| 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
|
|
|
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
|
|
|
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 |