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CTRI Number  CTRI/2024/08/073107 [Registered on: 29/08/2024] Trial Registered Prospectively
Last Modified On: 24/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of nebulisation through vibration mesh technique vs jet nebulisation in children with acute asthma 
Scientific Title of Study   A randomized controlled open label trial (RCT) of vibration mesh technology (Aeroneb) vs conventional jet nebulization in children with moderate to severe Acute Asthma. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nikhita V N 
Designation  Maj Dr 
Affiliation  INHS ASVINI 
Address  Department of peadiatrics, Room no 4, 4th floor, INHS Asvini,near RC Church, Navy nagar, colaba

Mumbai
MAHARASHTRA
400005
India 
Phone  8884341084  
Fax    
Email  nikitavn1992@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bal Mukund 
Designation  Surgeon captain 
Affiliation  INHS Asvini 
Address  Associate professor Department of paediatrics Institute of naval medicine, INHS Asvini Near RC Church, navy nagar colaba mumbai

Mumbai
MAHARASHTRA
40005
India 
Phone  8727073888  
Fax    
Email  bmdoc2002@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Bal Mukund 
Designation  Surgeon captain 
Affiliation  INHS Asvini 
Address  Associate professor Department of paediatrics Institute of naval medicine, INHS Asvini Near RC Church, navy nagar colaba mumbai

Mumbai
MAHARASHTRA
40005
India 
Phone  8727073888  
Fax    
Email  bmdoc2002@rediffmail.com  
 
Source of Monetary or Material Support  
INHS Asvini, Mumbai 400005 
 
Primary Sponsor  
Name  Nikhita V N 
Address  Department of peadiatrics, 4th floor, room no.4, INHS Asvini near R.C church,colaba 400005 
Type of Sponsor  Other [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 
Surgeon captain Bal Mukund  INHS Asvini  Department of peadiatrics, room no.4, 4th floor, Institute of naval medicine INHS Asvini near RC Church Navy nagar colaba
Mumbai
MAHARASHTRA 
8727073888

bmdoc2002@rediff.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of naval medicine INHS Asvini ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J459||Other and unspecified asthma, (2) ICD-10 Condition: J459||Other and unspecified asthma, (3) ICD-10 Condition: J96-J99||Other diseases of the respiratory system, (4) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  jet nebulisation-The drug/medicines used will be same in both arms , the only difference will be method of nebulisation.  Following drugs will be used in both arms equally-For nebulisation 1.Salbutamol in the dosage of 2.5mg in 10 kg, 5mg in 10 kg, to be diluted with 3-5ml NS and used as nebulisation 2.Budesonide 500mcg respules diluted in 3ml NS in nebulisation 3.Ipra-atropium bromide in moderate to severe cases 800mcg respules diluted in 3ml NS.in nebulisation Moderate to severe cases will also require iv/oral steroids, prednisolone 2mg/kg/day oral or hydrocortisone 10mg/kg stat iv followed by 5mg/kg 6th hourly or methylprednisolone 1-2mg/kg/day iv 6th hourly in divided doses according to IJP article. In non- responder, intravenous magnesium sulphate will also be used in both the arms as per recommendation of GINA 2024.( refer Grover s et al.Acute bronchial asthma .Indian J Pediatr 2011 and GINA publication 2024 
Comparator Agent  Vibration mesh technology based nebulisation ( aerogen solo/aerogen Ultra, make- Aerogen Ireland)  Following drugs will be used in both arms equally-For nebulisation 1.Salbutamol in the dosage of 2.5mg in 10 kg, 5mg in 10 kg, to be diluted with 3-5ml NS and used as nebulisation 2.Budesonide 500mcg respules diluted in 3ml NS in nebulisation 3.Ipra-atropium bromide in moderate to severe cases 800mcg respules diluted in 3ml NS.in nebulisation Moderate to severe cases will also require iv/oral steroids, prednisolone 2mg/kg/day oral or hydrocortisone 10mg/kg stat iv followed by 5mg/kg 6th hourly or methylprednisolone 1-2mg/kg/day iv 6th hourly in divided doses according to IJP article. In non- responder, intravenous magnesium sulphate will also be used in both the arms as per recommendation of GINA 2024.( refer Grover s et al.Acute bronchial asthma .Indian J Pediatr 2011 and GINA publication 2024  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Any child aged 2- 18 years with moderate to severe acute asthma, i.e. CASS score ≥ 4 
 
ExclusionCriteria 
Details  1 Any child with acute asthma who already received nebulization in present episode of exacerbation.
2 cardiovascular disease
3 cystic fibrosis
4 chronic lung disease
5 airway anomalies
•immunodeficiency syndromes
•coexisting medical conditions such as pneumonia, or if they were in impending respiratory failure.
•Patients who already received bronchodilator treatment within 24 hrs of the emergency department presentation.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
In patients with acute moderate to severe asthma we will assess improvement in CAS Score less than or equal to 2 with clinical improvement(No respiratory distress, improved oral intake, able to comprehend)  For first 6 hrs we will assess improvement in CAS score less than or equal to 2 with clinical improvement, followed by assessment every 2-4hrs.  
 
Secondary Outcome  
Outcome  TimePoints 
• To study the duration of admission rate and hospital stay in both the groups
• To study the difference in dosage requirement of SABA after initial first hour nebulization in both groups 
20 months 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   16/09/2024 
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)  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  

Asthma is a common and potentially serious chronic disease that imposes a substantial burden on patients, their families, and community. Asthma is a common disease amongst children in India with prevalence estimated at 5-10%. A worldwide increase in the prevalence of asthma is being reported with increase in wheeze at an alarming rate of 5% per year.

Globally, about 30–35% of children suffer from allergic disorders, and the prevalence of these illnesses has been rising in recent years. Atopic dermatitis, allergic rhinitis, asthma, and food allergies are some of the childhood allergic disorders, of which asthma is the most common chronic condition among children and adults.[1]


Bronchial asthma is a chronic inflammatory disorder in which several cells and cellular elements are involved. In susceptible individuals this inflammation causes recurrent episodes of wheezing, breathlessness, chest tightness and cough, particularly at night and early morning. These episodes are associated with variable and widespread airway obstruction that is often reversible either spontaneously or with treatment. The inflammation also causes increase in bronchial hyper-’ responsiveness to a variety of stimuli.

Asthma can severely limit the ability to engage in normal daily activities, including sports and outdoor activities, poor sleep, fatigue, and permanent decline in lung function.[2] It accounts for more than 10 million missed school days each year and is the third principal cause of child hospitalization.[3]

The main treatment of an acute exacerbation includes inhaled short-acting β2-agonists (SABA) and inhaled anticholinergic like ipratropium bromide and inhaled corticosteroids in moderate to severe cases. Nebulizers are commonly used in emergency departments to deliver bronchodilators to children with asthma exacerbations.

However, no clinical study comparing a vibrating mesh nebulizer with a jet nebulizer is available in this paediatric population. The vibration mesh technology-based nebulisation may be more effective as drug deposition is 6-8 times more than jet and ultrasonic nebulisation in the patients small airways.  

The aim of this of study was to compare the clinical efficacy of a jet nebulizer and aerogen using vibration mesh technology for delivering SABA in children aged 2-18 years presenting to the emergency department with moderate to severe acute asthma 
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