| CTRI Number |
CTRI/2025/09/095046 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Clinical Improvement Using Nebulised Nacetylcysteine Versus Nebulised 3 percent Hypertonic Saline For Acute Bronchiolitis |
|
Scientific Title of Study
|
Comparison of Clinical Improvement Using Nebulised Nacetylcysteine Versus Nebulised 3 percent Hypertonic Saline For Acute Bronchiolitis: A Randomised Controlled Trial |
| 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 Sujaya Mukhopadhyay |
| Designation |
Associate Professor |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Pediatrics
Ground Floor
GIMS Hospital
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8588818346 |
| Fax |
|
| Email |
sujaya.mukhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aarti |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences |
| Address |
Department of Pediatrics
Ground Floor
GIMS Hospital
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8307668434 |
| Fax |
|
| Email |
aartimalik789@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aarti |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences |
| Address |
Department of Pediatrics
Ground Floor
GIMS Hospital
UTTAR PRADESH
201310
India |
| Phone |
8307668434 |
| Fax |
|
| Email |
aartimalik789@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of Institute of Medical Sciences (GIMS)
Kasna, Greater Noida
Gautam Buddha Nagar
Pin-201310 |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences Greater Noida |
| Address |
Kasna, Greater Noida Gautam Buddha Nagar Pin-201310 |
| Type of Sponsor |
Government 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 Aarti |
Government Institute of Medical Sciences (GIMS) |
Room 19, ground floor Department of Pediatrics
Gautam Buddha Nagar
UTTAR PRADESH |
8307668434
aartimalik789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GIMS Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J219||Acute bronchiolitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nebulisation of 3%
Hypertonicsaline |
2 ML 8 hourly
along with standard supportive
care |
| Intervention |
Nebulised N-Acetylcysteine |
2 ML 8 hourly along with
standard supportive care |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
parents have provided consent for their participation in the study with diagnosis of Bronchiolitis hospitalized in NICU or PICU or ward and a clinical severity score of more than 4 on presentation |
|
| ExclusionCriteria |
| Details |
Patients affecting with:
1. congenital cardiac diseases
2.anatomical pulmonary defects
3.bronchopulmonary dysplasia
4.chronic lung disease
5.neuromuscular impairment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the change in pre and post clinical severity scores in patients with bronchiolitis receiving nebulised N-Acetylcysteine versus Nebulised 3%Hypertonic Saline |
From Baseline to end of study at day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the duration of hospitalization in both the groups.
2.To compare the duration of ventilation or oxygen support if required among both the groups
|
From Baseline to end of study at day 5 |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/10/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Aim of study-
Comparison of clinical improvement using nebulised N-Acetylcysteine
versus Nebulised 3%Hypertonic Saline for Acute Bronchiolitis.
Objectives-
Primary objective-
To compare the change in pre and post clinical severity scores in
patients with bronchiolitis receiving nebulised
N-Acetylcysteine versus Nebulised 3%Hypertonic Saline
Secondary objectives-
1. To compare
the duration of hospitalization in both the groups.
2. To compare
the duration of ventilation or oxygen support
if required among both the groups
Operational definitions-
ยท
Bronchiolitis -Patient <2 years of age with prodromal history
consistent with upper respiratory
tract infection followed by wheezing and/or crackles on auscultation1 |