| CTRI Number |
CTRI/2024/12/078093 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To study the effectiveness of nebulised hypertonic saline 3 percent versus 7 percent in acute bronchiolitis in young children. |
|
Scientific Title of Study
|
Effectiveness of nebulised hypertonic saline 3 percente versus 7 percent in acute bronchiolitis in young children: A randomised controlled study. |
| 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.Shreedhar Giri |
| Designation |
Dnb Trainee |
| Affiliation |
Sri Balaji Action Medical Institute. |
| Address |
Pediatric ICU ,Second floor , Room no 2158,Sri Balaji Action Medical Institute, Paschim Vihar , NEW DELHI 10063
West
DELHI
110063
India |
| Phone |
8446281134 |
| Fax |
|
| Email |
shreedhargiri91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Virender Kumar |
| Designation |
Senior consultant |
| Affiliation |
Sri Balaji Action Medical Institute |
| Address |
Room no. 1106, First floor,Department of Pediatrics and Neonatology.
Sri Balaji Action Medical Intitute, Paschim Vihar , NEW DELHI.
West
DELHI
110063
India |
| Phone |
9810180889 |
| Fax |
|
| Email |
kumar_virender@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shreedhar Giri |
| Designation |
Dnb trainee |
| Affiliation |
Sri Balaji Action Medical Institute |
| Address |
Room no. 2159, Second floor Pediatric ICU,Sri Balaji Action Medical Institute, A4 Paschim Vihar , NEW DELHI.
West
DELHI
110063
India |
| Phone |
8446281134 |
| Fax |
|
| Email |
shreedhargiri91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Balaji Action Medical Institute,A4 Paschim Vihar, New Delhi, India 110063. |
|
|
Primary Sponsor
|
| Name |
Dr Shreedhar Giri |
| Address |
Room no. 2159, Second floor Pediatric ICU,Sri Balaji Action Medical Institute, A4 Paschim Vihar , NEW DELHI 110063. |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR VIRENDER KUMAR |
SRI BALAJI ACTION MEDICAL INSTITUTE, PASCHIM VIHAR, NEW DELHI |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shreedhar Giri |
Sri Balaji Action Medical Institute |
Room no. 2158,Second floor,Pediatric ICU, department of Pediatrics and Neonatology.
West
DELHI |
8446281134
shreedhargiri91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Balaji Action Medical Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
3ml of 3 percent hypertonic saline with the combination of nebulised adrenaline[0.1ml/kg/dose in 1 in 10000 solution] |
3 percent hypertonic saline with the combination of nebulised adrenaline nebulisation every 4 hourly via conventional jet nebulizer (Romsans Aero Mist Ref Sh 2074) With Mask connected to oxygen flow. This is to be continued till patient will be discharged. |
| Comparator Agent |
3ml of 7 percent hypertonic saline with the combination of nebulised adrenaline[0.1ml/kg/dose in 1 in 10000 solution] |
7 percent hypertonic saline with the combination of nebulised adrenaline nebulisation every 4 hourly via conventional jet nebulizer (Romsans Aero Mist Ref Sh 2074) With Mask connected to oxygen flow. This is to be continued till patient will be discharged. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
Children between 2-24 months of age with acute bronchiolitis (defined as an acute viral infection of the lowe respiratory tract affecting young children between 2 to 24 months and is charecterized by respiratory distress, wheezing and or crackles without any other explanation such as pneumonia or atopy). |
|
| ExclusionCriteria |
| Details |
Children presenting with
1 Use of bronchiodilators or taken any treatment previously or just before presentation to the hospital.
2 History of congenital heart disease.
3 Immunodeficiency disorders.
4 Patients on mechanical ventilation. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Length of stay in hospital. |
It will be calculated at the time of discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need And Duration Of Oxygen Support. |
At the time of discharge. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/12/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Acute bronchiolitis is an important cause of morbidity in young children. It is the most common cause of hospitalization due to lower respiratory tract infection.Bronchiolitis is an infection typically caused by viruses. With an improvement in diagnostic ability to identify viruses in respiratory secretions, multiple viral agents like Respiratory syncytial virus (RSV), Rhinovirus, Parainfluenza virus, Adenovirus have been identified as causative agents in acute bronchiolitis.RSV is the most common cause of acute bronchiolitis counting for 50 to 80 percent cases. Aerosolised hypertonic saline has been proposed as a therapeutic modality for acute bronchiolitis. Hypertonic saline may reverse some pathophysiological abnormalities in acute bronchiolitis by decreasing epithelial edema, improving elasticity and viscosity of mucus and thus improving airway clearance. At present there is still dilemma over effectivness of different concentrations of hypertonic saline. In the present scenario respiratory illness profile is being clearly outlined as viral or bacterial, it necessitates the need for more precise guidlines for further management.Therefore the current study is undertaken to know the effect of nebulised 3 percent hypertonic saline in young children with acute bronchiolitis compared to those receiving nebulised 7 percent saline. |