Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-01 @ 9:34 AM
Study NCT ID:
NCT07383051
Status:
RECRUITING
Last Update Posted:
2026-02-03
First Post:
2026-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Clinical Trial for Predictors of Successful Extubation of Pediatric Patients From Mechanical Ventilation Either on High Velocity Nasal Insufflation or Simple Nasal Oxygen and Comparing the Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'comparing the outcome between High Velocity Nasal Insufflation and simple oxygen after successful weaning from mechanical ventilation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-26', 'studyFirstSubmitDate': '2026-01-26', 'studyFirstSubmitQcDate': '2026-01-26', 'lastUpdatePostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparing the need for reintubation within 48 hours afterr extubation using High Velocity Nasal Insufflation versus simple oxygen', 'timeFrame': '48 hours', 'description': 'Successful extubation with no need for reintubation within 48 hours among pediatric ICU patients in those using High Velocity Nasal Insufflation versus simple oxygen'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Comparing the Outcome Between High Velocity Nasal Insufflation and Simple Oxygen After Successful Weaning From Mechanical Ventilation']}, 'descriptionModule': {'briefSummary': 'A randomized clinical trial about predictors of successful extubation of pediatric patients from mechanical ventilation either on High Velocity Nasal Insufflation or simple nasal oxygen and comparing the outcome', 'detailedDescription': 'A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or reintubation within 48 hours, presence of respiratory distress or stridor post extubation, knowing mechanical ventilaton free days after extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 2 months and 13 years old with minimum weight 4kg\n* Both sexes\n* Patients on mechanical ventilation for at least 24 hours for any indication\n\nExclusion Criteria:\n\n* Patients not ready for weaning from mechanical ventilation\n* Contraindications to use of High velocity nasal insufflation\n* Prolonged mechanical ventilation for more than 21 days'}, 'identificationModule': {'nctId': 'NCT07383051', 'briefTitle': 'Randomized Clinical Trial for Predictors of Successful Extubation of Pediatric Patients From Mechanical Ventilation Either on High Velocity Nasal Insufflation or Simple Nasal Oxygen and Comparing the Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Predictors of Successful Extubation of Pediatric Patients From Mechanical Ventilation With or Without Post Extubation High Velocity Nasal Insufflation', 'orgStudyIdInfo': {'id': 'MD-299-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exubation of pediatric patients on High Velocity Nasal Insufflation', 'interventionNames': ['Device: Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen', 'Device: comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exubation of pediatric patients on simple oxygen', 'interventionNames': ['Device: Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen', 'Device: comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients']}], 'interventions': [{'name': 'Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen', 'type': 'DEVICE', 'description': 'A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or reintubation within 48 hours, presence of respiratory distress or stridor post extubation, knowing mechanical ventilaton free days after extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality.', 'armGroupLabels': ['Exubation of pediatric patients on High Velocity Nasal Insufflation', 'Exubation of pediatric patients on simple oxygen']}, {'name': 'comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients', 'type': 'DEVICE', 'description': 'A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or reintubation within 48 hours, presence of respiratory distress or stridor post extubation, knowing mechanical ventilaton free days after extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality.', 'armGroupLabels': ['Exubation of pediatric patients on High Velocity Nasal Insufflation', 'Exubation of pediatric patients on simple oxygen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Cairo University Cairo University', 'role': 'CONTACT'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Sherin Tarek Fayez Ali, Pediatric ICU specialist', 'role': 'CONTACT', 'email': 'tareksherin16@gmail.com', 'phone': '+01153576707'}], 'overallOfficials': [{'name': 'Cairo University Cairo University', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cairo University', 'investigatorFullName': 'Sherin Tarek Fayez Ali', 'investigatorAffiliation': 'Cairo University'}}}}