NCT03095495

High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue

Heated Humidified High Flow Nasal Cannula (HHHFNC) For Acute Moderate to Severe RSV-Bronchiolitis in Infants Younger Than 3 Months Old: Early Versus Rescue

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Hamad Medical Corporation · Industry
• Sex: All
• Age: 3 Months
• Healthy volunteers: Not accepted

Summary

The enrolled RSV-bronchiolitis patients will be randomized into two arms , the early HHHFNC group and the standard therapy group with rescue HHHFNC to study the efficacy of this treatment.

Detailed description

Setting: The study will be conducted between June 2017 and June 2020 in the short stay unit of the Pediatric Emergency Center (PEC) of Hamad General Hospital, the only pediatric emergency facility in the State of Qatar. Infants aged ≤3 months presenting to the unit for treatment of viral bronchiolitis with positive RSV test will be eligible for the study. Procedure: Eligible patients will be enrolled after obtaining written consent. For patients who consent, plain chest radiography, and nasopharyngeal swabs will be taken for RSV detection. If the patient has a positive RSV rapid antigen test, patients will be randomized in one of the study arms. Adverse effects in each group will be carefully monitored and documented. Study Intervention: Patients will be randomized into two treatment arms Group 1: Early HHHFNC Group Patients in this group will be treated by using heated humidified high flow oxygen /air via nasal cannula; investigators will keep the patient on HHHFNC until he/she becomes clinically ready for discharge. Group 2: Standard Therapy and Rescue HHHFNC Group: patients in this group will be treated by usual therapy,investigators will use low flow nasal cannula oxygen therapy only if oxygenation needed to maintain Oxygen saturation (SpO2) ≥ 92% , if the patient deteriorate and require ICU, rescue HHHFNC will be started before admission to the ICU.

Conditions

• Bronchiolitis
• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
DEVICE	Heated Humidified High Flow Nasal Cannula	HHHFNC therapy is a simple to use system that delivers warm and moist air/oxygen mixture at high flow rates that generate positive airway pressure
DEVICE	Standard Therapy (Low Flow Nasal Cannula)	will be used only if the patient needs oxygenation and Rescue HHHFNC will be used if the patient needs PICU

Timeline

• Start date: 2018-08-14
• Primary completion: 2024-05-28
• Completion: 2024-05-28
• First posted: 2017-03-29
• Last updated: 2024-09-19

Locations

1 site across 1 country: Qatar