance Setting', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Early Administration of Steroids in the Ambulance Setting: An Observational Design Trial', 'orgStudyIdInfo': {'id': 'IRB201901351 -N-A'}, 'secondaryIdInfos': [{'id': '1K23HL149991-01', 'link': 'https://reporter.nih.gov/quickSearch/1K23HL149991-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Prehospital Systemic Corticosteroids', 'description': 'Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services', 'interventionNames': ['Drug: Prednisolone']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Children with asthma attacks treated by emergency medical services who receive usual care en route to emergency departments, where in the ED they then receive systemic corticosteroids'}], 'interventions': [{'name': 'Prednisolone', 'type': 'DRUG', 'description': 'During a sequenced rollout protocol change for several EMS agencies, those agencies will adopt protocol change to administer prednisolone to children with asthma attacks in the prehospital environment prior to ED arrival.', 'armGroupLabels': ['Early Prehospital Systemic Corticosteroids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32433', 'city': 'DeFuniak Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Walton County EMS', 'geoPoint': {'lat': 30.72102, 'lon': -86.11522}}, {'zip': '33905', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Lee County Public Safety & Emergency Services', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '34236', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota County EMS', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '32301', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Leon County EMS', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '32097', 'city': 'Yulee', 'state': 'Florida', 'country': 'United States', 'facility': 'Nassau County Fire Rescue Department', 'geoPoint': {'lat': 30.6319, 'lon': -81.60649}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital / UT Houston", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jennifer Fishe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}