Evaluation of Ear Pulling/Tugging as a Screening Sign for Early Diagnosis of Acute Otitis Media in Infants below One Year
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1.Sensitivity, specificity, positive predictive value, and negative predictive value of ear pulling as a screening sign for Acute Otitis Media
研究概览
简要总结
Acute otitis media (AOM) is a prevalent pediatric conditioncharacterized by middle ear inflammation, often associated with effusion. Itprimarily affects infants and young children and is a leading cause ofphysician visits, antibiotic prescriptions, and potential complications if leftuntreated. Early diagnosis in infants is particularly challenging as theycannot verbalize their symptoms, and clinical presentations such as fever,irritability, and feeding difficulties are nonspecific. Parental observation of ear pulling or tugging has beennoted anecdotally as a potential indicator of ear discomfort and AOM. However,there is limited data on its diagnostic accuracy. Investigating the utility ofear pulling as a screening sign could aid in early identification and timelymanagement of AOM, reducing the risk of complications and unnecessaryantibiotic use.
This study aims to evaluate the sensitivity, specificity,and predictive values of ear pulling in diagnosing AOM, correlating it withdefinitive otoscopic findings.
Main Objectives of study are to assessthe correlation between ear tugging and Acute Otitis Media, to evaluate sensitivity and specificity of ear pulling as a screening tool and to improve early diagnosis and intervention.
In this study, Infants presenting with fever, irritability, or unexplained crying will be screened for ear-pulling behavior. Parents will report observed behaviors such asear tugging, rubbing, or crying when touching the ear. AnOtorhinolaryngologist will perform otologic examinations usingpneumatic otoscopy to confirm the diagnosis of AOM. A standardized caserecord form (CRF) will be used to document demographic data, clinical history,parental observations, otoscopic findings, and final diagnosis. Statistical analysis will be done in form of Descriptive statistics for demographic and clinical data, Diagnostic metrics (sensitivity, specificity, PPV, NPV) for ear pulling and Chi-square or Fisher’s exact test to assess theassociation between ear pulling and confirmed AOM cases.
Informed consent will be obtained from all parents or guardians, The study involves minimal risk as it relies on standard clinical examinations, Data confidentiality will be strictly maintained.
Ethical guidelines, including the Declaration ofHelsinki, will be followed throughout the study.Expected benefits to volunteers are there in this study as volunteers will bediagnosed timely and treated timely which is very beneficial for their ownhealth.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Month(s) 至 12.00 Month(s)(—)
- 性别
- All
入选标准
- •1.Presenting with fever more than or equal to 38 degree Celcius, irritability, or unexplained crying.
- •2.Consent obtained from parent(s) or guardian(s).
排除标准
- •1.Known congenital ear anomalies.
- •2.History of chronic otitis media or prior ear surgery.
- •3.Infants with systemic infections involving multiple organs.
结局指标
主要结局
1.Sensitivity, specificity, positive predictive value, and negative predictive value of ear pulling as a screening sign for Acute Otitis Media
时间窗: six weeks
次要结局
未报告次要终点
