Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-30 @ 4:36 PM
Study NCT ID:
NCT05194761
Status:
UNKNOWN
Last Update Posted:
2022-02-01
First Post:
2021-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Saline Nebulization on Prevention of Extubation Failure in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-18', 'studyFirstSubmitDate': '2021-12-31', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reintubation by 72 hours post-extubation', 'timeFrame': 'within 72 hours', 'description': 'Number of participants with successful extubation'}], 'secondaryOutcomes': [{'measure': 'Lung ultrasound score', 'timeFrame': '72 hours', 'description': 'Number of participants with higher score may have worse prognosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'this study is about evaluating the effect of using normal saline nebulization in preventing re-intubation in extubated neonates , provided that the cause of intubation is mainly due to respiratory cause', 'detailedDescription': 'Using nebulization is of great debate in neonates especially post extubation as neonates have physiological characteristics such as difficult airway maintenance and clearance, smaller airway caliber, compliant chest wall, poor airway stability, and lower functional residual capacity that account for the diminished delivery of inhaled aerosol.\n\nNebulized normal saline has historically been used as a placebo typically in studies examining bronchodilator medications and sputum expectorants or used as a carrier to medications. Nowadays, normal saline is a method of enhancing mucociliary clearance has become a clinically accepted adjunct to physiotherapy in the treatment of many chronic lung conditions .\n\nthe effect of whether or not nebulization really improves the lung condition is evaluated by lung ultrasound ,It is not only useful in predicting failure of non-invasive ventilation and the need for invasive ventilation, but also has a great value in anticipating extubation success In general, patients with lower lung ultrasound scores show a better chance of extubation success. Each lung will be divided into 3 areas (upper anterior, lower anterior, and lateral) and will be examined using a linear microprobe through both transverse and longitudinal scans. For each lung area, a 0- to 3-point score was given (total score ranging from 0-18).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ventilated babies with primary respiratory disease as the provisional and primary cause of intubation immediately post-extubation.\n\nExclusion Criteria:\n\n* Neurological, cardiac, surgical or metabolic problems affecting their respiration.\n\nUpper obstructive air way disease that might affect the success of extubation.'}, 'identificationModule': {'nctId': 'NCT05194761', 'briefTitle': 'Normal Saline Nebulization on Prevention of Extubation Failure in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Normal Saline Nebulization in Prevention of Extubation Failure in Neonates', 'orgStudyIdInfo': {'id': 'AinShamsUPed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'using nebulization', 'description': 'extubated neonates will be divided in two group , one will receive saline nebulization for 3 days postextubation ,', 'interventionNames': ['Drug: Normal saline']}, {'type': 'NO_INTERVENTION', 'label': 'No nebulization', 'description': 'the other group will only receive the standard only'}], 'interventions': [{'name': 'Normal saline', 'type': 'DRUG', 'description': 'Using normal saline nebulization in neonates postextubation', 'armGroupLabels': ['using nebulization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Olivia Saroufim, MSC', 'role': 'CONTACT', 'email': 'oliviazakariasalama@gmail.com', 'phone': '01225801384'}, {'name': 'Ghada Saleh, MD', 'role': 'CONTACT', 'email': 'GhadaSaleh@med.asu.edu.eg', 'phone': '01148777714'}], 'facility': 'AinShams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Olivia Zakaria, MSC', 'role': 'CONTACT', 'email': 'oliviazakariasalama@gmail.com', 'phone': '01225801484'}, {'name': 'Ghada Saleh, MD', 'role': 'CONTACT', 'email': 'ghadasaleh@med.asu.edu.eg', 'phone': '01148777714'}], 'overallOfficials': [{'name': 'Rania ElFarrash, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}, {'name': 'Ibrahim Abuseif, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Olivia Zakaria ,MSC', 'investigatorAffiliation': 'Ain Shams University'}}}}