| CTRI Number |
CTRI/2024/06/068409 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A hospital-based study comparing the diagnostic accuracy of lung ultrasound with chest X-ray for respiratory distress in newborns admitted to the neonatal ICU. |
|
Scientific Title of Study
|
The diagnostic accuracy of lung ultrasound vs. chest X-ray for respiratory distress in neonates admitted to the neonatal intensive care unit: a hospital-based cross-sectional study. |
| 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. Tambuluru Sri Kavya |
| Designation |
Pediatric resident |
| Affiliation |
Jawarhal nehru medical college |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar,
KLE Hospital Road Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
6363215643 |
| Fax |
|
| Email |
kavyareddy9550@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata M Jali |
| Designation |
Professor |
| Affiliation |
Jawarhal nehru medical college |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar,
Belgaum
KARNATAKA
590010
India |
| Phone |
9845688999 |
| Fax |
|
| Email |
drsmjali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tambuluru Sri Kavya |
| Designation |
Pediatric resident |
| Affiliation |
Jawarhal nehru medical college |
| Address |
Department of paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar,
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
6363215643 |
| Fax |
|
| Email |
kavyareddy9550@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital
Jawaharlal Nehru Medical College, KLE University, Belagavi, 590010 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College KLE University Belagavi |
| Address |
Department of Pediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road, Belgaum, Karnataka, 590010. |
| 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 Tambuluru Sri Kavya |
KLEs Dr Prabhakar Kore Hospital Belagavi |
Department of paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital road, Belgaum.
Belgaum
KARNATAKA |
6363215643
kavyareddy9550@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J20-J22||Other acute lower respiratory infections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
The Diagnostic Accuracy of Lung Ultrasound and Chest X-Ray |
The Diagnostic Accuracy of Lung Ultrasound and Chest X-Ray in Preterm Neonates Admitted to Neonatal Intensive Care Unit for Respiratory Distress. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Month(s) |
| Age To |
9.00 Month(s) |
| Gender |
Both |
| Details |
Neonates with Gestational age of more than 24 weeks and less than 40 weeks with signs of Respiratory distress. |
|
| ExclusionCriteria |
| Details |
Neonates with pre-existing disease conditions other than Respiratory distress.
Neonates with chest deformity.
Neonates with Congenital anomalies/malformation.
Parents who refuse to give consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Diagnostic accuracy of Lung ultrasound and Chest X-ray in new born with respiratory distress. |
To compare the Diagnostic accuracy of Lung ultrasound and Chest X-ray in new born with respiratory distress, One year study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess if neonatal Lung ultrasound is a useful predictor of need for intubation over Chest X-ray. |
To assess if neonatal Lung ultrasound is a useful predictor of need for intubation over Chest X-ray, One year study. |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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)
|
15/06/2024 |
| 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="1"
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
|
|