Clinical trial NCT04828525: Corticosteroids as an Additional Treatment for Mastoiditis In Children
Official title: Corticosteroids as an Additional Treatment for Mastoiditis In Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Mastoiditis; Acute
Keywords: mastoiditis
children
corticosteroids
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research is a multi-centered, prospective, placebo-control, randomized controlled trial.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* acute mastoiditis

Exclusion Criteria:

* immunodeficiency (congenital or acquired)
* significant chronic disease
* hypertension
* recurrent mastoiditis

Primary outcomes:
measure: Time from the beginning of the treatment until clinical and laboratory findings are within normal limits
timeFrame: during hospitalization, anticipated 1-2 weeks
Secondary outcomes:
measure: Complication rates
timeFrame: during hospitalization, anticipated 1-2 weeks
Other outcomes:
measure: Duration of hospitalization
timeFrame: anticipated 1-2 weeks
Locations:
Study officials:
References:
citation: Lin HW, Shargorodsky J, Gopen Q. Clinical strategies for the management of acute mastoiditis in the pediatric population. Clin Pediatr (Phila). 2010 Feb;49(2):110-5. doi: 10.1177/0009922809344349. Epub 2009 Sep 4.
citation: Groth A, Enoksson F, Hultcrantz M, Stalfors J, Stenfeldt K, Hermansson A. Acute mastoiditis in children aged 0-16 years--a national study of 678 cases in Sweden comparing different age groups. Int J Pediatr Otorhinolaryngol. 2012 Oct;76(10):1494-500. doi: 10.1016/j.ijporl.2012.07.002. Epub 2012 Jul 23.
citation: Delgado-Noguera MF, Forero Delgadillo JM, Franco AA, Vazquez JC, Calvache JA. Corticosteroids for septic arthritis in children. Cochrane Database Syst Rev. 2018 Nov 21;11(11):CD012125. doi: 10.1002/14651858.CD012125.pub2.
citation: Aljebab F, Choonara I, Conroy S. Systematic review of the toxicity of short-course oral corticosteroids in children. Arch Dis Child. 2016 Apr;101(4):365-70. doi: 10.1136/archdischild-2015-309522. Epub 2016 Jan 14.
citation: Brouwer MC, McIntyre P, Prasad K, van de Beek D. Corticosteroids for acute bacterial meningitis. Cochrane Database Syst Rev. 2015 Sep 12;2015(9):CD004405. doi: 10.1002/14651858.CD004405.pub5.