Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016497
Status:
TERMINATED
Last Update Posted:
2006-04-24
First Post:
2001-05-10
Brief Title:
Adenoidectomy for Otitis Media in 2-3 Year Old Children
Sponsor:
National Institute on Deafness and Other Communication Disorders NIDCD
Organization:
National Institute on Deafness and Other Communication Disorders NIDCD
Study Overview
Official Title:
Adenoidectomy for Otitis Media in 2-3 Year Old Children
Status:
TERMINATED
Status Verified Date:
2006-04
Last Known Status:
None
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 evaluate the efficacy of three different surgical treatments 1 Bilateral myringotomy and tube insertion MT 2 Adenoidectomy and bilateral myringotomy AT 3 Adenoidectomy with myringotomy and tympanostomy tube insertion A-MT in reducing subsequent episodes of middle ear disease and hearing loss caused by the fluid in the middle ear in children aged 24-47 months The fluid in the middle ear is of at least three months duration and unresponsive to standardized recent antimicrobial treatment The children are assigned to one of the three surgical treatments After surgery they are followed with examinations monthly and at the time of intercurrent infections for three years
Detailed Description:
The specific aim of this study is to compare by means of a randomized clinical trial the efficacy of three surgical treatment combinations adenoidectomy with myringotomy A-M adenoidectomy with myringotomy and tympanostomy tube insertion A-MT and MT alone in reducing subsequent middle ear disease in children aged 24-47 months with otitis media with effusion OME of at least 3 months duration unresponsive to standardized recent antimicrobial treatment The children are randomly assigned to one of three treatment arms 1 MT 2 A-M and 3 A-MT Subjects are be stratified according to 1 age 2 nasal obstruction and 3 previous tubes All subjects are scheduled for surgery according to assignment within 4 weeks after entry The first post-operative visit takes place 2 weeks after surgery and a complete examination of the ears nose and throat ENT exam including pneumatic otoscopy tympanometry and audiometry is performed Subjects are followed with monthly evaluations ENT-exam pneumatic otoscopy tympanometry for three years Audiometry is performed every 6 months All subjects are evaluated at any time while still enrolled in the study if signs and symptoms of URI acute otitis media AOM including otorrhea or OME occur and are treated appropriately Subjects who develop OME for 4 months bilaterally or 6 months unilaterally have MT and continue to be followed in the study The primary outcome measure will be percentage of time with middle ear effusion MEE Episodes of AOM otorrhea and OME time to first recurrence and number of surgical procedures will be compared between the three treatment groups Treatment failures complications and sequelae of treatments will also be recorded and compared among the three treatment groups
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