Outcomes and Prognostic Factors of Acute Mastoiditis in the Grand-Est Region

NCT07122440 | Completed

• 1 other identifier: 2023PI213
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 1

Brief Summary

There is an increased incidence of acute mastoïditis and a lack of homogeneity in management. The investigator aim to refine the epidemiological knowledge on this pathology. Data of children with acute mastoiditis of the last ten years in five hospitals of the North-East of France (University Hospitals of Nancy, Strasbourg, Dijon, Besançon and the Regional Hospital of Metz-Thionville) will be analyzed.

Conditions

Acute Mastoiditis

Keywords

acute mastoiditis; prognostic; mastoiditis complications

Outcome Measures

Primary Outcomes (1)

• Prognostic factors of recovery in children hospitalized for mastoiditis in the region Grand-Est of France between 2014 and 2024

  The primary outcome was recovery by Day 5, i.e., recovery on the fifth day of hospitalization. Recovery was a composite outcome based on three subcriteria: * (i) absence of fever (body temperature ≥ 38°C); * AND (ii) absence of neutrophilia (neutrophil count \> 8.5 G/L); * AND (iii) absence of local symptoms (i.e., otalgia or ear inflammation). Patients presenting with fever OR neutrophilia OR local clinical symptoms on Day 5 or later were classified as not recovered by Day 5. Fever and local symptoms are monitored by the nursing staff several times a day during the hospitalization. The neutrophil count is measured as part of the laboratory test, performed on the day of hospital admission, and carried out multiple times during hospitalizations. The absence of follow-up laboratory testing suggests clinical improvement. The abovementioned outcomes were extracted, as well as variables known or suspected to be associated with mastoiditis recovery or complications.

  From January 2014 to July 2024

Secondary Outcomes (2)

• Evolution of complication rate of mastoiditis between January 2014 and July 2024

  From January 2014 to July 2024

• Factors associated with complicated acute mastoïditis

  From January 2014 to July 2024

Interventions

acute mastoiditis OTHER

retrospective data collection from clinical charts

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Cf Eligibility criteria

You may qualify if:

• All patients under 15 years of age
• Supported in one of the ENT or pediatric services of the four investigation centers
• Between January 1, 2014 and July 31, 2024
• With a diagnosis of acute mastoiditis

You may not qualify if:

• Patient with history of cholesteatoma or cochlear implantation

Sponsors & Collaborators

• Cécile RUMEAU: lead

Study Sites (1)

University Hospital Center of Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Otolaryngology

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: August 14, 2025
• Study Start: March 2, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)