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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  
Name  Address 
nil   
 
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  
Status 
Not Applicable 
 
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 ‐left ventricle.Increased end ‐diastolic LVEI would indicate volume overload as in hemodynamically significant PDA and increased end‐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

 
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