NCT00393900

Brief Summary

This study will determine if the investigators can use certain tests (eustachian tube function tests and gas exchange tests) to predict whether or not a child who had tubes surgically placed in their eardrum because of middle-ear disease will redevelop the disease again after the tubes quit working.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2006

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

6.2 years

First QC Date

October 30, 2006

Last Update Submit

October 17, 2017

Conditions

Otitis Media With Effusion

Keywords

otitis mediatympanostomy tubeeustachian tube functiongas exchangetympanostomy tubes

Outcome Measures

Primary Outcomes (1)

  • middle ear status

    middle-ear status at 12 months after tympanostomy tube became non-functional

    12 months

Study Arms (1)

1

Children with tympanostomy tubes for chronic OME

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children 3-6 years old who underwent tympanostomy tube insertion for chronic otitis media with effusion within the 6 weeks prior to study enrollment

You may qualify if:

  • years old
  • History of chronic otitis media with effusion(OME)
  • Scheduled or within 6 weeks of tube insertion
  • OME at entry or surgery
  • Generally good health

You may not qualify if:

  • Cleft palate or other syndromes predisposing to OM
  • History of recurrent acute otitis media only
  • History of complications of OM or its treatment
  • Unable to cooperate for testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ENT Department, Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Mandel EM, Swarts JD, Casselbrant ML, Tekely KK, Richert BC, Seroky JT, Doyle WJ. Eustachian tube function as a predictor of the recurrence of middle ear effusion in children. Laryngoscope. 2013 Sep;123(9):2285-90. doi: 10.1002/lary.24021. Epub 2013 Apr 10.

    PMID: 23575552RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Buccal cells obtained for DNA

MeSH Terms

Conditions

Otitis Media with EffusionOtitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • William J Doyle, PhD

    Department of Otolaryngology, Children's Hospital of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • Ellen Mandel, MD

    University of Pittsburgh

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 30, 2006

First Posted

October 31, 2006

Study Start

August 1, 2006

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 19, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)