Évaluation Des Facteurs Pronostiques et de l'évolution Des mastoïdites aigües Dans la région Grand-Est
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Prognostic factors of recovery in children hospitalized for mastoiditis in the region Grand-Est of France between 2014 and 2024
研究概览
简要总结
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.
详细描述
Acute mastoiditis is a bacterial infection of the middle ear cavities, associated with destructive damage of the mastoid bone, complicating acute otitis media. It affects infants and young children and its complications can be serious, including neurological sequelae.
These complications can be divided into two categories according to their topography:
- intracranial complications : thrombophlebitis, meningitis, epidural abscess, and cerebral empyema.
- Extracranial complications subperiosteal abscess, Bezold's abscess, peripheral facial paralysis, labyrinthitis, and temporomandibular joint arthritis.
Incidence ranges from 1.2 to 6 per 100,000 children per year, with a trend of increasing cases with the increase in the proportion of Fusobacterium Necrophorum infections, described as frequent provider of complications. This observation is shared by the ENT practitioners of the CHRU of Nancy.
The management of mastoiditis is medico-surgical, but the therapeutic algorithms vary according to the centers and countries. The exact place of surgery is discussed in uncomplicated cases, despite recent meta-analyses. In France, no therapeutic algorithm is currently proposed by ENT societies.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient with history of cholesteatoma or cochlear implantation
结局指标
主要结局
Prognostic factors of recovery in children hospitalized for mastoiditis in the region Grand-Est of France between 2014 and 2024
时间窗: From January 2014 to July 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.
次要结局
- 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)
研究者
Cécile RUMEAU
Head of Otolaryngology
Central Hospital, Nancy, France