| CTRI Number |
CTRI/2024/07/070042 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To estimate utility of 12 region lung ultrasound scan for diagnoses of pneumonia in neonates with respiratory distress |
|
Scientific Title of Study
|
A cross sectional study to estimate the proportion of cases diagnosed as pneumonia on 12 region lung ultrasound scan in neonates with respiratory distress |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Godi Anirudh |
| Designation |
DM, Senior Resident |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
Department of Neonatalogy, NICU division, 2nd floor, Bharati Hospital, Dhankawadi, Pune,
Pune
Maharashtra
411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7382597320 |
| Fax |
|
| Email |
anirudhreddygodi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sujata Deshpande |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
Department of Neonatology,
NICU division, 2nd floor, Bharati Hospital, Dhankawadi, Pune,
Pune
Maharashtra
411043
MAHARASHTRA
411043
India |
| Phone |
7382597320 |
| Fax |
|
| Email |
sujata.deshpande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Godi Anirudh |
| Designation |
DM, Senior Resident |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
Department of Neonataology, NICU division, 2nd floor, Bharati Hospital, Dhankawadi, Pune,
Maharashtra
411043
MAHARASHTRA
411043
India |
| Phone |
7382597320 |
| Fax |
|
| Email |
anirudhreddygodi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed University Medical College, Dhankawadi, Pune, Maharashtra, India
PIN-411043 |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Deemed University Medical College,Pune |
| Address |
NICU, Bharati Hospital, Dhankawadi, Pune |
| 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 Godi Anirudh |
Bharati Hospital |
Department of Neonatology, Division of NICU, 2ND floor, Bharati Hospital,Dhankawadi, Pune, Maharashtra, India-411043
Pune
MAHARASHTRA |
7382597320
anirudhreddygodi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed University Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates with respiratory distress
or
Neonates with deterioration of respiratory status |
|
| ExclusionCriteria |
| Details |
Neonates born through meconium stained amniotic fluid |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the proportion of cases diagnosed as pneumonia on 12 region lung ultrasound scan in neonates with respiratory distress or those having deterioration in respiratory status |
within 2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the proportion of cases diagnosed as pneumonia by using 12 region & 6 region lung ultrasound scan |
within 2 hours |
|
|
Target Sample Size
|
Total Sample Size="225"
Sample Size from India="225"
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)
|
15/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
To estimate the proportion of cases diagnosed as pneumonia on 12 region lung ultrasound scan in neonates with respiratory distress or those having deterioration in respiratory status within 2 hours of onset of respiratory distress or deterioration To compare the proportion of cases diagnosed as pneumonia by using 12 region and 6 region lung ultrasound scan |