| CTRI Number |
CTRI/2024/09/073455 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Vibrating machine breathing support with additional gas in small babies. |
|
Scientific Title of Study
|
High-frequency Oscillatory Ventilation with or without Volume Guarantee in Neonates: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| No. 318/IEC/PGM/2024, Version 1, dated 09/08/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sriparna Basu |
| Designation |
Professor & Head, Department of Neonatology |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room No.016123, Block A, Medical College Building, Department of
Neonatology, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9935340260 |
| Fax |
|
| Email |
sriparna.neonat@aiimsrishikesh.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Siddhavatam Rahul Karthik |
| Designation |
Academic Junior Resident (MD Pediatrics) |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room No.016121, Block A, Medical College Building, Department of
Neonatology, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9121490270 |
| Fax |
|
| Email |
rahulkarthik281@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sriparna Basu |
| Designation |
Professor & Head, Department of Neonatology |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room No.016123, Block A, Medical College Building, Department of
Neonatology, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9935340260 |
| Fax |
|
| Email |
sriparna.neonat@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Rishikesh |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
All India Institute of Medical Sciences, Rishikesh Virbhadra
Road,Pashulok, District - Dehradun, Uttaranchal - 249203 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sriparna Basu |
Room No.016113, Block A, Medical College
Building, Department of Pediatrics, All India
Institute of Medical Sciences, Rishikesh
Dehradun, UTTARANCHAL 249203, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sriparna Basu |
All India Institute of Medical Sciences, Rishikesh |
Neonatal Intensive
Care Unit, Level 3, B
Block, Hospital
Building, Department of
Neonatology All India
Institute of Medical
Sciences, Rishikesh
Dehradun
UTTARANCHAL - 249203
Dehradun
UTTARANCHAL |
9935340260
sriparna.neonat@aiimsrishikesh.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P229||Respiratory distress of newborn, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
High-frequency oscillatory ventilation alone |
Once recruited, neonates will be started on high-frequency oscillatory ventilation without volume guarantee. An initial amplitude will be set at twice the value of mean airway pressure. The amplitude will be adjusted based on wiggles observed over the lower abdomen (near the umbilicus) and targeting the measured high-frequency tidal volume (VThf) of 2 mL/kg. Subsequently, the amplitude will be titrated to result in a change in VThf of no more than 0.5 mL/kg at a time to keep the pCO2 in the pre-defined target range. Routine modifications will be done at 1, 6, and 24 hours and subsequently as and when necessary. |
| Intervention |
High-frequency oscillatory ventilation with volume guarantee |
Once recruited, neonates will be started on high-frequency oscillatory ventilation along with volume guarantee. The initial high-frequency tidal volume (VThf) will be set 2 mL/kg. The amplitude limit will be 10-20% higher than the average amplitude delivered to achieve the desired VThf. Subsequently, VThf will be titrated by no more than 0.5 mL/kg at a time to keep the pCO2 in the pre-defined target range. Routine modifications will be done at 1, 6, and 24 hours and subsequently as and when necessary. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
3.00 Month(s) |
| Gender |
Both |
| Details |
Neonates who fail conventional mechanical ventilation and require high-frequency oscillatory ventilation as a rescue mode. CMV failure will be defined as the presence of any of the following
1. Peak positive pressure more than 26 cm H2O
2. Mean airway pressure more than 12 cm H2O
3. Diffuse atelectasis in chest x-ray requiring lung recruitment
4. Refractory respiratory acidosis defined as pCO2 more than 60 mmHg and or pH less than 7.20
5. Air leak syndrome in conventional mechanical ventilation
|
|
| ExclusionCriteria |
| Details |
Major congenital malformations |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypo or hypercarbia at 1 hour after starting high frequency oscillatory ventilation |
At 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of hypo or hypercarbia at 6, and 24 hours after starting HFOV
2. Any incidence of hypo or hypercarbia during HFOV
3. Total number of episodes of hypo or hypercarbia during HFOV
4. Measured high frequency tidal volume at 1, 6, 12, 24 and 48 hours as applicable
5. Cranial USG and cerebral blood flow in the anterior cerebral artery at baseline and one hour of HFOV
6. Regional cerebral oxygenation at baseline and one hour of HFOV
7. Duration of invasive mechanical ventilation
8. Duration of respiratory support in any form
9. Incidences of morbidities during hospital stay
10. Mortality
11. Duration of hospital stay
|
During hospital stay |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
16/09/2024 |
| 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="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sriparna.neonat@aiimsrishikesh.edu.in].
- For how long will this data be available start date provided 01-07-2026 and end date provided 30-06-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Research question: In neonates failing
conventional mechanical ventilation and requiring high-frequency oscillatory
ventilation as a rescue mode (P), does the addition of volume guarantee
with HFOV (I) compared to HFOV alone (C) reduce the incidences of
hypo or hypercarbia (O)? Research hypothesis: In neonates failing CMV and requiring HFOV as a rescue
mode, the addition of VG with HFOV will reduce the incidences of hypo or
hypercarbia. Aim of
the study: To determine the efficacy of HFOV with VG in neonates failing CMV and
requiring HFOV as a rescue mode. |