| 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
|
|
|
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
|
|
|
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.
|