Natural History Study of Incidence of Otorrhea Following Tympanostomy Tube Insertion in Children 6 Months to 12 Years

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01111877

Enrollment

1389

Registered

2010-04-28

Start date

2010-05-31

Completion date

2011-11-30

Last updated

2012-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otorrhea

Keywords

ear tubes, ear drainage, ear infection, ear drops, tympanostomy tubes, Pediatric patients

Brief summary

This study was conducted to describe the time to first incidence of otorrhea post tympanostomy tube insertion.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

6 Months to 12 Years

Healthy volunteers

Inclusion criteria

* Participants must be at least 6 months old and no more than 13 years of age at the time of enrollment scheduled for unilateral or bilateral myringotomy and tympanostomy tube insertion. Patients and/or child must read/sign informed consent and comply with requirement of the study.

Exclusion criteria

* There are no

Design outcomes

Primary

Measure	Time frame
Incidence of, time to, and relationship of risk factors associated with otorrhea post tympanostomy tube insertion.	Up to 1 year

Countries

United States

Outcome results