Watchful waiting for urban Aboriginal and Torres Strait Islander Children with Acute Otitis Media (middle ear infection)

Not Applicable

Recruiting

• Conditions: Acute Otitis Media; Health of Urban Aboriginal children; Ear - Other ear disorders; Infection - Studies of infection and infectious agents; Public Health - Epidemiology

• Registration Number: ACTRN12613001068752
• Lead Sponsor: Western Sydney University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-24
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 495

Inclusion Criteria

1. Aboriginal and/or Torres Strait Islander child (as defined by the health service they are attending)
2. Aged 18 months to 16 years (inclusive)
3. First enrolment into the study
4. Current acute otitis media without perforation diagnosed by a medical practitioner due to fluid in the middle ear on tympanometry (Type B tympanogram) and at least one of the following:
bulging of the eardrum on otoscopy,
ear pain

Exclusion Criteria

The child has been on any antibiotic in the previous 4 days
At high risk of chronic suppurative otitis media (CSOM), as defined by residing in geographic area known to have prevalence of CSOM >4%
A grommet in situ, or current or past history of tympanic membrane perforation
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)
Systemic features necessitating antibiotic treatment (e.g.,
septicaemia, meningitis, pneumonia, or urinary tract infection)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of children with clinical resolution of AOM, defined as all of the following: no pain, no fever >38oC, no bulging eardrum and no complications of otitis media (no perforation or mastoiditis) assessed by:<br><br>1.GP or Nurse Practitioner clinical examination on Day 7*<br>2.Where 1 is not available, GP/Nurse Practitioner assessment of parental report and review of video pneumatic otoscopy, and no fever >38oC[Day 7 (acceptable range Day 5-10).]