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CTRI Number  CTRI/2020/12/029648 [Registered on: 08/12/2020] Trial Registered Prospectively
Last Modified On: 07/12/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Clinical profile (details related to disease, treatment and response)of children who received High Frequency mode of ventilation for respiratory failure due to inadequate oxygen levels in post-OSCAR and OSCILLATE trials era 
Scientific Title of Study   Clinical profile of children who received high frequency ventilation for hypoxemic respiratory failure in post- OSCAR and OSCILLATE trials era 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr ANUPAMA YERRA 
Designation  Consultant Pediatric Intensivist 
Affiliation  RAINBOW CHILDRENS HOSPITAL 
Address  2nd FLOOR , PEDIATRIC INTENSIVE CARE UNIT , RAINBOW CHILDRENS HOSPITAL, ROAD NO.2 BANJARA HILLS, HYDERABAD
2nd FLOOR , PEDIATRIC INTENSIVE CARE UNIT , RAINBOW CHILDRENS HOSPITAL, ROAD NO.2 BANJARA HILLS, HYDERABAD
Hyderabad
TELANGANA
500034
India 
Phone  8008740697  
Fax    
Email  puttaanu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr ANUPAMA YERRA 
Designation  Consultant Pediatric Intensivist 
Affiliation  RAINBOW CHILDRENS HOSPITAL 
Address  2ND FLOOR, PEDIATRIC INTENSIVE CARE UNIT, RAINBOW CHILDRENS HOSPITAL, ROAD NO.2 BANJARA HILLS, HYDERABAD
2ND FLOOR, PEDIATRIC INTENSIVE CARE UNIT, RAINBOW CHILDRENS HOSPITAL, ROAD NO.2 BANJARA HILLS, HYDERABAD
Hyderabad
TELANGANA
500034
India 
Phone  8008740697  
Fax    
Email  puttaanu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr G ADITYA KIRAN 
Designation  PG STUDENT- DNB 
Affiliation  RAINBOW CHILDRENS HOSPITAL 
Address  2ND FLOOR, PEDIATRIC INTENSIVE CARE UNIT, RAINBOW CHILDRENS HOSPITAL, ROAD NO.2 BANJARA HILLS, HYDERABAD
2ND FLOOR, PEDIATRIC INTENSIVE CARE UNIT, RAINBOW CHILDRENS HOSPITAL, ROAD NO.2 BANJARA HILLS, HYDERABAD
Hyderabad
TELANGANA
500034
India 
Phone  7989251887  
Fax    
Email  gadityakiran457@gmail.com  
 
Source of Monetary or Material Support  
RAINBOW CHILDRENS HOSPITAL, ROAD NO.2 BANJARA HILLS, HYDERABAD, TELANGANA 
 
Primary Sponsor  
Name  DR ANUPAMA YERRA 
Address  RAINBOW CHILDRENS HOSPITAL, ROAD NO.2, BANJARA HILLS, HYDERABAD, TELANGANA 
Type of Sponsor  Other [SELF] 
 
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 ANUPAMA YERRA  RAINBOW CHILDRENS HOSPITAL  2ND FLOOR, DEPARTMENT OF PEDIATRIC INTENSIVE CARE UNIT, ROAD NO.2, BANJARA HILLS, HYDERABAD
Hyderabad
TELANGANA 		 8008740697

puttaanu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RAINBOW HOSPITAL INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J962||Acute and chronic respiratory failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All children aged between 1 month and 18 years with hypoxemic respiratory failure requiring high frequency oscillation ventilation 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare the clinical profile of children with hypoxemic respiratory failure who survived on high frequency ventilation with children with hypoxemic respiratory failure who died on high frequency ventilation  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
association of HFOV settings on outcome parameters like ventilator days, air leaks, hemodynamic instability, PICU stay, mortality  1 year 
possible outcome predictors for children with hypoxemic respiratory failure on HFOV  1 year 
association of cumulative fluid balance, renal angina index on outcome of children on HFOV  1 year 
association of proning maneuvers on the outcome of children on HFOV  1 year 
 
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)   10/12/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOT YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   THIS IS A SINGLE CENTRE, OBSERVATIONAL, STUDY WITH  RETROSPECTIVE STUDY PERIOD OF 3 TEAR DURATION ( SINCE JANUARY 2017) AND PROSPECTIVE STUDY OF 1 YEAR PERIOD WHICH AIMS TO STUDY THE CLINICAL PROFILES OF CHILDREN BETWEEN AGES 1 MONTH AND 18 YEARS WITH HYPOXEMIC RESPIRATORY FAILURE WHO RECEIVED HIGH-FREQUENCY VENTILATION WITH SECONDARY OBJECTIVES OF STUDYING THE ASSOCIATION OF HFOV SETTINGS ON MORTALITY, VENTILATION DAYS, PICU STAY, AIR LEAKS, HEMODYNAMIC INSTABILITY, TO INVESTIGATE POSSIBLE OUTCOME PREDICTORS FOR CHILDREN ON HFOV, TO STUDY ASSOCIATION OF CUMULATIVE FLUID BALANCE, RENAL ANGINAL INDEX, AND PRONING MANEUVERS ON THE OUTCOME OF CHILDREN ON HFOV. RETROSPECTIVE DATA OF LAST 3 YEARS (SINCE JANUARY 2017 WILL ALSO BE COLLECTED)  
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