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Clinical Trials/CTRI/2025/09/095219
CTRI/2025/09/095219
Not yet recruiting
Not Applicable

High Flow Nasal Cannula Therapy versus Traditional oxygen therapy on Healthcare resource utilisation in Bronchiolitis

Bhoomika Ganesh Hegde1 site in 1 country30 target enrollmentStarted: September 30, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Bhoomika Ganesh Hegde
Enrollment
30
Locations
1
Primary Endpoint
PICU Resource Utilization Score : We will compare mean and median NEMS scores between

Overview

Brief Summary

Acute respiratory distress is a leading cause of PICU admissions. Bronchiolitis is among the leading

causes of hospitalization for infants and young children worldwide. In India, seasonal outbreaks lead to a

surge of critically ill infants. Studies from tertiary centers in India report that over one-third of

hospitalized bronchiolitis cases requiring Paediatric admission. These critically ill infants frequently need

advanced respiratory support (e.g. non-invasive ventilation or intubation), contributing to prolonged

hospital stays (median ~5–6 days) and notable mortality (~8%) in severe cases1. This substantial disease

burden places significant strain on healthcare resources in resource-limited settings.Low- and middleincome

countries (LMICs) like India face constraints in critical care infrastructure – PICU beds,

ventilators, and trained personnel are limited relative to the paediatric population in need. Optimal

allocation of these resources is crucial.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
1.00 Month(s) to 2.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Children 1 month to 2 years of age admitted to Paediatrics department with acute bronchiolitis with Moderate to severe respiratory distress8 indicated by features such as SpO2 less than 92% on room air, persistent increased work of breathing (nasal flaring, intercostal retractions), apnea episodes, or need for frequent monitoring.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

PICU Resource Utilization Score : We will compare mean and median NEMS scores between

Time Frame: 18 months

groups as a quantitative outcome of resource use.

Time Frame: 18 months

Secondary Outcomes

  • Duration of Oxygen Therapy Total time the child remained on supplemental(oxygen of any kind. This ends when the child is weaned off O2 completely. A shorter oxygen)
  • Adverse events or Complications.Any notable complications related to oxygen therapy.(For HFNC nasal mucosal injury, epistaxis, abdominal distension and vomiting (from high flow), aspiration .)
  • Direct cost of treatment (exploratory) we will perform an approximate cost analysis using(hospital accounting data calculating oxygen consumption per patient (liters of Oxygen used, given)

Investigators

Sponsor
Bhoomika Ganesh Hegde
Sponsor Class
Other [myself]
Responsible Party
Principal Investigator
Principal Investigator

Dr Bhoomika Ganesh Hegde

Kmcri Hubli

Study Sites (1)

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