Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-30 @ 1:55 AM
Study NCT ID:
NCT06917768
Status:
COMPLETED
Last Update Posted:
2025-04-17
First Post:
2025-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'It is an interventional, prospective, non randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2025-04-01', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the effectiveness of low-dose, short-term oral corticosteroids in the treatment of OSA in children.', 'timeFrame': '6 months', 'description': 'In Group 2, failure of medical treatment is defined by a persistence of apnea assessed by the clinician and parents and therefore a need for surgery within 6 months of follow-up, while therapeutic success reflects an improvement in symptoms and a disappearance of apnea documented by video, and therefore the absence of need for surgery after 6 months of follow-up.'}], 'secondaryOutcomes': [{'measure': "Evaluate the evolution of symptoms' severity", 'timeFrame': '6 months', 'description': "Evaluation at 1, 3 and 6 months of treatment (or surgery) the evolution of the OSA-related symptoms through the Pediatric Sleep Questionnaire.\n\nThe Pediatric Sleep Questionnaire consists of 22 questions related to Pediatric OSA. The score is graded from 0 to 22 and is proportional to symptoms' severity (a higher score means a more severe sleep apnea)."}, {'measure': "Evaluate tonsils' size evolution with treatment", 'timeFrame': '6 months', 'description': "Evaluation at 1, 3 and 6 months of the evolution of tonsils' size through clinical evaluation using the Brodsky Score for tonsil size evaluation.\n\nBrodsky score can be 0, 1, 2, 3 or 4. A higher score reflects bigger tonsils."}, {'measure': 'Evaluate potential treatment-related side effects', 'timeFrame': '6 months', 'description': 'Evaluation of any potential treatment-related side effect through clinical interrogation at 1,3 and 6 months.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Corticosteroids', 'Tonsillar hypertrophy', 'Pediatric OSA', 'Surgery', 'Coblation'], 'conditions': ['Pediatric Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '31375615', 'type': 'BACKGROUND', 'citation': 'Fernandes RM, Wingert A, Vandermeer B, Featherstone R, Ali S, Plint AC, Stang AS, Rowe BH, Johnson DW, Allain D, Klassen TP, Hartling L. Safety of corticosteroids in young children with acute respiratory conditions: a systematic review and meta-analysis. BMJ Open. 2019 Aug 1;9(8):e028511. doi: 10.1136/bmjopen-2018-028511.'}, {'pmid': '16735907', 'type': 'BACKGROUND', 'citation': 'Mitchell RB, Pereira KD, Friedman NR. Sleep-disordered breathing in children: survey of current practice. Laryngoscope. 2006 Jun;116(6):956-8. doi: 10.1097/01.MLG.0000216413.22408.FD.'}, {'pmid': '17118282', 'type': 'BACKGROUND', 'citation': 'Meltzer LJ, Mindell JA. Sleep and sleep disorders in children and adolescents. Psychiatr Clin North Am. 2006 Dec;29(4):1059-76; abstract x. doi: 10.1016/j.psc.2006.08.004.'}]}, 'descriptionModule': {'briefSummary': "This prospective interventional clinical trial (non-randomized) aims to evaluate oral corticosteroids' role as an alternative to surgery (gold-standard) in the treatment of obstructive sleep apnea in children. It also evaluates the evolution of symptoms' severity as well as any side effects linked to treatment.\n\nThis prospective study included children aged between 18 months and 8 years who consulted the same pediatric ENT physician's clinic for OSA secondary to adenotonsillar hypertrophy with no other comorbidities. They were divided into 2 Groups. Children undergoing intracapsular adenotonsillectomy by Coblation™ (Group 1) were compared to those receiving oral prednisolone at a dose of 1mg/kg for 5 days and 1 month of intranasal corticosteroids (Group 2). The follow-up tools were the Pediatric Sleep Questionnaire (PSQ) score and the size of the tonsils (Brodsky classification) evaluated at 1, 3 and 6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '18 Months', 'genderBased': False, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children aged between 18 months and 8 years diagnosed with OSAS secondary to adenotonsillar hypertrophy\n\nExclusion Criteria:\n\n* Children under 18 months or over 8 years old\n* History of acute or chronic cardiorespiratory neuromuscular, or metabolic diseases\n* Congenital craniofacial anomalies\n* Chromosomal disorders\n* Epilepsy'}, 'identificationModule': {'nctId': 'NCT06917768', 'briefTitle': "Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea", 'organization': {'class': 'OTHER', 'fullName': 'Hotel Dieu de France Hospital'}, 'officialTitle': "Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea, a Non-Randomized Controlled Trial.", 'orgStudyIdInfo': {'id': 'Tfem/2023/50'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients undergoing surgical treatment (adenotonsillectomy).', 'description': 'Children undergoing adenoidectomy and intracapsular tonsillectomy using Coblation™, by the same surgeon at HDF.', 'interventionNames': ['Procedure: Adenotonsillectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Patients undergoing medical treatment (short-term and low dose oral corticosteroids).', 'description': 'The second Group includes children whose parents have refused surgery despite informed understanding of the therapeutic algorithm of OSA. They received medical treatment consisting of a 1-month treatment with intranasal corticosteroids, coupled with a 5-day course of oral corticosteroids (prednisolone) at a safe dose of 1mg/kg.', 'interventionNames': ['Drug: Prednisolone']}], 'interventions': [{'name': 'Adenotonsillectomy', 'type': 'PROCEDURE', 'otherNames': ['Coblation'], 'description': 'Children undergoing adenoidectomy and intracapsular tonsillectomy using Coblation™, by the same surgeon at HDF.', 'armGroupLabels': ['Patients undergoing surgical treatment (adenotonsillectomy).']}, {'name': 'Prednisolone', 'type': 'DRUG', 'description': 'The second Group includes children whose parents have refused surgery despite informed understanding of the therapeutic algorithm of OSA. They received medical treatment consisting of a 1-month treatment with intranasal corticosteroids, coupled with a 5-day course of oral corticosteroids (prednisolone) at a safe dose of 1mg/kg.', 'armGroupLabels': ['Patients undergoing medical treatment (short-term and low dose oral corticosteroids).']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Hotel Dieu de France', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Simon J Rassi, Medical Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hotel Dieu de France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hotel Dieu de France Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Oliver Majdalani', 'investigatorAffiliation': 'Hotel Dieu de France Hospital'}}}}