| CTRI Number |
CTRI/2010/091/000080 [Registered on: 21/07/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO STUDY THE UTILITY OF HYPERTONIC SALINE NEBULIZER IN MANAGEMENT OF ACUTE BRONCHIOLITIS AND ITS SIDE EFFECTS. |
|
Scientific Title of Study
|
UTILITY OF HYPERTONIC SALINE IN MANAGEMENT OF ACUTE BRONCHIOLITIS IN INFANTS |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR.NEERAJ DHAWAN |
| Designation |
|
| Affiliation |
|
| Address |
Medical Officer, Pediatrics Dept.Govt. MultiSpeciality Hospital,Sec-16,Chandigarh
Chandigarh
CHANDIGARH
110015
India |
| Phone |
0172 2731002 |
| Fax |
|
| Email |
ndhawan_6144@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.NEERAJ DHAWAN |
| Designation |
|
| Affiliation |
|
| Address |
Medical Officer, Pediatrics Dept.Govt. MultiSpeciality Hospital,Sec-16,Chandigarh
Chandigarh
CHANDIGARH
110015
India |
| Phone |
0172 2731002 |
| Fax |
|
| Email |
ndhawan_6144@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Thakur |
| Designation |
|
| Affiliation |
|
| Address |
Pediatrics Dept. Govt. Multispeciality Hospital,Sec-16,Chandigarh
Chandigarh
CHANDIGARH
110015
India |
| Phone |
0172 2768247 |
| Fax |
|
| Email |
deepak_130505@yahoo.com |
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Source of Monetary or Material Support
|
| GOVERNMENT MULTISPECIALITY HOSPITAL,SEC-16,CHANDIGARH, INDIA |
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Primary Sponsor
|
| Name |
Dr Neeraj Dhawan |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
|
| Name |
Address |
| Dr Praveena Dhiman |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sadbhavna Pandit |
SMO, Pediatrics Dept. Govt. MultiSpeciality Hospital Sec 16, Chandigarh |
,-160015
Chandigarh
CHANDIGARH |
0172 2768248
p.sadbhavna@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THESIS ETHICAL COMMITTEE, GOVT. MULTISPECIALITY HOSPITAL,SEC-16,CHANDIGARH |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ACUTE BRONCHIOLITIS, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hypertonic saline (3%) and Adrenalin |
4 ml hypertonic saline and 1 ml adrenalin given as nebulizer 1 hourly at admission and then 6 hrly till discharge. |
| Comparator Agent |
Normal saline and Adrenalin |
4 ml normal saline and 1 ml Adrenalin as nebulizer 1 hourly at admission and then 6 hourly till discharge. |
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Inclusion Criteria
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| Age From |
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| Age To |
|
| Gender |
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| Details |
Infants between the age group of two month to twelve months and admitted with clinical diagnosis of acute bronchiolitis. |
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| ExclusionCriteria |
| Details |
1.patient with recurrent episodes of wheezing, one or more episodes of respiratory distress in past
2.patients with family history of asthma,atopy.
3.presence of congenital heart disease.
4. history of prematurity and mechanical ventilation in newborn period.
5.very sick patients with shock, seizures, heart rate>180/min,respiratory rate of >100/min and adjudged to be in incipient resp. faliure.
6.grade 3 and 4 PEM
7.consolidation lung on x-ray chest.
8.foreingn body aspiration.
9.no child will be included in the study twice. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| length of hospital stay. |
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Secondary Outcome
|
| Outcome |
TimePoints |
| 1.improvement in RDAI score.
2. respiratory rate.
3.haemoglobin saturation.
4.heart rate.
5.number of add on treatment.
6.adverse events(tachycardia,pallor,tremor,nausea,vomiting) |
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 2/ Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/11/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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THIS STUDY IS A RANDOMIZED,DOUBLE-BLIND,CONTROLLED TRIAL TO STUDY THE EFFICACY AND SAFETY OF HYPERTONIC SALINE WITH ADRENALINE IN ACUTE BRONCHIOLITIS. THE PRIMARY OUTCOME IS THE LENGTH OF STAY IN HOSPITAL AND SECONDRY IS IMPROVEMENT IN RDAI SCORE, RESPIRATORY RATE, HAEMOGLOBIN SATURATION. |