| CTRI Number |
CTRI/2024/02/063010 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Testing the effectiveness of a method of breathing support for treating infection of the lungs in children admitted in children’s Intensive Care Unit. |
|
Scientific Title of Study
|
Low-Cost Bubble Continuous Positive Airway Pressure (CPAP) In Indian Tertiary PICU -A Mixed Method Feasibility 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 |
Dr M R Savitha |
| Designation |
Professor and Head of the department |
| Affiliation |
Mysore Medical College and Research Institute, Mysore |
| Address |
Department of Paediatrics
Mysore Medical College and Research Institute,
Mysore, Karnataka, India
Mysore KARNATAKA 570001 India |
| Phone |
7204533071 |
| Fax |
|
| Email |
drsavithamr@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr M R Savitha |
| Designation |
Professor and Head of the department |
| Affiliation |
Mysore Medical College and Research Institute, Mysore |
| Address |
Department of Paediatrics
Mysore Medical College and Research Institute,
Mysore, Karnataka, India
Mysore KARNATAKA 570001 India |
| Phone |
7204533071 |
| Fax |
|
| Email |
drsavithamr@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shalini S R |
| Designation |
Assistant Professor |
| Affiliation |
Mysore Medical College and Research Institute, Mysore, Karnataka, India |
| Address |
Dept of Pediatrics,
Mysore Medical College and Research Institute,
Mysore, Karnataka, India
Mysore KARNATAKA 570001 India |
| Phone |
9483608688 |
| Fax |
|
| Email |
shalinimmcri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Paediatric Intensive Care Unit (PICU) Department Of Paediatrics,
Cheluvamba Hospital, Mysore Medical College and Research Institute , Mysore , Karnataka , India
The Vayu Global Health Foundation , 22 Welgate Road, Medfort, MA 02155 |
|
|
Primary Sponsor
|
| Name |
Mysore Medical College and Research Institute Mysore |
| Address |
Paediatric Intensive Care Unit (PICU) Department Of Paediatrics , Cheluvamba Hospital , Mysore Medical College and Research Institute , Mysore , Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Nagendra K |
Associate Professor
Dept of Pediatrics
Mysore Medical College and Research Institute,
Mysore.India |
| Dr Raj Prakash |
Paediatrics and Neonatal Speciality Doctor,York and Scarborough
Teaching Hospitals NHS Foundation Trust, Wigginton Rd, Clifton,
York YO31 8HE |
| Dr Shalini SR |
Assistant Professor, Department of Paediatrics, Mysore Medical CollegeandResearchInstitute, Mysore, India |
| Prof Thomas F Burke |
Professor, Harvard Medical School Professor, Harvard TH Chan
School of Public Health,Mass General Emergency Medicine 55 Fruit
St.
Boston, MA 02115 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shalini S R |
Paediatric intensive care unit |
Room no 4,
PICU,
Department of paediatrics,
Cheluvamba Hospital,
Mysore medical College and research Institute ,Mysore 570001 Mysore KARNATAKA |
9483608688
shalinimmcri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mysore medical college Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J189||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low cost bubble continuous positive air way pressure device ( Vayu b CPAP) |
The novel low-cost Vayu bubble CPAP device developed by Vayu global health innovations, Boston, Massachusetts, integrating unique air, oxygen vent, blender, bubble humidifier and lower resistance breathing circuit will be used in children with respiratory distress, secondary to pneumonia in admitted in PICU for 6 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
36.00 Month(s) |
| Gender |
Both |
| Details |
All children with lower respiratory tract infection
admitted to Paediatric Intensive Care unit needing
bubble CPAP as respiratory support will be
included for the study. |
|
| ExclusionCriteria |
| Details |
Children admitted to Paediatric Intensive Care unit. needing CPAP as respiratory support with
diagnosis other than lower respiratory tract infection will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality/ Death |
During PICU stay on CPAP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of CPAP use |
during PICU stay |
| Intubation |
During PICU stay |
| Nasal injury - skin erosion , ulceration, bleeding, septal, injury, or scaring |
During PICU stay |
Airleak syndromes
pneumothorax ,pneumomediastinum, & pneumopericardium |
During PICU stay |
| Duration of hospital stay |
At discharge |
| Nasopharyngeal swab culture |
During PICU stay |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Pneumonia is a leading infectious cause of death globally among children younger than five years. Accounting for one third of all under five deaths from infection. More than 99% of pneumonia deaths are in low and middle income countries and closely linked to poverty. It is one of the most important causes of under five deaths in India . More than 1.1 million, under five years of age children die from pneumonia every year accounting for almost 17% under five deaths worldwide . In India during the year 2013 about 31.7 million cases of acute respiratory infections were reported during 2013 about 3278 people died of ARI and 2597 died of pneumonia Pneumonia was responsible for about 18% of all under five year deaths in India interventions that affect mortality due to pneumonia are thus of greater importance. In any effort to improve childhood survival. The annual global incidence of pneumonia is 9 to 0000 new cases per year out of which 282000 occurring in South Asia , though, there is evidence of decreased mortality and decreased need for invasive ventilation after use of CPAP in managing units with respiratory distress, secondary to RDS , MAS and apnoea of prematurity in NICU. There is only limited evidence for use of CPAP in infants and children with respiratory conditions like pneumonia, ARDS, pulmonary edema and status asthmaticus with very few observational and randomised control studies, indicating that CPAP exhibits promising potential in enhancing ventilation and oxygenation among infants, with pneumonia with respiratory distress and use of CPAP, may mitigate the need for endotracheal, intubation and potentially need to shorter duration of PICU stays for the young patients . Among different CPAP devices, bubble CPAP demonstrate the specific advantage of cost effectiveness, ease of assembling and its operability with any available oxygen source gives it an upper hand in low and middle income countries. Nevertheless, there is minimal evidence of CPAP efficacy in pneumonia. This study aims to investigate low-cost bubble CPAP, safety and effectiveness in paediatric respiratory distress. As a result of pneumonia, filling a critical knowledge gap in paediatric respiratory care to minimise mortality and morbidity . |