Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
Study NCT ID:
NCT03488303
Status:
COMPLETED
Last Update Posted:
2019-05-21
First Post:
2018-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impedance Pneumography Measurement During Acute Airway Obstruction and Recovery Phase in Young Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-20', 'studyFirstSubmitDate': '2018-03-28', 'studyFirstSubmitQcDate': '2018-03-28', 'lastUpdatePostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between clinical status and tidal breathing flow-volume (TBFV) curves', 'timeFrame': '2-4 nights while at ward', 'description': 'Assess the association between clinical status and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System'}], 'secondaryOutcomes': [{'measure': 'Association between lung function and tidal breathing flow-volume (TBFV) curves', 'timeFrame': '2-4 nights while at ward and 2 + 2 nights after discharge from hospital', 'description': 'Assess the association between lung function (spirometry or oscillometry) and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System'}, {'measure': 'Association between asthma control and tidal breathing flow-volume (TBFV) curves', 'timeFrame': '2 + 2 nights after discharge from hospital', 'description': 'Assess the association between asthma control (C-ACT questionnaire) and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstruction; Airway, With Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® LFTS in infants and preschoolers during acute airway obstruction/asthma exacerbation and recovery thereof for changes in the IP-derived TBFV curves within and between nights.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young children admitted to the ward at the hospital due to acute lower airway obstruction/asthma exacerbation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 1-7\n* Diagnosis of acute airway obstruction or asthma exacerbation requiring inpatient treatment\n\nExclusion Criteria:\n\n* Need for an ICU treatment\n* Bronchiolitis\n* Pneumonia (not including viral infections)\n* Other cardiorespiratory or neurological chronic diseases or states that may significantly alter the overnight breathing pattern\n* Implanted or external active medical devices'}, 'identificationModule': {'nctId': 'NCT03488303', 'briefTitle': 'Impedance Pneumography Measurement During Acute Airway Obstruction and Recovery Phase in Young Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Revenio Research'}, 'officialTitle': 'Impedance Pneumography Measurement During Acute Airway Obstruction and Recovery Phase in Young Children', 'orgStudyIdInfo': {'id': 'VCS-006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Main group', 'description': 'Study has only one group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': "Children's Hospital Srebrnjak", 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}], 'overallOfficials': [{'name': 'Davor Plavec, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Srebrnjak"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Revenio Research', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Children's Hospital Srebrnjak", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}