CTRI

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CTRI Number

CTRI/2025/06/089869 [Registered on: 30/06/2025] Trial Registered Prospectively

Last Modified On:

28/06/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

Comparison of effectiveness between 7%,3%,0.9% saline nebulization as treatment option for moderate to severe bronchiolitis in children aged 1 month to 2 year who are admitted in medical college Aurangabad.

Scientific Title of Study

Comparison of Efficacy between 7% , 3% and 0.9% Saline Solution in the Management of Moderate to Severe Bronchiolitis in Children aged 1 to 24 months admitted in a Tertiary Care Hospital - A Multiarm Single Blinded Randomized 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	MD ABDUL AZAM MD NAEEM INAMDAR
Designation	JUNIOR RESIDENT
Affiliation	GOVERNMENT MEDICAL COLLEGE AURANGABAD
Address	WARD 24, DEPARTMENT OF PAEDIATRICS, CASUALTY BUILDING, GOVERNMENT MEDICAL COLLEGE AURANGABAD, AURANGABAD NEAR MASJID,INAYAT NAGAR,OLD PEDGAON ROAD, PARBHANI Aurangabad MAHARASHTRA 431001 India
Phone	8788300378
Fax
Email	abdulazam1206@gmail.com

Details of Contact Person
Scientific Query

Name	DR PRABHA KHAIRE(MORE)
Designation	PROFESSOR AND HEAD, DEPARTMENT OF PAEDIATRICS
Affiliation	GOVERNMENT MEDICAL COLLEGE AURANGABAD
Address	WARD 24, DEPARTMENT OF PAEDIATRICS, CASUALTY BUILDING, GOVERNMENT MEDICAL COLLEGE AURANGABAD, AURANGABAD NADANVAN COLONY, AURANGABAD Aurangabad MAHARASHTRA 431001 India
Phone	9850947118
Fax
Email	pmorekhaire@rediffmail.com

Details of Contact Person
Public Query

Name	MD ABDUL AZAM MD NAEEM INAMDAR
Designation	JUNIOR RESIDENT
Affiliation	GOVERNMENT MEDICAL COLLEGE AURANGABAD
Address	WARD 24, DEPARTMENT OF PAEDIATRICS, CASUALTY BUILDING, GOVERNMENT MEDICAL COLLEGE AURANGABAD, AURANGABAD NEAR MASJID,INAYAT NAGAR,OLD PEDGAON ROAD, PARBHANI Aurangabad MAHARASHTRA 431001 India
Phone	8788300378
Fax
Email	abdulazam1206@gmail.com

Source of Monetary or Material Support

MD ABDUL AZAM MD NAEEM INAMDAR PEDIATRICS JUNIOR RESIDENT DEPARTMENT OF PAEDIATRICS GOVERNMENT MEDICAL COLLEGE, AURANGABAD AURANGABAD 431001 MAHARASHTRA INDIA

Primary Sponsor

Name	MD ABDUL AZAM MD NAEEM INAMDAR
Address	WARD 24, DEPARTMENT OF PAEDIATRICS, CASUALTY BUILDING, GOVERNMENT MEDICAL COLLEGE AURANGABAD 431001
Type of Sponsor	Other [Principal investigator SELF]

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
MD ABDUL AZAM MD NAEEM INAMDAR	PEDIATRICS WARD 24,25, PEDIATRICS INTENSIVE CARE UNIT GOVERNMENT MEDICAL COLLEGE AURANGABAD	WARD 24, DEPARTMENT OF PAEDIATRICS,CASUALTY BUILDING, GOVERNMENT MEDICAL COLLEGE AURANGABAD 431001 Aurangabad MAHARASHTRA	8788300378 abdulazam1206@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE GOVT. MEDICAL COLLEGE AURANGABAD	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: J210\|\|Acute bronchiolitis due to respiratory syncytial virus,

Intervention / Comparator Agent

Type	Name	Details
Intervention	0.9 percent saline	nebulization of 2.5 mL 0.9 % hypotonic saline 6 hourly till 5 days of admission
Comparator Agent	3 percent Saline	nebulization of 2.5 mL 3 % hypertonic saline 6 hourly till 5 days of admission
Intervention	7 percent saline	Nebulization of 2.5 mL 7 % hypertonic saline 6 hourly till 5 days of admission

Inclusion Criteria

Age From	1.00 Month(s)
Age To	24.00 Month(s)
Gender	Both
Details	All Children between 1 to 24 months of age with moderate to severe bronchiolitis admitted in the Paediatric Ward and PICU.

ExclusionCriteria

Details

1. Children with Cardiac Diseases.
2. Children with Major Congenital Anomaly.
3. Children already treated outside the hospital.
4. Children whose Parents will not give consent.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Pre-numbered or coded identical Containers

Blinding/Masking

Investigator Blinded

Primary Outcome

Outcome	TimePoints
Clinical improvement Reduction in hospital stay	5 days of nebulization

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="96"
Sample Size from India="96"
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)

15/07/2025

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)

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

Random allocation for the intervention of the enrolled subjects will be done by

closed, concealed allocation by the person not involved in the study, into three groups

(Group A and Group B and group C)

Group A : receiving 7 % hypertonic saline nebulization.

Group B : receiving 3 % hypertonic saline nebulization.

Group C : receiving 0.9 % normal saline nebulization.

Single blinded study , only the investigator will be blinded.

Clinical history, patient informed consent, physical examination, and study

parameters as per case record format will be recorded for all enrolled subjects.

Group A (n=32) will receive nebulization of 2.5 mL 7 % hypertonic saline(Cipla

Hyperneb 7% Respules)

Group B (n=32) will receive nebulization of 2.5 mL 3 % hypertonic saline(Cipla

Hyperneb 3% Respules)

Group C (n=32) will receive nebulization of 2.5 mL 0.9 % hypotonic saline.

Upon admission Clinical Respiratory Severity Score will be calculated and the clinical

severity will be assessed individually. The nebulization procedure will be performed

upon admission and repeated every 6 hours until discharge.

Subjects will be monitored for vital parameters (Heart Rate, SpO2, Respiratory Rate)

and the data will be recorded in preset format as given in case report form.

Physical examination of the subjects will be done every 12 hourly before the next dose

of nebulization to calculate the Clinical Respiratory Severity Score, and the same will be

charted and followed up.

Clinical outcome will be correlated with improvement in Respiratory severity score.

The subjects will be discontinued from nebulization, examination and assessment if

a. CSS <4, SaO2>92% in room air for 4 hours and no feeding difficulty.

b. Upon 5 days of nebulization completion.

Length of stay will be calculated from the first dose of study medication until clinical

decision to discontinue from the trail. All subjects will be monitored and assessed by using clinical respiratory severity score.

Statistical Analysis of the recorded data will be conducted using appropriate methods.

*PURPOSE OF STUDY*

To compare the efficacy of 7% , 3% and 0.9% saline nebulization in the

management of moderate to severe bronchiolitis among children aged 1 to 24

months using CRSS score.

To compare the clinical improvement ( length of stay in PICU and early

recovery) between children receiving nebulization of 7 % hypertonic saline

(HS), 3% HS and 0.9% Saline normal saline.

To compare the cost effectiveness of 7 % and 3% Hypertonic saline

Nebulization in treatment of bronchiolitis.

To study the adverse effect in children receiving 7% and 3% hypertonic

saline nebulization.