Corticosteroids as an Additional Treatment for Mastoiditis In Children

Mastoiditis; Acute Clinical Trial

— COSMIC  

Official title:

Corticosteroids as an Additional Treatment for Mastoiditis In Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04828525
• Other study ID #: 0702-20-RMC
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2021
• Source: Rabin Medical Center
• Contact: Ori Snapiri, Dr
• Phone: +972547242654
• Email: orisnapiri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

Inclusion Criteria:

• acute mastoiditis

Exclusion Criteria:

• immunodeficiency (congenital or acquired)

• significant chronic disease

• hypertension

• recurrent mastoiditis

Related Conditions & MeSH terms

• Mastoiditis
• Mastoiditis; Acute

Intervention

Drug:
• Dexamethasone
adjuvant dexamethasone treatment
• normal saline
placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ori snapiri

References & Publications (5)

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. Review. — View Citation

Brouwer MC, McIntyre P, Prasad K, van de Beek D. Corticosteroids for acute bacterial meningitis. Cochrane Database Syst Rev. 2015 Sep 12;(9):CD004405. doi: 10.1002/14651858.CD004405.pub5. Review. — View 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:CD012125. doi: 10.1002/14651858.CD012125.pub2. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of hospitalization	time from admission until discharge	anticipated 1-2 weeks
Primary	Time from the beginning of the treatment until clinical and laboratory findings are within normal limits	fever, crp levels	during hospitalization, anticipated 1-2 weeks
Secondary	Complication rates	sinus vein thrombosis, intracranial collection or abscess, need for surgery	during hospitalization, anticipated 1-2 weeks