| CTRI Number |
CTRI/2023/11/059483 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
31/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observervational study to predict if baby will require respiratory support at 28 days of life using lung ultrasound in babies born less than 32 weeks of gestational age |
|
Scientific Title of Study
|
A prospective observational study to predict the need of respiratory support at 28 days of life using point of care lung ultrasound in neonates less than 32 weeks of gestational age |
| 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 Vikrant Deshmukh |
| Designation |
DM Neonatology resident |
| Affiliation |
Bharati vidyapeeth deemed to be university medical college and hospital |
| Address |
Bharati Vidyapeeth deemed to be medical college and hospital, Pune-Satara Road, Katraj, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9096015474 |
| Fax |
|
| Email |
vikrant.deshmukh40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Surawanshi |
| Designation |
DM Neonatology |
| Affiliation |
Bharati vidyapeeth deemed to be university medical college and hospital |
| Address |
Bharati Vidyapeeth deemed to be medical college and hospital, Pune-Satara Road, Katraj, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9923540500 |
| Fax |
|
| Email |
drpradeepsuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikrant Deshmukh |
| Designation |
DM Neonatology resident |
| Affiliation |
Bharati vidyapeeth deemed to be university medical college and hospital |
| Address |
Bharati Vidyapeeth deemed to be medical college and hospital, Pune-Satara Road, Katraj, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9096015474 |
| Fax |
|
| Email |
vikrant.deshmukh40@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth deemed to be medical college and hospital, Pune |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Medical college |
| Address |
Bharati Vidyapeeth deemed to be medical college and hospital, 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 Vikrant Deshmukh |
Bharati vidyapeeth deemed to be university medical college and hospital, Pune |
Department of neonatology, second floor, old hospital building
Pune
MAHARASHTRA |
9096015474
vikrant.deshmukh40@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Medical college Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P271||Bronchopulmonary dysplasia originating in the perinatal period, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All newborns less than 32 weeks of gestational age will be recruited |
|
| ExclusionCriteria |
| Details |
1. Major congenital malformation (cyanotic congenital heart disease, suspected genetic disorders, structural diseases affecting lung function (congenital diaphragmatic hernia).
2. Suspected Inborn errors of metabolism
3. Extramural preterm babies admitted in the unit after 24 hours of birth
4. Suspected muscular dystrophy or neurological disease that may affect lung development or function |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To predict the need of respiratory support at 28 days of life using lung ultrasound score at 7 days of life in preterm neonates less than 32 weeks of gestational age |
7 & 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the association of the score on day 7 with the type of respiratory support required at 28 days of life |
7 & 28 days |
| To determine the association of the score on day 14 with the type of respiratory support required at 28 days of life |
14 & 28 days |
|
|
Target Sample Size
|
Total Sample Size="147"
Sample Size from India="147"
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)
|
11/11/2023 |
| 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="9"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Proposals should be directed to researcher via email (vikrant.deshmukh40@gmail.com)
- For how long will this data be available start date provided 28-08-2023 and end date provided 31-07-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective observational study is being taken up to predict the need of respiratory support at 28 days of life using point-of-care lung ultrasound scores in preterm neonates less than 32 weeks of gestational age. We hypothesize that since the LUS score reflects lung aeration, it will correlate with the need of respiratory support at 28 days of life. This can not only help in early prediction and intervention thus preventing respiratory morbidities but also in the counseling of parents about prognosis, financial burden, and follow-up respiratory care.
|