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CTRI Number  CTRI/2025/08/093274 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 15/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of weaning from high flow nasal cannula versus direct transition to low flow nasal cannula in children age between 1 month to 5 years with respiratory distress in terms of improvement in respiratory rate and retraction. 
Scientific Title of Study   Comparison of weaning from high flow nasal cannula versus direct transition to nasal prong oxygen therapy in children with respiratory distress-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  Sisira C R 
Designation  Junior resident 
Affiliation  JIPMER 
Address  Department of pediatrics Jawaharlal Institute of postgraduate Medical Education and Research Gorimedu, Dhanvantari Nagar, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8594022595  
Fax    
Email  sisiracr1310@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tamilselvan  
Designation  Professor 
Affiliation  JIPMER 
Address  Department of pediatrics Jawaharlal Institute of postgraduate Medical Education and Research Gorimedu, Dhanvantari Nagar, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9916485716  
Fax    
Email  drselvantg@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Tamilselvan  
Designation  Professor 
Affiliation  JIPMER 
Address  Department of pediatrics Jawaharlal Institute of postgraduate Medical Education and Research Gorimedu, Dhanvantari Nagar, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9916485716  
Fax    
Email  drselvantg@yahoo.com  
 
Source of Monetary or Material Support  
JIPMER, IMRF FUND 
 
Primary Sponsor  
Name  JIPMER IMRF  
Address  Jawaharlal Institute of postgraduate Medical Education and Research Gorimedu, Dhanvantari Nagar, Pondicherry 
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 
Sisira C R  Jawaharlal Institute of postgraduate Medical Education and Research  Emergency room ward 167, High dependency room ward 466, Paediatric intensive care unit .Department of Paediatrics ,Jawaharlal Institute of postgraduate Medical Education and Research Gorimedu, Dhanvantari Nagar, Pondicherry
Pondicherry
PONDICHERRY 		 8594022595

sisiracr1310@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Interventional studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  children with respiratory distress with RAS score more than or equal to 6 will start HFNC and then wean  children with respiratory distress with RAS score more than or equal to 6 will start HFNC, will monitor the child. monitor assessment will be conducted at 0,1,3 hours there after every 6 hour till 24 hour then 12 hourly. weaning decision will take when RAS score become 4 or less and Fio2 40%. Then reduce FiO2 by 5% every 3hour until it becomes 21%. reduce the flow rate 10% until it becomes 0.5ml/kg/min 
Intervention  children with respiratory distress with RAS score more than or equal to 6 will start HFNC Then directly change to low flow nasal cannula oxygen therapy  children with respiratory distress with RAS score more than or equal to 6 will start HFNC, will monitor the child. monitor assessment will be conducted at 0,1,3 hours there after every 6 hour till 24 hour then 12 hourly. weaning decision will take when RAS score become 4 or less and Fio2 40%. Then directly change to low flow nasal prong oxygen therapy 4L/min 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  All children aged one month to completed 5 years with clinical diagnosis of respiratory distress with respiratory assessment score of 6 or more 
 
ExclusionCriteria 
Details  Children with hemodynamic instability
children who need mechanical ventilator support
children with known/suspected heart disease
children with known/suspected neuromuscular disorder
children with suspected upper airway obstruction or foreign body
children with suspected air leak
children with suspected intestinal obstruction
children receiving HFNC therapy via tracheostomy tube
children received HFNC within 1 month
children who weaned from mechanical ventilation to HFNC 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy between weaning from high flow nasal cannula & direct transition from high flow nasal cannula to nasal prong oxygen therapy in terms of improvement in respiratory assessment score in managing children aged 1 month (corrected) to 5 years (completed)with respiratory distress  To compare the efficacy between weaning from high flow nasal cannula & direct transition from high flow nasal cannula to nasal prong oxygen therapy in terms of improvement in respiratory assessment score in managing children aged 1 month (corrected) to 5 years (completed)with respiratory distress 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the following between weaning from high flow nasal cannula & direct transition from high flow nasal cannula to nasal prong oxygen therapy in terms of improvement in respiratory assessment score in managing children aged 1 month (corrected) to 5 years (completed)with respiratory distress
to compare the need for invasive mechanical ventilation
to compare length of hospital stay
to compare the factors associated with failure
to compare the adverse events 		 From day 1 of hospital stay till discharge  
 
Target Sample Size   Total Sample Size="136"
Sample Size from India="136" 
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   Phase 3 
Date of First Enrollment (India)   02/09/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Although there are several studies regarding high flow nasal cannula efficiency, there is no consensus on starting maintenance and weaning methods. A deeper understanding of HFNC weaning is essential. As unnecessary slow weaning may prolong hospital stay .They are only few studies regarding weaning strategy. 
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