Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-29 @ 9:19 AM
Study NCT ID:
NCT05909566
Status:
RECRUITING
Last Update Posted:
2025-07-11
First Post:
2023-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Support and Treatment for Efficient and Cost-Effective Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001988', 'term': 'Bronchiolitis'}], 'ancestors': [{'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'We will be providing clinical decision support tools for children receiving HHFNC for bronchiolitis, testing the impact of decision support compared to usual care in a pragmatic randomized trial. All subjects will receive standard of care.\n\nDecisions regarding management will be at the discretion of the treating provider and will not be restricted or altered in any way.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2023-05-24', 'studyFirstSubmitQcDate': '2023-06-11', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HFNC duration', 'timeFrame': 'Timeframe consists of a start time of either randomization or the last documentation of positive pressure ventilation (whichever is later) and the last documentation of HFNC in the electronic flowsheet, up to 30 days', 'description': 'Amount of time patient is on HFNC'}], 'secondaryOutcomes': [{'measure': 'Respiratory support free days', 'timeFrame': 'From date the start of respiratory support until the first documented respiratory support free day, up to 30 days', 'description': 'Days alive and free of intensive care unit-based respiratory'}, {'measure': 'Hospital length of stay', 'timeFrame': 'From date of admission until discharge or date of death from any cause, whichever came first, assessed up to 90 days.', 'description': 'Days admitted in hospital'}, {'measure': 'Organ support free days', 'timeFrame': 'From date of admission until the first day of ICU-based respiratory or cardiovascular organ support or discharge or date of death from any case, whichever came first, assessed up to 30 days', 'description': 'Days alive and free of ICU-based respiratory or cardiovascular organ support'}, {'measure': 'Time to oral intake', 'timeFrame': 'From date of ending HHFNC until first documented oral intake, assessed up to 30 days', 'description': 'Time from HHFNC and oral intake'}, {'measure': 'Ostensible respiratory distress measured by a respiratory severity score', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'The product of mean airway pressure and the fraction of inspired oxygen'}, {'measure': 'Cost of hospitalization', 'timeFrame': 'Days from admission to discharge from hospital or date of death, up to 90 days. Of note, an earlier outcome was listed for 90-day cost of care and the redundancy with this outcome was recognized, so the 90-day cost of care outcome was removed.', 'description': 'Totality of expenses incurred by a hospital in providing its services and care'}, {'measure': 'Mortality', 'timeFrame': 'From date of admission until death from any cause, assessed up to 90 days', 'description': 'Patient Death'}, {'measure': 'PICU length of stay', 'timeFrame': 'From data of admission to PICU to discharge from the PICU or death from any cause, whichever came first, assessed up to 90 days.', 'description': 'Days admitted in the PICU. This is added to reconcile the plan to evaluate this outcome and its noted absence from this website, as pointed out by a reviewer while working to publish the trial design.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Bronchiolitis']}, 'referencesModule': {'references': [{'pmid': '39014495', 'type': 'DERIVED', 'citation': "Horvat CM, Suresh S, James N, Aneja RK, Au AK, Berry S, Blumer A, Bricker K, Clark RSB, Dolinich H, Hahner S, Jockel C, Kalivoda J, Loar I, Marasco D, Marcinick A, Marroquin O, O'brien J, Pelletier J, Ramgopal S, Venkataraman S, Angus DC, Butler G. A randomized, embedded, pragmatic, Bayesian clinical trial examining clinical decision support for high flow nasal cannula management in children with bronchiolitis: design and statistical analysis plan. Trials. 2024 Jul 16;25(1):484. doi: 10.1186/s13063-024-08327-y."}]}, 'descriptionModule': {'briefSummary': "This project aims to answer the essential questions about the management of acute, pediatric respiratory illness, accelerate recovery from these all-too-common diseases, curb unnecessary costs of care, and demonstrate UPMC Children's Hospital of Pittsburgh's capabilities as the premier, world-class leader in the arena of pediatric learning healthcare systems. REST EEC will focus on the question of whether clinical decision support (CDS) facilitates the standardization of the initiation and weaning of heated high flow nasal cannula (HHFNC) for bronchiolitis.REST EEC will focus on whether the application of CDS improves adherence to a standardized guideline and leads to improved patient-centered outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<2 years of age Bronchiolitis WOB Score \\>2\n\nExclusion Criteria:\n\n* Immunocompromised\n* Immunosuppressed\n* Chronic lung disease\n* Congenital heart disease with baseline cardiorespiratory manifestations'}, 'identificationModule': {'nctId': 'NCT05909566', 'acronym': 'REST EEC', 'briefTitle': 'Respiratory Support and Treatment for Efficient and Cost-Effective Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Respiratory Support and Treatment for Efficient and Cost-Effective Care', 'orgStudyIdInfo': {'id': 'STUDY23010030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HHFNC + Clinical decision Support', 'description': 'Standardized HHFNC weaning coupled with clinical decision support consisting of electronic record embedded reminders to the clinical team to wean HHFNC', 'interventionNames': ['Other: Clinical Decision Support (CDS)', 'Device: HHFNC Weaning']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HHFNC Weaning', 'description': 'Team does not receive clinical decision support reminders to wean the HHFNC', 'interventionNames': ['Other: Clinical Decision Support (CDS)', 'Device: HHFNC Weaning']}], 'interventions': [{'name': 'Clinical Decision Support (CDS)', 'type': 'OTHER', 'description': 'Education to front line clinicians and staff on standardized implementation and weaning of HHFNC and standardized assessments of patient work of breathing. HHFNC implementation and weaning strategies will be based on age-specific practices recommended by the American Academy of Pediatrics. Education will be undertaken by dedicated clinical educators.', 'armGroupLabels': ['HHFNC + Clinical decision Support', 'HHFNC Weaning']}, {'name': 'HHFNC Weaning', 'type': 'DEVICE', 'description': 'Wean patient off oxygen and flow as oxygenation and work of breathing improves.', 'armGroupLabels': ['HHFNC + Clinical decision Support', 'HHFNC Weaning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Horvat, MD', 'role': 'CONTACT', 'email': 'christopher.horvat@chp.edu', 'phone': '4126925298'}], 'facility': "UPMC Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Christopher Horvat, MD', 'role': 'CONTACT', 'email': 'christopher.horvat@chp.edu', 'phone': '4126925298'}, {'name': 'India Loar', 'role': 'CONTACT', 'email': 'idl1@pitt.edu', 'phone': '4126480613'}], 'overallOfficials': [{'name': 'Christopher Horvat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "UPMC Children's Hospital of Pittsburgh"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christopher Horvat', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beckwith Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Christopher Horvat', 'investigatorAffiliation': 'University of Pittsburgh'}}}}