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Clinical Trial Summary

The aim of the study is to assess the influence of adjuvant corticosteroid treatment in acute mastoiditis in children. we expect a better outcome in children treated with both corticosteroids and antibiotics including lower rates in complications and earlier decline in fever and inflammatory markers.


Clinical Trial Description

The research is a multi-centered, prospective, placebo-control, randomized controlled trial. The study group will be comprised of children diagnosed with acute mastoiditis and hospitalized in a pediatric medical center. The participating patients will be randomized divided into two groups. Research group will be given dexamethasone treatment (course of 16 doses, 0.15 mg/kg/dose every 6 hours) in addition to antibiotic treatment. Control group will be given 16 doses of 0.9% normal saline in addition to antibiotic treatment. Management and treatment will be conducted according to clinical condition and laboratory findings as for routine institution protocols. It should be noted that the regular institutional management of children enrolled for the study will not be changed due to our research. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04828525
Study type Interventional
Source Rabin Medical Center
Contact Ori Snapiri, Dr
Phone +972547242654
Email orisnapiri@gmail.com
Status Not yet recruiting
Phase Phase 3
Start date April 1, 2021
Completion date July 31, 2024