FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/12/099718 [Registered on: 23/12/2025] Trial Registered Prospectively
Last Modified On: 22/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [oxygen and nebulisation via single mask]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare two methods of giving oxygen and nebulization in children with breathing difficulty. 
Scientific Title of Study   Evaluation Of Clinical Outcomes Using A Nebuliser-Cum-Oxygen Mask In Pediatric Respiratory Distress 
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 Dinesh kumar 
Designation  Postgraduate 
Affiliation  Saveetha medical college hospital 
Address  ward number 120, 1st floor, Department of paediatrics, Saveetha medical college hospital, 162, Poonamallee High Road, Poonamallee, Chennai,

Chennai
TAMIL NADU
602105
India 
Phone  9788251116  
Fax    
Email  dino3661@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Navin 
Designation  assisstant professor 
Affiliation  Saveetha medical college hospital 
Address  ward number 120, 1st floor, Department of paediatrics, Saveetha medical college hospital, 162, Poonamallee High Road, Poonamallee, Chennai,

Chennai
TAMIL NADU
602105
India 
Phone  9487002379  
Fax    
Email  navinu.smc@saveetha.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dinesh kumar 
Designation  Postgraduate 
Affiliation  Saveetha medical college hospital 
Address  ward number 120, 1st floor, Department of paediatrics, Saveetha medical college hospital, 162, Poonamallee High Road, Poonamallee, Chennai,

Chennai
TAMIL NADU
602105
India 
Phone  9788251116  
Fax    
Email  dino3661@gmail.com  
 
Source of Monetary or Material Support  
Saveetha medical college hospital,162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam, Tamil Nadu, India 602105 
 
Primary Sponsor  
Name  Saveetha medical college hospital 
Address  162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam, Tamil Nadu 602105 
Type of Sponsor  Private medical college 
 
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 
Dr Dinesh  Saveetha medical college hospital  ward number 120, 1st floor, department of paediatrics, SAveetha medical college hospital, 162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam, Tamil Nadu 602105
Chennai
TAMIL NADU 
9788251116

dino3661@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional nebulizer mask  Conventional sequential therapy using separate oxygen delivery devices and nebulization masks as per standard institutional protocol 
Intervention  Nebulizer cum oxygen mask  Use of an integrated nebulizer–cum oxygen mask that allows simultaneous delivery of oxygen and nebulized medication without interruption to children with respiratory distress for a duration of 3 days during hospital stay 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children aged 1 month to 12 years presenting with mild to moderate respiratory distress, requiring both oxygen therapy and nebulization, whose parents or legal guardians provide written informed consent. 
 
ExclusionCriteria 
Details  Children with severe respiratory distress requiring immediate ventilatory support, congenital airway anomalies, chronic lung disease, known hypersensitivity to nebulized medications, or those already on advanced respiratory support. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to symptom relief ,
Oxygen saturation stability during therapy ,
Overall recovery time  
baselien, 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Cost-effectiveness of the integrated device,
User satisfaction ,
Incidence of adverse events related to device use 
baseline, 48 hours,at the time of discharge 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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 2/ Phase 3 
Date of First Enrollment (India)   09/01/2026 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Children presenting with respiratory distress frequently require both oxygen therapy and nebulization. In routine practice, these interventions are delivered using separate devices, which may lead to interruption of oxygen delivery, increased treatment time, and logistical challenges, particularly in emergency settings.This randomized, double-blinded, parallel-group controlled trial aims to evaluate the clinical outcomes of an integrated nebuliser-cum-oxygen mask compared to conventional sequential oxygen and nebulization therapy in pediatric patients with mild to moderate respiratory distress. A total of 150 children aged 1 month to 12 years attending the Department of Paediatrics at Saveetha Medical College and Hospital will be enrolled and randomly allocated to either the intervention group or the control group.The primary outcomes include time to symptom relief, stability of oxygen saturation during therapy, and overall recovery time. Secondary outcomes will assess cost-effectiveness, user satisfaction, and the incidence of adverse events. By combining two essential respiratory interventions into a single, low-cost, and easy-to-use device, this study seeks to improve treatment efficiency, enhance patient safety, and reduce healthcare burden, particularly in emergency and resource-limited pediatric care settings.

 
Close