Autoinflation for Aboriginal and Torres Strait Islander Children with OME (middle ear infection)
- Conditions
- Otitis Media with EffusionHealth of Aboriginal ChildrenEar - Other ear disordersInfection - Other infectious diseases
- Registration Number
- ACTRN12617001652369
- Lead Sponsor
- Western Sydney University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
1. Aboriginal and Torres Strait Islander
2. Aged 3 -16 years
3. Type B tympanogram in at least one ear
Child has current acute upper respiratory infection;
Current acute otitis media (defined as a Type B tympanogram plus either ear pain or a bulging ear drum on otoscopy);
Current perforated tympanic membrane or current grommet (ventilation tube);
Planned ENT surgery within next 1 month;
Children with a latex allergy;
A nosebleed in the last 3 weeks, or more than 1 nosebleed in the preceding 6 months;
A condition which increases the risk of complications (e.g. immunosuppression, genetic or chromosomal abnormality, cleft palate or mid-face abnormalities such as seen in Down Syndrome)
Inability to use the autoinflation device.
Previous participation in INFLATE
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of children showing improvement of OME determined by change of at least one Type B tympanogram to a normal Type A or C1 tympanogram at Month 1 (OME improved by child).[ Month 1]
- Secondary Outcome Measures
Name Time Method