Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162994
Status:
UNKNOWN
Last Update Posted:
2005-12-21
First Post:
2005-09-10
Brief Title:
Prevention Recurrent Otitis Media in the Young Children
Sponsor:
Oulu University Hospital
Organization:
Oulu University Hospital
Study Overview
Official Title:
Effect of Adenotomy and Tympanostomy on Preventing Recurrent Otitis Media in the Young Children
Status:
UNKNOWN
Status Verified Date:
2002-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
In 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
In 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None