FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/06/043015 [Registered on: 03/06/2022] Trial Registered Prospectively
Last Modified On: 03/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial To Compare The Effect Of Volume Guaranteed Ventilation Versus Pressure Controlled Ventilation In Preterm Infants With Respiratory Distress Syndrome 
Scientific Title of Study   VOLUME GUARANTEED VENTILATION VERSUS PRESSURE-CONTROLLED VENTILATION IN PRE TERM INFANTS WITH RESPIRATORY DISTRESS SYNDROME : A RANDOMIZED CONTROL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ghanshyam Saini 
Designation  Professor & Head 
Affiliation  Government Medical College Jammu  
Address  Government Medical College and Hospital maheshpura, chowk, Bakshi Nagar, Jammu, Jammu and Kashmir

Jammu
JAMMU & KASHMIR
180001
India 
Phone  9419193571  
Fax  0191-2584234  
Email  gs_saini63@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ghanshyam Saini 
Designation  Professor & Head 
Affiliation  Government Medical College Jammu  
Address  Government Medical College and Hospital maheshpura, chowk, Bakshi Nagar, Jammu, Jammu and Kashmir


JAMMU & KASHMIR
180001
India 
Phone  9419193571  
Fax  0191-2584234  
Email  gs_saini63@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Anuj Gupta 
Designation  Post Graduate 
Affiliation  Government Medical College Jammu  
Address  654- A Gandhinagar Jammu

Jammu
JAMMU & KASHMIR
180004
India 
Phone  9419288829  
Fax    
Email  anujrockstar0811@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatrics Government Medical College Jammu  
 
Primary Sponsor  
Name  Dr Ghanshyam Saini 
Address  Professor And Head , Department Of Pediatrics Government Medical College and Hospital maheshpura, chowk, Bakshi Nagar, Jammu, Jammu and Kashmir 180001 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Anumodan Gupta  maheshpura, chowk, Bakshi Nagar, Jammu, Jammu and Kashmir 180001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ghanshyam Saini  GMC Jammu   NICU-C , Department of Pediatrics
Jammu
JAMMU & KASHMIR 		 9419193571

gs_saini63@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Medical College, Jammu Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pressure controlled Ventilation  For the pressure controlled ventilation we will be using the SIMV+PC mode 
Intervention  Volume Guaranteed Ventilation  For the volume guaranteed ventilation we will be using the SIMV+VG(PRVC) mode 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  7.00 Day(s)
Gender  Both 
Details  1. Neonates born preterm between 27-34 weeks
2. Either gender.
3. Neonates developing RDS within first 7 days of life
4. Patients who would give written consent for the study. 
 
ExclusionCriteria 
Details  1. Neonates with:
a. Life threatening congenital
malformations
b. Air Leak Syndromes
c. Birth Asphyxia
d. Meconium Aspiration
e. Severe IVH
2. Parents not giving valid consent.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Total Duration of Mechanical Ventilation   Total Duration of Mechanical Ventilation during hospital stay 
 
Secondary Outcome  
Outcome  TimePoints 
1.Failure of primary treatment i.e clinical decision to change the mode of ventilation
2.incidence of the complications, such as air leaks, intraventricular hemorrhage (IVH), retinopathy of prematurity (ROP), and peri-ventricular leukomalacia(PVL) etc will also be studied. 		 During hospitalization 
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
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)   05/06/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Mechanical ventilation is primarily used because an infant is failing to breathe adequately, leading to CO2 retention. CO2 removal is determined by tidal volume (VT) and respiratory or ventilator rate. Volume ventilation (VTV) strategies aim to deliver a consistent VT. Advances in neonatal intensive care have resulted in increasing survival of very preterm and extremely preterm infants. Modern neonatal ventilation modes can target a set tidal volume as an alternative to traditional pressure‐limited ventilation (PLV) using a fixed inflation pressure. Volume‐guaranteed ventilation aims to produce a more stable tidal volume in order to reduce lung damage and stabilize the partial pressure of carbon dioxide (pCO2).
The VG mode also facilitates automatic weaning and as the patient lung compliance improves, the peak inspiratory pressure is automatically reduced to attain the set tidal volume


 
Close