Oral prednisolone for acute middle ear infection in childre

Phase 3

Completed

• Conditions: Acute otitis media in children; Ear - Other ear disorders; Infection - Other infectious diseases

• Registration Number: ACTRN12618000049279
• Lead Sponsor: Respati Wulansari Ranakusuma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-16
• Study Completion: 2019-02-19
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Children with acute otitis media, defined as a current onset within 48 to 72 hours of ear-related symptoms (e.g. ear pain, ear tugging/rubbing or irritability for non-verbal young children) and/or signs of acute inflammation (e.g. erythema ear drum) and middle ear effusion (e.g. bulding ear drum, air-fluid level, purulent appearance of ear drum) if feasible to assess using otoscope,

Exclusion Criteria

1. Children with major and severe medical conditions (e.g. heart failure, kidney failure)
2. Immunocompromised children (e.g. HIV, children receiving cancer treatment)
3. Children with congenital malformations and/or syndromes (e.g. cleft palate, Down’s syndrome)
4. Children with high risk of risk of strongyloidiasis infection
5. Children with ear ventilation tube(s)
6. Children who had exposed to persons with varicella (chicken pox) or active Zoster infection in the past 3 weeks without any prior varicella immunisation or infection
7. Children who have taken systemic (i.e. oral, injection) or topical steroids in the preceding four weeks
8. Children who have taken antibiotics in the preceding two weeks
9. Children who are hypersensitive to prednisolone or prednisone, or other corticosteroids.

Study & Design

• Study Type: Interventional
• Study Design: Not specified