FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Status 
Not Applicable 
 
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 .
 
Close