| CTRI Number |
CTRI/2024/06/068571 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Intravenous Hydrocortisone versus Intravenous Dexamethasone in Children Hospitalized with Acute Severe Asthma aged 2 to 14 years |
|
Scientific Title of Study
|
Intravenous Hydrocortisone
versus Intravenous Dexamethasone in Children Hospitalized with Acute Severe Asthma: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 Kapil Bhalla |
| Designation |
Professor |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak Haryana |
| Address |
Department of Paediatrics
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS)
Rohtak HARYANA 124001 India
Rohtak
HARYANA
124001
India |
| Phone |
9813743565 |
| Fax |
|
| Email |
kapil_bhalla@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepika |
| Designation |
Post Graduate |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak |
| Address |
Department of Paediatrics
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS)
Rohtak HARYANA 124001 India
Rohtak
HARYANA
124001
India |
| Phone |
7056151460 |
| Fax |
|
| Email |
drdeepika714@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika |
| Designation |
Post Graduate |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak |
| Address |
Department of Paediatrics
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS)
Rohtak HARYANA 124001 India
Rohtak
HARYANA
124001
India |
| Phone |
7056151460 |
| Fax |
|
| Email |
drdeepika714@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak,
Haryana - 124001 |
|
|
Primary Sponsor
|
| Name |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak, Haryana - 124001
|
| Type of Sponsor |
Government medical college |
|
|
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 Deepika |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak |
Department of Paediatrics
Emergency Room no.11
Rohtak
HARYANA |
7056151460
drdeepika714@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J455||Severe persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone |
Intravenous Dexamethasone 0.6 mg/kg single dose, max. dose of 16 mg/day and to be repeated after 24 hours if required and if a child can take it orally, to be given oral 0.6mg/kg single dose on Day 2 of admission |
| Comparator Agent |
Hydrocortisone |
Intravenous Hydrocortisone (8 mg/kg) max dose of 100 mg followed by 4 mg/kg q8h on Day 1 and if child is accepting orally to be shifted on Oral Prednisolone 1 mg/kg/day for 4 days. And if
the child is not accepting orally we will give Intravenous hydrocortisone 4 mg/kg/day divided 12h on Day 2 and 4 mg/kg single dose on Day 3. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with acute severe asthma consistent with severity as per Global Initiative for Asthma Guidelines and Pediatric Asthma Severity Score |
|
| ExclusionCriteria |
| Details |
I. Patients with cardiovascular, neurological, psychiatric, neoplastic, or renal disease.
II. Patients with respiratory conditions like pneumonia, pneumothorax, or
pneumomediastinum will be excluded.
III. Those children whose parents refused to give consent to participate in the study.
IV. Children who have received any systemic steroid preparations in the last 15 days before
hospital arrival. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of stay in the emergency department
Length of stay in Hospital
Need for PICU Transfer |
6 hours to 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Auscultatory findings
Frequency of betaagonist
Need for respiratory support
Any other drug requires like MGSO4
Glucose level |
6 hours, 12 hours, 24 hours, 48 hours |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/06/2024 |
| Date of Study Completion (India) |
01/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Corticosteroids play an important role in the management of Acute Severe Asthma and are the mainstay treatment of asthma. Published literature addressing the dose and type of steroids is very conflicting. Although the role of Intravenous corticosteroids in acute asthma is well established, this study aims to compare two Intravenous steroid preparations i.e. Hydrocortisone and Dexamethasone in the management of patients presenting with Acute Severe Asthma.
Patients will be divided into two groups: Group I will receive Intravenous Dexamethasone 0.6 mg/kg single dose, max. dose of 16 mg/day and to be repeated after 24 hours if required and if a child can take it orally, to be given oral 0.6mg/kg single dose on Day 2 of admission and Group II will receive Intravenous Hydrocortisone (8 mg/kg) max dose of 100 mg followed by 4 mg/kg q8h on Day 1 and if child is accepting orally to be shifted on Oral Prednisolone 1 mg/kg/day for 4 days. And if the child is not accepting orally we will give Intravenous hydrocortisone 4 mg/kg/day divided 12h on Day 2 and 4 mg/kg single dose on Day 3. |