跳至主要内容
临床试验/NCT02779907
NCT02779907Unknown不适用

Prevalence and Associations of Paediatric Chronic Suppurative Otitis Media and Hearing Impairment in a Rural District of Malawi: A Cross-sectional Survey

Liverpool School of Tropical Medicine1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
270
试验地点
1
主要终点
Chronic Suppurative Otitis Media

研究概览

简要总结

This community-based cross-sectional survey will estimate the frequency and risk factors of Chronic Suppurative Otitis Media and Hearing Impairment in Children ages 4-6 years in the Chikwawa District. These data will be useful for service planning, disease prevention efforts and to guide future research in this field.

详细描述

Type of research study:

Cross sectional survey

Problem to be studied:

Chronic suppurative otitis media and hearing impairment are important causes of morbidity, affecting 4-10% of children throughout sub-Saharan Africa. Many of the causes of disease are preventable with simple interventions. There is significant variation in disease burden and causes between countries, and currently no data on the frequency and causes of disease in Malawi.

Previous studies suggest poverty, crowding, paternal smoking and indoor cooking all increase the risk of developing chronic suppurative otitis media. The associations with use of an efficient cookstove have not been studied. The causes of childhood hearing impairment vary significantly by region and include otitis, other infections and cryptogenic causes.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child aged 4-6 years old
  • Resident in the CAPS study area in the Chikwawa district of southern Malawi
  • Parental consent and child's assent to inclusion in the study

排除标准

  • Parent/guardian of participant unable to provide informed consent to their child's participation
  • Participant refusal to assent to participation
  • Participant unable to explicitly assent to involvement in the study (e.g. developmental delay, learning difficulties, unwell)

结局指标

主要结局

Chronic Suppurative Otitis Media

时间窗: Day1; This is a Cross-Sectional Survey and each participant will be assessed once. Therefore the outcome will be measured at data collection.

Chronic Suppurative Otitis Media will be defined as per the the World Health Organisation ear and hearing survey diagnostic criteria. To assign a diagnosis, tympanic membrane images and clinical data for each participant will be reviewed by two ENT surgeons who will assign a diagnosis. Disagreements will be resolved by a third 'tiebreaker'.

次要结局

  • Hearing Impairment at more than 25 decibels hearing loss cutoff at 1000Hz, 2000Hz and 4000Hz(Day 1; This is a Cross-Sectional Survey and each participant will be assessed once. Therefore the outcome will be measured at data collection.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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