| CTRI Number |
CTRI/2024/05/067366 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Combining lung ultrasound score & Left ventricular eccentricity index in predicting readiness for extubation in RDS: A prospective cohort study |
|
Scientific Title of Study
|
Combination of Lung ultrasound score & Left ventricular eccentricity index in predicting extubation readiness in RDS: A prospective cohort 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 |
John Biswas |
| Designation |
Senior resident |
| Affiliation |
Government medical college Chh. Sambhajinagar |
| Address |
Department of neonatology
Government medical college
Chh.Sambhajinagar
Aurangabad MAHARASHTRA 431001 India |
| Phone |
9532102045 |
| Fax |
|
| Email |
biswas.j.91@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Laxmikant Deshmukh |
| Designation |
Professor and Head |
| Affiliation |
Government medical college Chh. Sambhajinagar |
| Address |
Department of neonatology
Government medical college
Chh.Sambhajinagar
Aurangabad MAHARASHTRA 431001 India |
| Phone |
9822478275 |
| Fax |
|
| Email |
deshmukhls@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Laxmikant Deshmukh |
| Designation |
Professor and Head |
| Affiliation |
Government medical college Chh. Sambhajinagar |
| Address |
Department of neonatology
Government medical college
Chh.Sambhajinagar
Aurangabad MAHARASHTRA 431001 India |
| Phone |
9822478275 |
| Fax |
|
| Email |
deshmukhls@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of neonatology
Government medical college, Chh. Sambhajinagar
Maharashtra-431001
India |
|
|
Primary Sponsor
|
| Name |
Government medical college, Chh Sambhajinagar |
| Address |
Department of neonatology
Government medical college
Chh. Sambhajinagar- 431001
|
| Type of Sponsor |
Government 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 John Biswas |
Government medical college Chh.Sambhajinagar |
Department of neonatology
Government medical college
Chh. Sambhajinagar Aurangabad MAHARASHTRA |
9532102045
biswas.j.91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe government medical college Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
All babies of GA less than 37 weeks with diagnosis of RDS requiring intubation for initial stabilisation and requirement for mechanical ventilation for more than 72 hours |
|
| ExclusionCriteria |
| Details |
1. Major congenital anomalies
2. Perinatal asphyxia
3. IVH more than grade II
4. Hemodynamic instability requiring 2 or more inotropes with poor sensorium
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess whether LUS scores at day 3 and day7 of life can predict the success of extubation trials in mechanically ventilated preterm infants with RDS requiring prolonged ventilation |
To assess whether LUS scores at day 3 and day7 of life can predict the success of extubation trials in mechanically ventilated preterm infants with RDS requiring prolonged ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the correlations of LVEI with pulmonary artery pressures and patent ductus arteriosus. |
Day3 and day7 |
|
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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)
|
15/05/2024 |
| 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 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
|
Pulmonary hypertension in newborns (PPHN) is
triggered by multiple etiologies including hypoxemia and underlying parenchymal
lung diseases and can potentially hinder extubation. Performing a full
echocardiographic studies on all mechanically ventilated preterm infants would
be exhaustive and may not consistently correlate with PPHN.
LVEI is a quantifiable
measure of the amount of distortion of ventricular septal geometry due to
elevated right ventricular systolic or diastolic pressures and/or volumes.
Greater degrees of LVEI have been associated with PPHN in children and adults,
but have not been studied thoroughly in premature infants. LVEI has the added
benefit of being easily measured from any short axis view of the mid â€left
ventricle.Increased end â€diastolic LVEI would indicate volume overload as in
hemodynamically significant PDA and increased endâ€systolic LVEI may indicate
right ventricular volume overload as in PPHN,.The aim of the study is to find correlation betweeen lung ultrasound score and left ventricular eccentricity index in predicting extubation readiness in preterm neonates with RDS |