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
|
|
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
|
|
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. |