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

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiolitis; Respiratory Syncytial Virus (RSV)
• Intervention / Treatment: Device: Heated Humidified High Flow Nasal Cannula; Device: Standard Therapy (Low Flow Nasal Cannula)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khalid Alansari, MD; Phone Number: +974 55336166; Email: kalansari1@hamad.qa
• Study Contact Backup: Name: Maher M Najm, MD; Phone Number: +974 33165813; Email: dr.mmnajm@hotmail.com

Study Locations

• Qatar
  • Doha, Qatar
    • Recruiting
    • Alsadd Pediatric Emergency Center
    • Contact: Khalid Alansari, MD
    • Contact: Maher Najm, MD; Phone Number: 33165813; Email: dr.mmnajm@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Previously healthy infants with age 0-3 months and gestational age ≥30 weeks admitted to the short stay unit with RSV positive bronchiolitis and clinical severity score ≥4 on Wang clinical severity scale.

Exclusion Criteria:

1. Gestational age less than 30 weeks.
2. Previous history of wheezing.
3. Use of steroid within 48 hours of presentation.
4. History of chronic lung disease.
5. Infants admitted directly to ICU.
6. Prior invasive or non-invasive ventilatory support.
7. Tracheostomy.
8. Nasogastric tubes in situ on admission.
9. Upper airway abnormality (like choanal atresia and midfacial anomalies).
10. Immunodeficient children.
11. History of cardiac disease, renal disease or liver disease.
12. History of neuromuscular disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early use of HHHFNC; Heated Humidified High Flow Nasal Cannula	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
Active Comparator: Standard Therapy and Rescue HHHFNC; Low Flow Nasal Cannula only if the patient needs oxygenation and Rescue HHHFNC if the patient needs PICU	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of Pediatric Intensive Care Unit (PICU) admissions	The rate of Pediatric Intensive Care Unit admissions	Through study completion, an average of 3 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean length of stay (LOS)	Geometric mean length of stay in the short stay unit	Through study completion, an average of 3 year
Bronchiolitis Severity Score (BSS)	Bronchiolitis Severity Score at 4, 8, 12, 24, 36, 48, 72 hours	Up to 72 hours
Percentage of revisit, infirmary short-stay and admission to the hospital or PICU	Percentage of revisit, infirmary short-stay and admission to the hospital or PICU for the same illness on follow up for two weeks post discharge	2 weeks after discharge
Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2)	Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2) at 4,8,12,24,36,48,72 hours	Up to 72 hours
Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED	Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED	1 hour after starting of rescue HHHFNC

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation
• Collaborators: Sidra Medical and Research Center
• Investigators: Principal Investigator: Khalid Alansari, MD, Hamad Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2018
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Lung Diseases, Obstructive; Respiratory Syncytial Virus (RSV); Respiratory Failure; Bronchiolitis; High Flow Nasal Cannula (HFNC); Heated Humidified High Flow Nasal Cannula (HHHFNC); Low Flow Nasal Cannula
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 16036/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No