| CTRI Number |
CTRI/2020/08/027064 [Registered on: 10/08/2020] Trial Registered Prospectively |
| Last Modified On: |
30/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of two doses of a medicine for treating acute asthma attack in children between age of 2 to 5 years |
|
Scientific Title of Study
|
Comparison of two doses of intravenous magnesium sulphate in improving the clinical
outcome of children 2 to 5 years of age with acute severe asthma - a Pilot Randomized Control Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JIP/IEC/2018/383 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chakicherla Sai Monica |
| Designation |
Junior resident |
| Affiliation |
Jipmer |
| Address |
Depart of pediatrics
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605001
India |
| Phone |
8978446854 |
| Fax |
|
| Email |
csm.chakicherla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVenkatesh chandrsekharan |
| Designation |
Associate Professor |
| Affiliation |
Jipmer |
| Address |
Depart of pediatrics
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605001
India |
| Phone |
9842534154 |
| Fax |
|
| Email |
cvenkatesh@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chakicherla Sai Monica |
| Designation |
Junior resident |
| Affiliation |
Jipmer |
| Address |
Depart of pediatrics
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605001
India |
| Phone |
8978446854 |
| Fax |
|
| Email |
csm.chakicherla@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Pondicherry Medical Education and Research |
| Address |
Dhanvantri Nagar,
Pondicherry-6 |
| 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 |
| Monica |
Jawaharlal Institute of Pondicherry Medical Education and Research |
167 room number
Pediatrics
Casualty
Pondicherry
PONDICHERRY |
8978446854
04132272067
csm.chakicherla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Magnesium sulphate |
50 mg per kg dose intravenous magnesium sulphate over 30 minutes once |
| Comparator Agent |
Magnesium sulphate |
25 mg per kg per dose intravenous over 30 minutes once |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children with acute severe asthma with PRAM score 8 or more and continue to be 8 or more one hour post intervention |
|
| ExclusionCriteria |
| Details |
Clinical suspicion of pneumonia
Acute kidney injury or hypotension
Congenital heart disease and structural airway anomalies that produce wheeze |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of children in whom intensive care admissions are prevented |
During period of hospitalization for study half an hour, two hours, four hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate serum magnesium levels to the amount of magnesium sulphate infused and clinical outcome |
one hour Before and one hour after injecting magnesium |
| Side effects of intravenous magnesium sulfate in above age group. |
During hospital stay. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/08/2020 |
| 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="0"
Months="7"
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)?
Response - NO
|
|
Brief Summary
|
Purpose of study:comparing two doses of a drug called magnesium
sulphate given through vein and
determining which is effective for treating a severe case of asthma in children of 2 to 5 years of age.
- Procedure/methods of the study: If your
child is 2 to 5 years of age with severe breathing difficulty due to asthma
initial emergency treatment will be given and again condition will be
reassessed. If breathing difficulty is still severe, your child will be
enrolled in the study and be given a drug called magnesium sulphate injection
will be given. Your child will be allotted to one group randomly among the two
research groups. For one group 25mg/kg dose of drug will be given. Other group
will receive 50mg/kg. As a parent you will not know the dose of drug that is
administered. Condition will be assessed at every hour till four hours. Even at
the end of four hours if the respiratory difficulty is not improving then your
child`s treatment will be intensified as per your treating doctor in a
intensive care setting. |