Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-22 @ 3:48 PM
Study NCT ID:
NCT04282369
Status:
UNKNOWN
Last Update Posted:
2020-02-24
First Post:
2020-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-21', 'studyFirstSubmitDate': '2020-02-17', 'studyFirstSubmitQcDate': '2020-02-21', 'lastUpdatePostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Silverman Score', 'timeFrame': '6 months', 'description': 'The respiratory status of the newborns will be evaluated with the scoring system defined by Silverman.'}], 'secondaryOutcomes': [{'measure': 'N-PASS score', 'timeFrame': '6 months', 'description': 'evaluation of the comfort of the four different noninvasive ventilation modes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiratory distress, newborn, noninvasive ventilation'], 'conditions': ['Respiratory Disease', 'Respiratory Insufficiency']}, 'descriptionModule': {'briefSummary': 'Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress', 'detailedDescription': 'In this study, it is aimed to search the efficacy and comfort of the four different non-invasive ventilation modes in the delivery room. HHFNC, NCPAP, NIPPV and NHFO modes are used for the respiratory distress of the late preterm and term babies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* late preterm and term infants with respiratory distress\n\nExclusion Criteria:\n\n* intubation for the respiratory distres.\n* major abnormalities'}, 'identificationModule': {'nctId': 'NCT04282369', 'briefTitle': 'Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress', 'orgStudyIdInfo': {'id': '32342545'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HHFNC', 'description': 'In this group patients will receive respiratory support by high flow nasal cannula.', 'interventionNames': ['Device: HHHFNC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nCPAP', 'description': 'In this group patients will receive respiratory support by nasal CPAP.', 'interventionNames': ['Device: NCPAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nIPPV', 'description': 'In this group patients will receive respiratory support by nasal IPPV.', 'interventionNames': ['Device: NIPPV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nHFO', 'description': 'In this group patients will receive respiratory support by nasal high frequency oscillatory. ventilation.', 'interventionNames': ['Device: NHFO']}], 'interventions': [{'name': 'HHHFNC', 'type': 'DEVICE', 'description': 'noninvasive ventilation modality', 'armGroupLabels': ['HHFNC']}, {'name': 'NCPAP', 'type': 'DEVICE', 'description': 'noninvasive ventilation modality', 'armGroupLabels': ['nCPAP']}, {'name': 'NIPPV', 'type': 'DEVICE', 'description': 'noninvasive ventilation modality', 'armGroupLabels': ['nIPPV']}, {'name': 'NHFO', 'type': 'DEVICE', 'description': 'noninvasive ventilation modality', 'armGroupLabels': ['nHFO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34065', 'city': 'Istanbul', 'status': 'COMPLETED', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni Sultan Suleyman Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ilker gönen', 'role': 'CONTACT', 'email': 'ilkergonen81@hotmail.com', 'phone': '+905322054822'}], 'facility': 'Kanuni Sultan Suleyman Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'ilker gönen', 'role': 'CONTACT', 'email': 'ilkergonen81@hotmail.com', 'phone': '+905322054822'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neonatologist', 'investigatorFullName': 'Ilker Gönen', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}