| CTRI Number |
CTRI/2025/02/080366 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
26/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Heated Humidified High-Flow Nasal Cannula (HHHFNC) Driven Nebulization |
|
Scientific Title of Study
|
A Randomized Controlled Trial on the Efficacy of Heated Humidified High-Flow Nasal Cannula (HHHFNC) Driven Nebulization vs. Conventional Nebulization in children with Bronchiolitis |
| 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 K Manikandan Arunasalam |
| Designation |
post graduate |
| Affiliation |
Department of Paediatrics, Chettinad Hospital and Research Institute |
| Address |
Department of Paediatrics, Chettinad Hospital and Research Institute, Rajiv Gandhi salai, OMR, Kelambakkam, Chennai
Chennai
TAMIL NADU
603103
India |
| Phone |
9894883024 |
| Fax |
|
| Email |
arunasalam17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alexander |
| Designation |
post graduate |
| Affiliation |
Department of Paediatrics, Chettinad Hospital and Research Institute |
| Address |
Department of Paediatrics, Chettinad Hospital and Research Institute, Rajiv Gandhi salai, OMR, Kelambakkam, Chennai
Chennai
TAMIL NADU
603103
India |
| Phone |
9551607900 |
| Fax |
|
| Email |
paedsalex@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alexander |
| Designation |
post graduate |
| Affiliation |
Department of Paediatrics, Chettinad Hospital and Research Institute |
| Address |
Department of Paediatrics, Chettinad Hospital and Research Institute, Rajiv Gandhi salai, OMR, Kelambakkam, Chennai
Chennai
TAMIL NADU
603103
India |
| Phone |
9551607900 |
| Fax |
|
| Email |
paedsalex@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics, Chettinad Hospital and Research Institute, Rajiv Gandhi salai, OMR, Kelambakkam, Chennai, Pincode - 603103 |
|
|
Primary Sponsor
|
| Name |
Manikandan Arunasalam Kasi |
| Address |
Chettinad hospital and research institute Rajiv Gandhi salad OMR Kelambakkam Chennai |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Manikandan Arunasalam Kasi |
Chettinad hospital and Research Institute |
Chettinad hospital and Research Institute Rajiv Gandhi salai OMR Kelambakkam Chennai
Chennai
TAMIL NADU |
9894883024
arunasalam17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chettinad Academy of Research and Education Institutional Human Ethics Committee for Student Research (CARE IHEC-I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J211||Acute bronchiolitis due to human metapneumovirus, (2) ICD-10 Condition: J218||Acute bronchiolitis due to other specified organisms, (3) ICD-10 Condition: J210||Acute bronchiolitis due to respiratory syncytial virus, (4) ICD-10 Condition: J219||Acute bronchiolitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional nebulization |
Conventional nebulization using [standard nebulizer device] with recommended aerosol therapy.
Duration of study : 12 to 18 months
No specified frequency, continued throughout the course of the individual treatment. |
| Intervention |
Heated Humidified High Flow Nasal Cannula (HHHFNC) driven nebulization |
HFNC-driven nebulization using jet nebuliser (connected to the HFNC through a T channel) with recommended aerosol therapy.
Duration of study : 12 to 18 months
No specified frequency, continued throughout the course of the individual treatment.
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
Infants and young children aged 0-2 years with bronchiolitis diagnosed clinically by physician supported by X-ray and laboratory investigations will be included.
|
|
| ExclusionCriteria |
| Details |
Any patients requiring immediate respiratory support (non-invasive or invasive mechanical ventilation), altered mental status, or apnoea at presentation), those already admitted to the ICU due to respiratory failure, those with underlying chronic lung disease or cardiovascular disorders, those with obstructions of the upper respiratory tract, and those with cranial malformations will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in respiratory distress scores from baseline. (Downes score)
|
Duration of study : 12 to 18 months
No specified frequency, continued throughout the course of the individual treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Need for Escalation of respiratory support.
|
12 to 18 months |
Duration of hospital stay.
|
12 to 18 months |
| Adverse events related to the nebulization technique. |
12 to 18 months |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/02/2026 |
| Date of Study Completion (India) |
30/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Bronchiolitis is a common lower respiratory tract infection in infants and young children. It is leading cause of hospitalization in under 5 age group. It is commonly caused by viral infections such as Respiratory Syncytial Virus (RSV) and uncommonly by Human metapneumovirus, Rhinoviruses etc. It is characterized by bronchoconstriction, airway wall inflammation, increased mucus production and air flow obstruction. Nebulized bronchodilators and hypertonic saline are commonly used in the management of bronchiolitis. Heated humidified High-Flow Nasal Cannula (HHHFNC, hereafter referred to as HFNC) is a widely used non-invasive ventilatory support in children with bronchiolitis in the intensive care setting and has gained popularity as a respiratory support modality. Scarce data is available on HFNC use in the general pediatric ward and its effectiveness in delivering medications to the lower airways is under investigation for obstructive airway disease. This study aims to compare the efficacy of HFNC-driven nebulization with conventional nebulization in young children with bronchiolitis. |