Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-02 @ 5:19 PM
Study NCT ID:
NCT02523820
Status:
COMPLETED
Last Update Posted:
2017-04-27
First Post:
2015-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nebulized Corticosteroid for Post Extubation Stridor in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012135', 'term': 'Respiratory Sounds'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2015-08-06', 'studyFirstSubmitQcDate': '2015-08-12', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-extubation stridor', 'timeFrame': '6 hours', 'description': 'patient who developed stridor after extubation within 6 hours'}], 'secondaryOutcomes': [{'measure': 'treatment failure', 'timeFrame': '24 hour', 'description': 'patient who required escalating of respiratory support such as noninvasive positive pressure ventilation or reintubation within 24 hours'}, {'measure': 'adverse events', 'timeFrame': '24 hour', 'description': 'hyperglycemia, oral thrust or GI bleeding'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stridor']}, 'referencesModule': {'references': [{'pmid': '28272175', 'type': 'RESULT', 'citation': 'Prasertsan P, Nakju D, Lertbunrian R, Chantra M, Anantasit N. Nebulized Fluticasone for Preventing Postextubation Stridor in Intubated Children: A Randomized, Double-Blind Placebo-Controlled Trial. Pediatr Crit Care Med. 2017 May;18(5):e201-e206. doi: 10.1097/PCC.0000000000001124.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and adverse effect of nebulized corticosteroid to prevent post-extubation stridor in children.', 'detailedDescription': 'The guideline for prevention and treatment of post-extubation stridor in children is inconclusive include Nebulized epinephrine and intravenous corticosteroid. Nebulized corticosteroid is alternative treatment for viral croup. the rationale of this study to evaluate the efficacy of nebulized fluticasone propionate to prevent pediatric post-extubation stridor'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children age between 1 month old - 18 year old who was intubated\n\nExclusion Criteria:\n\n* Palliative care\n* Anatomical abnormalities of airway; subglottic stenosis\n* Neuromuscular disease with negative inspiratory force \\< - 30 mmHg\n* Need positive pressure after extubation'}, 'identificationModule': {'nctId': 'NCT02523820', 'briefTitle': 'Nebulized Corticosteroid for Post Extubation Stridor in Children', 'organization': {'class': 'OTHER', 'fullName': 'Ramathibodi Hospital'}, 'officialTitle': 'Nebulized Corticosteroid for Post Extubation Stridor in Children: A Randomized Double Blind Controlled Trial', 'orgStudyIdInfo': {'id': 'ID10-57-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fluticasone propionate', 'description': 'Fluticasone 1 mg + Normal saline (NSS) upto 4 ml nebulized after extubation', 'interventionNames': ['Drug: fluticasone propionate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Normal saline (NSS) 4 ml nebulized after extubation', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'fluticasone propionate', 'type': 'DRUG', 'otherNames': ['Flixotide'], 'description': 'Flixotide 1 mg + NSS upto 4 ml nebulized after extubation. Record vital signs and modified Westley score at 0, 15, 30, 60 min and 2,4,6 hours', 'armGroupLabels': ['fluticasone propionate']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['normal saline'], 'description': 'NSS 4 ml nebulized after extubation. Record vital signs and modified Westley score at 0, 15, 30, 60 min and 2,4,6 hours', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Pediatric,Ramathibodi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Nattachai Anantasit, Assist Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ramathibodi Hospital, Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramathibodi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nattachai Anantasit', 'investigatorAffiliation': 'Ramathibodi Hospital'}}}}