NCT04828525

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2021

Typical duration for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

3 years

First QC Date

March 30, 2021

Last Update Submit

April 4, 2021

Conditions

Mastoiditis; Acute

Keywords

mastoiditischildrencorticosteroids

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Complication rates

    during hospitalization, anticipated 1-2 weeks

Other Outcomes (1)

  • Duration of hospitalization

    anticipated 1-2 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

participants will be given corticosteroids in addition to conventional treatment

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

participants will be given normal saline in addition to conventional treatment

Drug: normal saline

Interventions

DexamethasoneDRUG

adjuvant dexamethasone treatment

Experimental
normal salineDRUG

placebo

Placebo

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • acute mastoiditis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 19734439BACKGROUND

  • 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.

    PMID: 22832239BACKGROUND

  • 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.

    PMID: 30480764BACKGROUND

  • 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.

    PMID: 26768830BACKGROUND

  • 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.

    PMID: 26362566BACKGROUND

MeSH Terms

Conditions

Mastoiditis

Interventions

DexamethasoneSaline Solution

Condition Hierarchy (Ancestors)

OsteomyelitisBone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal DiseasesOtitis MediaOtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Ori Snapiri, Dr

CONTACT

+972547242654orisnapiri@gmail.com

Chen Rosenberg Danziger, Dr

CONTACT

+972-3-925 3775chen.danziger@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
participants will be randomized divided into two groups. each group will be given dexamethasone or 0.9% normal saline. only the pharmacist will not be masked to the procedure.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The research is a multi-centered, prospective, placebo-control, randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Pediatrician, Principal Investigator, Clinical doctor

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 2, 2021

Study Start

April 1, 2021

Primary Completion

March 31, 2024

Study Completion

July 31, 2024

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share