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CTRI Number  CTRI/2017/11/010439 [Registered on: 09/11/2017] Trial Registered Retrospectively
Last Modified On: 18/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison between two ventilatory modes in reducing the days of mechanical ventilation and also assosciated complications. 
Scientific Title of Study   Volume-Targeted Ventilation versus Pressure–Limited Ventilation in Respiratory Distress Syndrome in Prematurely Born Infants- Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gokul krishna G 
Designation  Post Graduate student Respiratory Therapy 
Affiliation  kasturba medical college 
Address  Department of Respiratory Therapy, SOAHS Manipal
Department of Peadiatrics KMC, manipal
Udupi
KARNATAKA
576104
India 
Phone  9108598185  
Fax  0  
Email  gokulrescare@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Leslie lewis edward 
Designation  Professor and Head of NICU 
Affiliation  kasturba medical college 
Address  Department of Paediatrics KMC, manipal
Department of Respiratory Therapy, SOAHS Manipal
Udupi
KARNATAKA
576104
India 
Phone  9108598185  
Fax  0  
Email  leslielewis1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gokul krishna G 
Designation  Post Graduate student Respiratory Therapy 
Affiliation  kasturba medical college 
Address  Department of Respiratory Therapy, SOAHS Manipal
Department of Respiratory Therapy, SOAHS Manipal
Udupi
KARNATAKA
576104
India 
Phone  9108598185  
Fax  0  
Email  gokulrescare@gmail.com  
 
Source of Monetary or Material Support  
Department of Paediatrics, kasturba medical college, udupi, manipal 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
gokul krishna g  Kasturba hospital   Neonatal intensive care unit Department of Paediatrics
Udupi
KARNATAKA 
9108598185
0
gokulrescare@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
kmc and KH Institutional ethical committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Prematurely born newborns with Respiratory distress syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  pressure limited ventilation as the control group  comparison of two ventilatory modes in prematurely born respiratory distress syndrome 
Intervention  Volume targeted ventilation as the interventional group  comparison of two ventilatory modes in prematurely born newborns with respiratory distree syndrome 
 
Inclusion Criteria  
Age From  5.40 Month(s)
Age To  6.80 Month(s)
Gender  Both 
Details  1 Neonates with congenital cyanotic heart diseases.
2 Neonates with major congenital malformations.
3 Neonates with air leak syndromes.
4 Neonates requiring High Frequency Oscillatory Ventilation (HFOV)
 
 
ExclusionCriteria 
Details  1.Neonates with congenital cyanotic heart diseases.
2.Neonates with major congenital malformations.
3.Neonates with air leak syndromes.
4.Neonates requiring High Frequency Oscillatory Ventilation (HFOV)
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome is to compare the time required to reach the weaning criteria assessed by volume targeted ventilation to pressure limited ventilation in prematurely born infants.  At the time of extubation 
 
Secondary Outcome  
Outcome  TimePoints 
1 Rate of failure
2 Oxygenation Index at 6th hourly
3 FiO2 to SpO2 ratio
4 PaO2 to FiO2 ratio
5 Episodes of hypocarbia at 2nd hourly
6 Duration of mechanical ventilation
7 Oxygen radicals
8 Complications such as
9 Broncho pulmonary dysplasia(BPD)
10 Periventricular leukomalacia(PVL)
11 Air leak syndrome
12 Intraventricular Hemorrhage (IVH)
13 Retinopathy of Prematurity (ROP)
14 Mortality
 
at the time of extubation and at the time of discharge  
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "81"
Final Enrollment numbers achieved (India)="81" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/03/2016 
Date of Study Completion (India) 10/06/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Wheeler K, Klingenberg C,McCallion N,Morley CJ, Davis PG. Volume-targeted versus pressure-limited ventilation in the neonate. Cochrane Database of Systematic Reviews 2010, Issue 11 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Mechanical ventilation still remains as the mainstay of management in newborns with respiratory distress syndrome (RDS). The ventilated preterm infant lungs are vulnerable to overdistention and underinflation. Modern neonatal ventilators has volume targeted modes alternative to traditional pressure limited ventilation, which aims to deliver a more stable tidal volume thereby reducing volutrauma and atlectotrauma. OBJECTIVE: To determine whether volume targeted ventilation compared with pressure limited ventilation reduces the time to reach weaning criteria in prematurely born infants with RDS. METHOD: This is a randomized control trial of neonates who have been mechanically ventilated in NICU, Kasturba Hospital Manipal Udupi. Infants of less than 34 weeks with RDS requiring mechanical ventilation in first week of life were randomized to receive either pressure limited ventilation (PLV) or volume targeted ventilation (VTV). The primary outcome was the time to achieve prespecified weaning criteria. Secondary outcomes assessed was incidence of Pneumothorax, Retinopathy Of Prematurity (ROP), Intraventricular Haemorrhage (IVH), Necrotizing Enterocolitis (NEC), Periventricular leukomalacia (PVL) and  total ventilatory hours. RESULT: 81 neonates were enrolled and randomized into two treatment groups. The mean gestational age and birth weight of treatment group were 30 (±2.3) and 1230 (±374) gm and 70% of them received antenatal steroids. The primary outcome variable time to achieve weaning criteria was 8 hrs (3-17)(median and IQR) in PLV and 6 hrs (3- 13) in VTV (P=0.366), However in stratified analysis of infants in 31-34 weeks of GA there was a significant difference in primary outcomes, 10 hrs (5-14) in PLV and 5 hrs (2-12) in VTV (p=0.039). The complications associated with ventilation were compared and analysed between the groups.. CONCLUSION: In prematurely born infants with respiratory distress syndrome requiring mechanical ventilation, the use of VTV showed to be at par with the standard PLV. This could enable us to use it more confidently as a primary mode with lower limit of tidal volume. But in order to substantiate this further RCT may be required.

 
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