| CTRI Number |
CTRI/2020/06/026071 [Registered on: 23/06/2020] Trial Registered Prospectively |
| Last Modified On: |
20/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Comparing standard therapy and use of high pressure oxygen in children with Bronchiolitis . |
|
Scientific Title of Study
|
Continuous positive airway pressure (CPAP) and standard therapy in children with bronchiolitis - A comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay Kumar Arya |
| Designation |
Prof and HOD |
| Affiliation |
Hemwati Nandan Bahuguna Uttarakhand Medical Education University, Dehradun |
| Address |
Department of pediatrics, GMC campus, Rampur road, Haldwani
Nainital
UTTARANCHAL
263139
India
Nainital
UTTARANCHAL
263139
India |
| Phone |
9837251413 |
| Fax |
|
| Email |
drajayarya2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Arya |
| Designation |
Prof and HOD |
| Affiliation |
Hemwati Nandan Bahuguna Uttarakhand Medical Education University, Dehradun |
| Address |
Department of pediatrics, GMC campus, Rampur road, Haldwani
Nainital
UTTARANCHAL
263139
India
Nainital
UTTARANCHAL
263139
India |
| Phone |
9837251413 |
| Fax |
|
| Email |
drajayarya2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar Arya |
| Designation |
Prof and HOD |
| Affiliation |
Hemwati Nandan Bahuguna Uttarakhand Medical Education University, Dehradun |
| Address |
Department of pediatrics, GMC campus, Rampur road, Haldwani
Nainital
UTTARANCHAL
263139
India
Nainital
UTTARANCHAL
263139
India |
| Phone |
9837251413 |
| Fax |
|
| Email |
drajayarya2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr S Muralikrishna
Room F 14 sushila tiwari medical college nainital uttarakhand |
|
|
Primary Sponsor
|
| Name |
Dr S Muralikrishna |
| Address |
PG JR 1, Department of pediatrics, GMC Haldwani, Rampur, Nainital |
| 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 |
| Dr S Muralikrishna |
Susheela Tiwari Medical Hospital |
Department of
pediatrics, Haldwani,
Nainital
Nainital
UTTARANCHAL
Nainital
UTTARANCHAL |
8281619870
drsmkriz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government medical college Haldwani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J219||Acute bronchiolitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuous Positive Airway Pressure (CPAP) |
will give continuous positive airway pressure in children with bronchiolitis and will compare its effect with the standard therapy. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
Presence of respiratory distress
Presence of wheeze on auscultation
Childs parents giving consent |
|
| ExclusionCriteria |
| Details |
Infant in respiratory failure and in imminent need of ventilatory support.
History of lung disease.
Children with cleft palate, tracheo-esophageal fistula, cardiac disease, diaphragmatic hernia. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare silverman score between the two groups |
1st hour, 6th hour, 12th hour, 24th hour, 48th hour, 72nd hour, 96th hour and 120th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare spo2, respiratory rate, heart rate, temperature, chest movements, intercostal retraction, xiphoid retraction, nasal flare and expiratory grunt |
1st hour, 6th hour, 12th hour, 24th hour, 48th hour, 72nd hour, 96th hour and 120th hour |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/07/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare silverman score between the patients who are using CPAP and the patients using standard therapy. Expecting benefits of better recovery in almost equal cost of standard therapy and reducing hospital stay. |