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Clinical Trials/CTRI/2025/08/093274
CTRI/2025/08/093274
Not yet recruiting
Phase 3

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.

JIPMER IMRF1 site in 1 country136 target enrollmentStarted: September 2, 2025Last updated:

Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
JIPMER IMRF
Enrollment
136
Locations
1
Primary Endpoint
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

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
1.00 Month(s) to 5.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All children aged one month to completed 5 years with clinical diagnosis of respiratory distress with respiratory assessment score of 6 or more.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor
JIPMER IMRF
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Sisira C R

JIPMER

Study Sites (1)

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