Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
Study NCT ID:
NCT00162994
Status:
UNKNOWN
Last Update Posted:
2005-12-21
First Post:
2005-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention Recurrent Otitis Media in the Young Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000233', 'term': 'Adenoidectomy'}], 'ancestors': [{'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-02', 'completionDateStruct': {'date': '2005-08'}, 'lastUpdateSubmitDate': '2005-12-20', 'studyFirstSubmitDate': '2005-09-10', 'studyFirstSubmitQcDate': '2005-09-10', 'lastUpdatePostDateStruct': {'date': '2005-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- number of acute otitis media'}, {'measure': '- quality of life issues'}], 'secondaryOutcomes': [{'measure': '- time to first recurrence'}, {'measure': '- speed of recovery of each otitis media'}, {'measure': '- number of days of middle ear effusion'}, {'measure': '- number of upper respiratory infections'}, {'measure': '- prevention of otitis media caused by pnemococcus in carrier of pneumococcus'}]}, 'conditionsModule': {'keywords': ['recurrent otitis media', 'adenoidectomy', 'tympanostomy', 'young children', 'prevention', 'quality of life'], 'conditions': ['Otitis Media']}, 'referencesModule': {'references': [{'pmid': '24445832', 'type': 'DERIVED', 'citation': 'Kujala T, Alho OP, Kristo A, Uhari M, Renko M, Pokka T, Koivunen P. Quality of life after surgery for recurrent otitis media in a randomized controlled trial. Pediatr Infect Dis J. 2014 Jul;33(7):715-9. doi: 10.1097/INF.0000000000000265.'}, {'pmid': '22466327', 'type': 'DERIVED', 'citation': 'Kujala T, Alho OP, Luotonen J, Kristo A, Uhari M, Renko M, Kontiokari T, Pokka T, Koivunen P. Tympanostomy with and without adenoidectomy for the prevention of recurrences of acute otitis media: a randomized controlled trial. Pediatr Infect Dis J. 2012 Jun;31(6):565-9. doi: 10.1097/INF.0b013e318255ddde.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if young children have more benefit of the combination of adenotomy and tympanostomy than plain tympanostomy in prevention of recurrent otitis media.', 'detailedDescription': 'Recurrent otitis media is the most common bacterial disease in young children. Many risk factors are known, but benefit of operations are conflicting in children under two years of age.\n\nIn this randomized prospective controlled trial, the effect of tympanostomy tubes is compared to the effect of the combination of adenotomy and tympanostomy tubes in preventing recurrent otitis media. A control group with no active treatment is also included. The speed of recovery is studied by recording the daily symptoms and number of days of effusion comparing the differences between the groups. Life quality issues are recorded preoperatively and at about four and twelve months after the operation and are compared between the groups and to healthy children of the same age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '10 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 3 otitis media episodes during the last half year\n* address near (\\< 50 km) the university hospital of Oulu\n\nExclusion Criteria:\n\n* otitis media effusion lasting longer than two months without acute exacerbations\n* prior adenoidectomy or tympanostomy\n* head or neck malformation\n* retarded child\n* serious disease\n* chemoprophylaxis for another disease'}, 'identificationModule': {'nctId': 'NCT00162994', 'briefTitle': 'Prevention Recurrent Otitis Media in the Young Children', 'organization': {'class': 'OTHER', 'fullName': 'Oulu University Hospital'}, 'officialTitle': 'Effect of Adenotomy and Tympanostomy on Preventing Recurrent Otitis Media in the Young Children', 'orgStudyIdInfo': {'id': 'K53715'}}, 'armsInterventionsModule': {'interventions': [{'name': 'adenoidectomy and tymapanostomy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Petri Koivunen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dept of Otolaryngology, University of Oulu, Finland'}, {'name': 'Olli-Pekka Alho, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Otolaryngology, University of Oulu, Finland'}, {'name': 'Matti Uhari, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dept of Pediatrics, University of Oulu, Finland'}, {'name': 'Tiia Kujala, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Otolaryngology, University of Oulu, Finland'}, {'name': 'Jukka Luotonen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dept of Otolaryngology, University of Oulu, Finland'}, {'name': 'Aila Kristo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Otolaryngology, University of Oulu, Finland'}, {'name': 'Marjo Renko, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of pediatrics, University of Oulu, Finland'}, {'name': 'Tero Kontiokari, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of pediatrics, University of Oulu, Finland'}, {'name': 'Tytti Pokka, FK', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of pediatrics, University of Oulu, Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oulu University Hospital', 'class': 'OTHER'}}}}