IHEARBETA Primary outcomes

Menzies School of Health Research

Dataset description

Demographics - Location (by Northern Territory region) - Ethnicity (all Australian First Nations) Baseline / randomisation characteristics (Table 1 in publication) - Birth characteristics (birth weight, gestational age, maternal smoking) - Randomisation characteristics (weight, age, breastfeeding status, household smoking, environmental smoke, family history 'runny ears') Randomisation allocation (treatment group) and treatment given Otitis media diagnosis at baseline, 16 weeks (primary outcome) and 12 months. Additional antibiotic management data (clinical failure) in the 16 week intervention period. Primary outcome hearing data. Basic microbiologic data from ear discharge.
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Source Study

Trial acronym

I HEAR BETA (Indigenous Healthy EARs- BEtadine, Tissues and Antibiotics)

Trial ID





Phase 4


Government body,National Health and Medical Research Council (NHMRC)

Scientific enquiries

Prof Amanda Leach

Brief Summary

This is a 2x2 factorial design randomised controlled trial of 4 months therapy with oral cotrimoxazole versus placebo and topical povidone iodine versus no wash, in addition to standard treatment to resolve chronic suppurative otitis media (runny ears) in children 2 months to less than 17 years of age. Standard treatment is twice daily dry mopping and topical ciprofloxacin drops.

Key Inclusion Criteria

Indigenous children 2 months to 17 years of age and residing in participating communities, with a diagnosis of unilateral or bilateral chronic suppurative otitis media (CSOM) are eligible to participate in this study.

Key Exclusion Criteria

Children who are ineligible include those who; i) have been previously randomised; ii) have ciprofloxacin, cotrimoxazole or iodine allergy; iii) had mastoid surgery in the preceding 12 months; iv) have ear surgery scheduled in the next 4 months; v) have congenital ear or hearing problems; vi) are known to have immunodeficiency; or vii) are pregnant.

Can healthy volunteers participate?




Sample Size    280

Min. age    2 Months

Max. age    17 Years

Sex    Both males and females

Condition category    chronic suppurative otitis media (CSOM)

Condition code    Ear


Intervention code Treatment: Drugs

Oral Intervention: Placebo or Sulfamethoxazole-trimethoprim (cotrimoxazole, 4mg/kg per dose of trimethoprim component) given orally twice daily for 16 weeks. Topical Intervention: Povidone-iodine 0.5% (Betadine 'registered trademark') given twice daily as an ear wash (1:20 mixed with clean water), >=20mls per discharging ear. This treatment will be given prior to the standard recommended treatment of dry mopping with tissue spears and ciprofloxacin drops. Topical treatment regimens should contin ....
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Control group Placebo

There is one control arm (standard treatment only- no oral or additional topical intervention) and 3 comparator arms. Oral comparator/control: A placebo medication that is identical in appearance, smell and taste as cotrimoxazole. Topical comparator: no povidone-iodine wash. Standard topical treatment (Northern Territory) for all children: Dry mopping with tissue spears and ciprofloxacin drops 5 drops twice a day. Treatment regimens should continue until the ear has been without discharge for 3 ....
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Outcome: Failure will be defined as presence of ear discharge in either ear, assessed by a trained research nurse using video-otoscopy before cleaning the ear canal. The primary analysis will report the absolute risk difference and 95% confidence interval for: (i) The difference in failure rates between children allocated to receive the povidone-iodine ear wash plus standard treatment, and children allocated to receive standard treatment alone; (ii) The difference in failure r ....
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The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see