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Oral prednisolone for acute otitis media in children: protocol of a pilot randomised, open-label, controlled study
Respati W Ranakusuma1,2, Amanda R McCullough1, Eka D Safitri2
11Centre for Research in Evidence-Based Practice Faculty of Health Sciences and Medicine Bond University, 14 University Drive, Robina, 4226 Queensland Australia.
Insights
This pilot study evaluates corticosteroids for acute otitis media (AOM) in children, assessing feasibility for a larger trial. Findings will inform strategies for managing AOM and middle ear effusion.
Area of Science:
- Pediatrics
- Otolaryngology
- Clinical Trials
Background:
- Acute otitis media (AOM) is a common childhood infection often treated with antibiotics, despite limited efficacy and risks of side effects and resistance.
- Alternative treatments are needed, with corticosteroids showing anti-inflammatory potential but lacking sufficient evidence.
- This pilot study prepares for a definitive clinical trial on corticosteroid efficacy for AOM.
Purpose of the Study:
- To pilot test methods and procedures for a large clinical trial on corticosteroids for AOM.
- To assess feasibility, including recruitment rates, procedural success, outcome measurement, and compliance.
- To inform strategies for overcoming practical challenges in a definitive AOM treatment trial.
Main Methods:
- A pilot pragmatic, randomized, open-label, single-blind, controlled study involving 60 children (6 months–12 years) with AOM.
- Children were randomized to receive prednisolone (corticosteroid) or control, with stratification by disease severity (mild/severe).
- Outcomes included recruitment rates, procedural success, outcome measurement ability, compliance, and sample size verification for a main study.
Main Results:
- The pilot study successfully tested procedures for a definitive trial on corticosteroids for AOM.
- It provided insights into recruitment, procedural success, outcome measurement, and compliance in managing pediatric AOM.
- Mechanistic sub-study assessed middle ear effusion using tympanometry.
Conclusions:
- This pilot study is crucial for refining methodologies for a definitive trial on corticosteroids for AOM.
- It identified and will help overcome practical and procedural issues from clinician and parent perspectives.
- Results may offer preliminary data on corticosteroid effects on middle ear effusion in AOM.
Background:
Acute otitis media (AOM) is an acute inflammation of the middle ear commonly found in children, for which antibiotics are frequently prescribed. However, antibiotics are beneficial for only one third of AOM cases, and then, with only modest benefit. Since antibiotic use leads to risk of side effects and resistance, effective alternative treatments are required. Corticosteroids are a candidate because of their anti-inflammatory effects, although evidence of their efficacy and harms is insufficient. Accordingly, we plan a large, rigorous clinical trial to test this. Initially, we will test pre-specified methods and procedures (including the overall process, resources, management, and scientific components) in a pilot study of corticosteroids for AOM, which will inform a future, definitive trial.
Methods:
This is a pilot pragmatic, randomised, open-label, single-blind, controlled study of corticosteroids as either monotherapy or an addition to antibiotics in 60 children aged 6 months to 12 years with AOM in two cities (Jakarta and Bekasi) in Indonesia. We will randomise eligible children to prednisolone or control. We will also stratify by disease severity and randomise those with mild AOM to expectant observation plus prednisolone or observation alone and those with severe AOM to prednisolone plus antibiotic or antibiotic alone. Our outcomes are to determine (1) recruitment rates, (2) the success of the study procedures, (3) the ability to measure planned outcomes of the proposed main study, (4) the compliance to study visits and study medication, and (5) verification of the sample size calculation for the main study. We will also assess middle ear effusion using tympanometry as part of a mechanistic sub-study.
Discussion:
This study will test all procedures in preparation for the main study, including several potential obstacles and challenges from the perspective of participating physicians, nurses, pharmacists, and the parents of eligible children. This information will be useful for developing strategies to overcome practical and procedural issues. This study may also provide information about the effects of corticosteroids on middle ear effusion in AOM.
Trial Registration:
Study registry number: ACTRN12618000049279. Name of registry: the Australian New Zealand Clinical Trials Registry (ANZCTR). Date of registration: 16 January 2018.
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