Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT00736112
Eligibility Criteria:
Inclusion Criteria:
1. Otoscopy reveals Chronic OME.
2. Tympanometry confirms fluid in middle ear.
3. Children \<4 years old
4. Lack of improvement after three months of antibiotic therapy.
5. History of persistent effusion for three or more months per-episode of OM.
6. \>3 episodes of AOM in preceding 6 months or \>5 episodes of AOM during preceding 12 months
7. Bilateral conductive hearing loss of 15 dB or more.
Exclusion Criteria:
1. Previous adenotonsillar surgery or placement of tympanostomy tubes.
2. Children with inhalant allergies including asthma.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
4 Years
Study:
NCT00736112
Study Brief:
Protocol Section:
NCT00736112