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CTRI Number  CTRI/2024/10/074815 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 28/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Efficacy of 3% hypertonic saline in the mangement of acute bronchiolitis.]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARITIVE EFFICACY OF HUMIDIFIED OXYGEN THERAPY VERSUS HUMIIDIFIED OXYGEN THERAPY ALONG WITH NEBULISED 3% HYPERTONIC SALINE IN CHILDREN WITH ACUTE BRONCHIOLITIS 
Scientific Title of Study   COMPARITIVE EFFICACY OF HUMIDIFIED OXYGEN THERAPY VERSUS HUMIIDIFIED OXYGEN THERAPY ALONG WITH NEBULISED 3% HYPERTONIC SALINE IN CHILDREN WITH ACUTE BRONCHIOLITIS-A RANDOMISED CONTROL 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 SHERIN J K  
Designation  JUNIOR RESIDENT, DEPARTMENT OF PAEDIATRICS 
Affiliation  MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE  
Address  DEPARTMENT OF PEDIATRICS MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE,KOLLENCHERRY,ERNAKULAM,682311
MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE,KOLENCHERRY,ERNAKULAM,682311
Ernakulam
KERALA
682311
India 
Phone  8113800335  
Fax    
Email  sherinjaicob15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SHERIN J K  
Designation  JUNIOR RESIDENT, DEPARTMENT OF PAEDIATRICS 
Affiliation  MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE  
Address  DEPARTMENT OF PEDIATRICS MALANKARA OETHODOX SYRIAN CHURCH MEDICAL COLLEGE,KOLLENCHERRY,682311
MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE,KOLENCHERRY,ERNAKULAM,682311
Ernakulam
KERALA
682311
India 
Phone  8113800335  
Fax    
Email  sherinjaicob15@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SHERIN J K  
Designation  JUNIOR RESIDENT, DEPARTMENT OF PAEDIATRICS 
Affiliation  MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE  
Address  DEPARTMENT OF PEDIATRICS MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE,KOLLENCHERRY,ERNAKULAM,682311
MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE,KOLENCHERRY,ERNAKULAM,682311
Ernakulam
KERALA
682311
India 
Phone  8113800335  
Fax    
Email  sherinjaicob15@gmail.com  
 
Source of Monetary or Material Support  
MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE HOSPITAL, KOLLENCHERRY,ERNAKULAM 
 
Primary Sponsor  
Name  MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE HOSPITAL 
Address  KOLLENCHERRY,ERNAKULAM 682311 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SHERIN J K   MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE HOSPITAL  DEPARTMENT OF PEDIATRICS MOSC MEDICAL COLLEGE
Ernakulam
KERALA 		 8113800335

sherinjaicob15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J219||Acute bronchiolitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Humidified oxygen in acute bronchiolitis  Humidified oxygen will be delivered to all children till achieve a SPO2 more than 95% through oxygen hood after mixing air and oxygen in a chamber containing sterile water for 4 hours per day.Daily assessment chart which includes patient information,clinical severity score and duration of oxygen therapy in hours will be documented from day 1 to day 5 of hospital admission after morning rounds.Clinical severity score is a scoring system ranging from 1- 12 which includes respiratory rate,wheezing,retraction and general condition of the child as parameters to assess the improvement in child’s condition.Usually moderate bronchiolitis patients requires hospital admission for an average of 4- 6 days;hence we documented clinical severity score and oxygen administration till 5 day. 
Intervention  Humidified oxygen therapy with add on 3% hypertonic saline in acute bronchioitis  Humidified oxygen therapy with add on 3% hypertonic saline(4ml 3 % hypertonic saline 8 hours apart) in the treatment of acute bronchiolitis.Daily assessment chart which includes patient information,clinical severity score and duration of oxygen therapy in hours will be documented from day 1 to day 5 of hospital admission after morning rounds.Clinical severity score is a scoring system ranging from 1- 12 which includes respiratory rate,wheezing,retraction and general condition of the child as parameters to assess the improvement in child’s condition.Usually moderate bronchiolitis patients requires hospital admission for an average of 4- 6 days;hence we documented clinical severity score and oxygen administration till 5 day 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  2.00 Year(s)
Gender  Both 
Details  All children of age group 2months to 2years with moderate bronchiolitis with SpO2 less than 92percentage correctable with oxygen whose parents gave informed consent 
 
ExclusionCriteria 
Details  1.Children previously diagnosed with chronic respiratory disease, cardiac disease and immunodeficiency
2.Children with previous wheezing episode.
3.Premature babies less than 34 weeks of gestation.
4.Mild and severe bronchiolitis. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clinical severity score and duration of oxygen therapy will be used to assess improvement and outcome of the study. Clinical severity score ranging from 1 to 3 are taken as mild, score 4 to 8 as moderate and score more than 8 as severe respiratory distress. Total duration of oxygen therapy will be calculated. Lower the duration of oxygen therapy implies better the treatment modality  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
data recorded in the prestructured proforma & daily assessment chart will be collected & analysed using SPSS software  4 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/11/2024 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   THIS IS A RANDOMISED CONTROL TRIAL COMPARING EFFICACY OF HUMIDIFIES OXYGEN THERAPY VERSUS HUMIDIFIED OXYGEN THERAPY ALONG WITH NEBULISED 3 PERCENTAGE HYPERTONIC SALINE IN CHILDREN WITH ACUTE BRONCHIOLITIS. THE PRESENT STUDY HYPOTHESIZED THAT SIMPLY INHALATION OF HYPERTONIC SALINE SOLUTION WITH HUMIDIFIED OXYGEN THERAPY IN BABIES WITH BRONCHIOLITIS MAY IMPROVE THERE CLINICAL SEVERITY SCORES THEREBY SHORTENING THE LENGTH OF HOSPITALISATION. 3 PERCENTAGE HYPERTONIC SALINE WILL REDUCE AIRWAY EDEMA  AND IMPROVE MUCOCILIARY FUNCTION BY ITS ABILITY TO LOWER THE VISCOSITY OF SECRETIONS.  
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