Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-26 @ 3:15 AM
Study NCT ID:
NCT03529994
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2018-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Work of Breathing and Oxygen Saturation in Infants Receiving High Flow Nasal Cannula (HFNC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-27', 'studyFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2018-05-08', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Work of breathing indices', 'timeFrame': '2 hours', 'description': 'Altering HFNC flow rates and its effect on work of breathing indices in preterm infants with respiratory insufficiency.'}], 'secondaryOutcomes': [{'measure': 'Intermittent hypoxia', 'timeFrame': '2 hours', 'description': 'Altering HFNC flow rates and its effect on intermittent hypoxia in preterm infants with respiratory insufficiency.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Flow Nasal Cannula']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare work of breathing on different levels of high flow respiratory support on infants born between 27 and 37 weeks gestation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Convenience sample of infants on HFNC admitted to our NICU who meet inclusion criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants between 27 and 37 weeks corrected gestational age\n* \\>4 days PNA\n* Stable (i.e. not meeting exclusion criteria) and receiving non-invasive respiratory support (HFNC) for ≥ 12 hours\n* Requiring ≤ 40% supplemental FiO2 as determined by the clinical care team for clinical care purposes independent of this study\n\nExclusion Criteria:\n\n* Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of WOB measurements'}, 'identificationModule': {'nctId': 'NCT03529994', 'briefTitle': 'Work of Breathing and Oxygen Saturation in Infants Receiving High Flow Nasal Cannula (HFNC)', 'organization': {'class': 'OTHER', 'fullName': 'Christiana Care Health Services'}, 'officialTitle': 'Work of Breathing and Oxygen Saturation Stability in Infants With Respiratory Insufficiency While Receiving Various Flow Rates of High Flow Nasal Cannula', 'orgStudyIdInfo': {'id': 'DDD603875'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Enrollment', 'interventionNames': ['Other: Enrollment']}], 'interventions': [{'name': 'Enrollment', 'type': 'OTHER', 'description': 'All infants enrolled will have work of breathing assessed.', 'armGroupLabels': ['Enrollment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health Services, Inc.', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}], 'overallOfficials': [{'name': 'Kelley Kovatis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christiana Care Health Services, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christiana Care Health Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alfred I. duPont Hospital for Children', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}