| CTRI Number |
CTRI/2026/04/108144 [Registered on: 10/04/2026] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Diagnostic accuracy of lung ultrasound compared to chest X-ray in children hospitalized with community acquired pneumonia. |
|
Scientific Title of Study
|
Diagnostic Accuracy of Lung Ultrasound versus Chest X ray for Lower Respiratory Tract Infection in Hospitalised Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raksha Kumbhare |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi Meghe Wardha |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Sawangi Meghe
Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
08928116116 |
| Fax |
|
| Email |
rakshakumbhare@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Amar Taksande |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi Meghe Wardha |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Sawangi Meghe
Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9822369233 |
| Fax |
|
| Email |
amar.taksande@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Raksha Kumbhare |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi Meghe Wardha |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Sawangi Meghe
Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
08928116116 |
| Fax |
|
| Email |
rakshakumbhare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College Sawangi Meghe, Wardha, 442001 |
|
|
Primary Sponsor
|
| Name |
JNMC |
| Address |
Sawangi Meghe, Wardha, Maharashtra, India, 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Raksha Kumbhare |
Jawaharlal Nehru Medical College |
Department of Paediatrics, Jawaharlal Nehru Medical College, Sawangi Meghe Wardha MAHARASHTRA |
08928116116
rakshakumbhare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1 month to 18 years admitted with signs and symptoms suggestive of community acquired pneumonia such as fever cough tachypnea chest indrawing or respiratory distress. Informed consent obtained from parents or legal guardians. |
|
| ExclusionCriteria |
| Details |
Hospital acquired pneumonia.
Known chronic lung diseases such as bronchiectasis or cystic fibrosis.
Hemodynamically unstable patients not fit for imaging.
Patients with incomplete clinical or imaging data. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic accuracy (sensitivity and specificity) of lung ultrasonography for diagnosing community acquired pneumonia in hospitalised children compared with the final clinical diagnosis (WHO Criteria and follow-up). |
Within 24 hrs of admission and confirmation and discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of lung ultrasound and chest X ray findings |
At admission |
| Agreement between lung ultrasound and chest X ray |
During hospital admission |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
22/04/2026 |
| 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="2" Months="0" 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
|
Community acquired pneumonia is one of the leading causes of morbidity and mortality among children worldwide particularly in low and middle income countries. Early and accurate diagnosis is important for prompt treatment and prevention of complications. Chest radiography has traditionally been used as the standard imaging modality for diagnosis of pneumonia but it exposes children to ionizing radiation and may not always be readily available. Lung ultrasound is a bedside imaging modality which is non invasive radiation free and can be performed repeatedly without harm. Recent studies suggest that lung ultrasound has good diagnostic accuracy for detecting pneumonia in children.
This study aims to evaluate the diagnostic accuracy of lung ultrasound compared with chest radiography in hospitalized children with clinically suspected community acquired pneumonia. Children aged one month to eighteen years presenting with symptoms suggestive of pneumonia will be enrolled after obtaining informed consent from parents or guardians. Each child will undergo both lung ultrasound and chest radiography. The sensitivity specificity positive predictive value and negative predictive value of lung ultrasound will be calculated and compared with chest radiography and clinical diagnosis. The findings of this study may help determine the usefulness of lung ultrasound as a bedside diagnostic tool in pediatric pneumonia. |