A Randomized Controlled Trial on the Efficacy of Heated Humidified High-Flow Nasal Cannula (HHHFNC) Driven Nebulization vs. Conventional Nebulization in children with Bronchiolitis
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Change in respiratory distress scores from baseline. (Downes score)
Study Overview
Brief Summary
Bronchiolitis is a common lower respiratory tract infection in infants and young children. It is leading cause of hospitalization in under 5 age group. It is commonly caused by viral infections such as Respiratory Syncytial Virus (RSV) and uncommonly by Human metapneumovirus, Rhinoviruses etc. It is characterized by bronchoconstriction, airway wall inflammation, increased mucus production and air flow obstruction. Nebulized bronchodilators and hypertonic saline are commonly used in the management of bronchiolitis. Heated humidified High-Flow Nasal Cannula (HHHFNC, hereafter referred to as HFNC) is a widely used non-invasive ventilatory support in children with bronchiolitis in the intensive care setting and has gained popularity as a respiratory support modality. Scarce data is available on HFNC use in the general pediatric ward and its effectiveness in delivering medications to the lower airways is under investigation for obstructive airway disease. This study aims to compare the efficacy of HFNC-driven nebulization with conventional nebulization in young children with bronchiolitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Day(s) to 2.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Infants and young children aged 0-2 years with bronchiolitis diagnosed clinically by physician supported by X-ray and laboratory investigations will be included.
Exclusion Criteria
- •Any patients requiring immediate respiratory support (non-invasive or invasive mechanical ventilation), altered mental status, or apnoea at presentation), those already admitted to the ICU due to respiratory failure, those with underlying chronic lung disease or cardiovascular disorders, those with obstructions of the upper respiratory tract, and those with cranial malformations will be excluded.
Outcomes
Primary Outcomes
Change in respiratory distress scores from baseline. (Downes score)
Time Frame: Duration of study : 12 to 18 months | No specified frequency, continued throughout the course of the individual treatment.
Secondary Outcomes
- Need for Escalation of respiratory support.
- Duration of hospital stay.
- Adverse events related to the nebulization technique.(12 to 18 months)
Investigators
Dr K Manikandan Arunasalam
Department of Paediatrics, Chettinad Hospital and Research Institute