A Phase 3 interventional study of Dexamethasone and normal saline in Mastoiditis; Acute, sponsored by ori snapiri. Status unknown. Open to participants aged 6 Months to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-06.
Sponsored by ori snapiri · Phase 3, Interventional, and Treatment
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.
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.
This is the only study on the registry with ori snapiri as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
participants will be given corticosteroids in addition to conventional treatment
Drug: Dexamethasone
participants will be given normal saline in addition to conventional treatment
Drug: normal saline
adjuvant dexamethasone treatment
placebo
Time from the beginning of the treatment until clinical and laboratory findings are within normal limits
fever, crp levels
Time frame: during hospitalization, anticipated 1-2 weeks
Complication rates
sinus vein thrombosis, intracranial collection or abscess, need for surgery
Time frame: during hospitalization, anticipated 1-2 weeks
Duration of hospitalization
time from admission until discharge
Time frame: anticipated 1-2 weeks
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Mastoiditis