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CTRI Number  CTRI/2025/02/080142 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 08/02/2025
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study
Modification(s)  		 Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Nebulization with Adrenaline and Hypertonic saline vs Hypertonic saline alone in Acute Bronchiolitis. 
Scientific Title of Study   Study to evaluate the Efficacy and Safety of nebulization with Adrenaline and 3% Hypertonic saline vs nebulization with 3% Hypertonic saline alone in Acute Bronchiolitis: A 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  Dr Trigunateet Gupta 
Designation  MD Pediatrics student  
Affiliation  Narayan Medical College and Hospital 
Address  Department of Pediatrics, Narayan Medical College and Hospital,Jamuhar,Sasaram,Rohtas

Rohtas
BIHAR
821305
India 
Phone  9236025726  
Fax    
Email  trigunateetgupta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mani Kant Kumar 
Designation  Guide, Professor and Head,Department of Pediatrics  
Affiliation  Narayan Medical College and Hospital 
Address  Room No-12,Department of Pediatrics, Narayan Medical College and Hospital,Jamuhar,Sasaram,Rohtas

Rohtas
BIHAR
821305
India 
Phone  9162095353  
Fax    
Email  manikant7@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Amit Shekharay 
Designation  Assistant Professor 
Affiliation  Narayan Medical College and Hospital 
Address  Room No-13,Department of Pediatrics,Narayan Medical College and Hospital,Jamuhar,Sasaram,Rohtas.

Rohtas
BIHAR
821305
India 
Phone  9264105388  
Fax    
Email  medico_amit4@rediffmail.com  
 
Source of Monetary or Material Support  
Department of Pediatrics,Narayan Medical College and Hospital,Sasaram ,Rohtas,821305 
Dr Trigunateet Gupta,postgraduate student,department of pediatrics,narayan medical college and hospital,sasaram,rohtas,821305. 
 
Primary Sponsor  
Name  Narayan Medical College and HospitalJamuharSasaram 
Address  Room No-12,Department of Pediatrics,Narayan Medical College and Hospital,Jamuhar,Sasaram,Rohtas 
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 Trigunateet Gupta  Narayan Medical College and Hospital  Room no.12,Department of pediatrics.
Rohtas
BIHAR 		 9236025726

trigunateetgupta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J219||Acute bronchiolitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  3% HYPERTONIC SALINE  Nebulized inhalation of hypertonic 3% saline alone, administered at every 4 hours for 3 days and then modified as per patient’s need. 
Intervention  ADRENALINE AND 3% HYPERTONIC SALINE  Nebulized inhalation of epinephrine and hypertonic 3% saline, administered at every 4 hours for 3 days and then modified as per patient’s need 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  24.00 Month(s)
Gender  Both 
Details  Admitted patient with a chronological age of 2 months to 24 months, a clinical diagnosis of Acute bronchiolitis and their initial Wang respiratory score will be 3 or higher will be enrolled in this study 
 
ExclusionCriteria 
Details  Attendants not giving consent.
Children with prior illness with wheezing.
Children with prior use of bronchodilators.
Premature infants (<34wks of gestation).
Children with congenital heart disease.
Children with chronic lung disease.
Severe bronchiolitis (either wang CSS >9 or baseline oxygen saturation <85%)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1-To evaluate the efficacy of nebulization with adrenaline and 3% hypertonic saline vs nebulization with 3% hypertonic saline alone.
2-To evaluate the safety of nebulization with adrenaline and 3% hypertonic saline vs nebulization with 3% hypertonic saline alone.
 		 Evaluation Every 24 Hour 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the changes in clinical scoring after nebulization with adrenaline & 3% hypertonic saline vs nebulization with 3% hypertonic saline alone  Evaluation Every 24 Hour. 
To evaluate the changes in average length of hospital stay after nebulization with adrenaline & 3% hypertonic saline vs nebulization with 3% hypertonic saline alone  Evaluation every 24 hour 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   17/02/2025 
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="2"
Months="0"
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   Acute Bronchiolitis is a lower respiratory tract viral infection that primarily affects the small airways(bronchioles).RSV is the most common cause.Bronchiolitis remains a significant cause of respiratory disease during the first 2 years of life.Diagnosis of bronchiolitis is largely clinical.Treatment is mostly supportive such as oxygen supplementation and hydration.Antibiotics have proven to be ineffective.Treatment with nebulized adrenaline with 3% hypertonic saline have found to decrease severity of symptoms in infants with acute viral bronchiolitis as well as shorten the duration of hospitalization.It is simple,seemingly efficient and cost effective with excellent safety profile.Hence,more research is warranted for further confirmation and expansion of data to clarify this potential treatment modality. 
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