Otitis Media Clinical Trial
Official title:
Amoxycillin Versus Placebo for Resolution of Otitis Media With Effusion and Prevention of Acute Otitis Media With Perforation in Aboriginal Infants: a Randomised Controlled Trial.
This clinical trial was conducted in a population where tympanic membrane perforation occurs
in 60% infants in the first year of life. Nasopharyngeal colonisation (nasal contamination)
with pathogenic bacteria occurs within weeks of life and predicts persistent middle ear
infection throughout childhood. The trial aimed to assess whether twice daily antibiotics
commencing at first detection of middle ear effusion would cure the infection and/or prevent
disease progression, compared to placebo.
The study was conducted in three remote Aboriginal communities in the Northern Territory of
Australia. The annual birth cohort was 45.
Aboriginal infants were seen as soon as possible after birth, and at 2 weekly intervals
until middle ear effusion was detected by pneumatic otoscopy and tympanometry. Following
consent, infants were randomised to either amoxycillin(50 mg/kg/d BD) or placebo equivalent
for up to 24 weeks, or until normal middle ear status was detected at 2 consecutive monthly
scheduled examinations. At monthly examinations the infant also had a general health check,
parents were interviewed, child's medical record was reviewed, and nasopharyngeal swabs were
collected.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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