| 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
|
|
|
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
|
|
|
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. |