Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-25 @ 5:00 PM
Study NCT ID:
NCT06958003
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-06
First Post:
2025-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003963', 'term': 'Diaper Rash'}], 'ancestors': [{'id': 'D017453', 'term': 'Dermatitis, Irritant'}, {'id': 'D003877', 'term': 'Dermatitis, Contact'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-04-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-05-02', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of diaper dermatitis', 'timeFrame': 'from admission to discharge from NICU, up to 6 months', 'description': 'Whether infant is diagnosed with diaper dermatitis while in the NICU'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diaper Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the use of 3-5 minutes air therapy for the prevention and treatment of diaper dermatitis in infants 30 weeks and older receiving care in the neonatal intensive care unit (NICU).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '30 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving care at Good Samaritan Hospital NICU\n* At least 30 weeks gestation at birth and corrected or older or corrected gestation\n* Birth to 1 year old\n* Stable vital signs (temperature, pulse, blood pressure, and oxygen saturation)\n\nExclusion Criteria:\n\n* Parent/legal guardian unable or unavailable to consent to involvement in the study\n* Congenital malformation impacting diaper area or spine'}, 'identificationModule': {'nctId': 'NCT06958003', 'briefTitle': 'Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime', 'orgStudyIdInfo': {'id': '24-091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Air Therapy', 'description': 'Patients with receive 3-5 minutes of air therapy in addition to routine diaper care', 'interventionNames': ['Other: Air Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Routine Care', 'description': 'Patients will receive routine diaper care'}], 'interventions': [{'name': 'Air Therapy', 'type': 'OTHER', 'description': '3-5 minutes of air therapy in addition to routine diaper care', 'armGroupLabels': ['Air Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Gina Marie Allaire', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TriHealth Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}