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CTRI Number  CTRI/2025/06/088235 [Registered on: 04/06/2025] Trial Registered Prospectively
Last Modified On: 03/06/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of Ear Pulling behavior as a early sign of Acute Middle Ear Infection in infants below one year age. 
Scientific Title of Study   Evaluation of Ear Pulling/Tugging as a Screening Sign for Early Diagnosis of Acute Otitis Media in Infants below One Year 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shaishav Patel 
Designation  Assistant Professor, MD Pediatrics 
Affiliation  Ananya College of Medicine and Research 
Address  Room No.8, Department of Pediatrics, Adarsh Multispeciality Hospital, Ananya College of Medicine and Research, Kalol Institute and Research Center, Pratap Pura Village, Kalol, Gandhinagar, Gujarat 382721

Gandhinagar
GUJARAT
382721
India 
Phone  9428603871  
Fax    
Email  pshaishav246@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mukundkumar Patel 
Designation  Professor, MD Medicine 
Affiliation  Ananya College of Medicine and Research 
Address  Room No.6, Department of Medicine, Adarsh Multispeciality Hospital, Ananya College of Medicine and Research, Kalol Institute and Research Center, Pratap Pura Village, Kalol, Gandhinagar, Gujarat 382721

Gandhinagar
GUJARAT
382721
India 
Phone  09909013760  
Fax    
Email  mukundvp69@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mukundkumar Patel 
Designation  Professor, MD Medicine 
Affiliation  Ananya College of Medicine and Research 
Address  Room No.6, Department of Medicine, Adarsh Multispeciality Hospital, Ananya College of Medicine and Research, Kalol Institute and Research Center, Pratap Pura Village, Kalol, Gandhinagar, Gujarat 382721

Gandhinagar
GUJARAT
382721
India 
Phone  09909013760  
Fax    
Email  mukundvp69@gmail.com  
 
Source of Monetary or Material Support  
Ananya College of Medicine and Research 
 
Primary Sponsor  
Name  Dr Mukundkumar Patel 
Address  Ananya College of Medicine and Research, Adarsh Multispeciality Hospital, Kalol Institute and Research Center, Pratap Pura Village, Kalol, Gandhinagar, Gujarat 382721 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mukundkumar Patel  Ananya College of Medicine and Research  Ananya College of Medicine and Research, Adarsh Multispeciality Hospital, Kalol Institute and Research Center, Pratap Pura Village, Kalol, Gandhinagar, Gujarat 382721
Gandhinagar
GUJARAT 
09909013760

mukundvp69@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ananya Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H660||Acute suppurative otitis media,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  12.00 Month(s)
Gender  Both 
Details 
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).
 
 
ExclusionCriteria 
Details  1. Known congenital ear anomalies.
2. History of chronic otitis media or prior ear surgery.
3. Infants with systemic infections involving multiple organs.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Sensitivity, specificity, positive predictive value, and negative predictive value of ear pulling as a screening sign for Acute Otitis Media  six weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Acute otitis media (AOM) is a prevalent pediatric condition characterized by middle ear inflammation, often associated with effusion. It primarily affects infants and young children and is a leading cause of physician visits, antibiotic prescriptions, and potential complications if left untreated. Early diagnosis in infants is particularly challenging as they cannot verbalize their symptoms, and clinical presentations such as fever, irritability, and feeding difficulties are nonspecific. Parental observation of ear pulling or tugging has been noted anecdotally as a potential indicator of ear discomfort and AOM. However, there is limited data on its diagnostic accuracy. Investigating the utility of ear pulling as a screening sign could aid in early identification and timely management of AOM, reducing the risk of complications and unnecessary antibiotic use.

This study aims to evaluate the sensitivity, specificity, and predictive values of ear pulling in diagnosing AOM, correlating it with definitive otoscopic findings.

Main Objectives of study are to  assess the 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 as ear tugging, rubbing, or crying when touching the ear. An Otorhinolaryngologist will perform otologic examinations using pneumatic otoscopy to confirm the diagnosis of AOM. A standardized case record 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 the association 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 of Helsinki, will be followed throughout the study.  Expected benefits to volunteers are there in this study as volunteers will be diagnosed timely and treated timely which is very beneficial for their own health.


 
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