High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study

• ClinicalTrials.gov Identifier: NCT04517344
• Recruitment Status: Recruiting
• First Posted: August 18, 2020
• Last Update Posted: June 30, 2022
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Amy Cheng, University of Texas Southwestern Medical Center

Study Description

Brief Summary:

The investigators propose an open label, non-blinded, single center randomized controlled feasibility study to find the optimal initial HFNC flow rate in children less than 12 months old with clinically diagnosed moderate to severe bronchiolitis. This feasibility study is projected over December 2020 to April 2023. The study is consisted of 3 arms, comparing HFNC therapy at 1 L/kg/min, 1.5 L/kg/min, and 2 L/kg/min (20 L/min max). Moderate to severe bronchiolitis is defined clinician's assessment for the need for ICU level of care.

The primary outcome is treatment response to HFNC therapy defined by RDAI/Respiratory Assessment Change Score (RACS) ≥ 4 at 4 hours of therapy. Secondary outcome measures comprise of treatment failure requiring an escalation of care during the first 24 hours of HFNC therapy, duration of HFNC and simple nasal cannula therapy, duration of simple nasal cannula therapy, hospital and PICU length of stay (LOS), time to treatment failure, and adverse events.

Condition or disease	Intervention/treatment	Phase
Bronchiolitis	Other: Initial Flow Rate	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study - A Single Center, Randomized Controlled, Feasibility Study
• Actual Study Start Date: December 1, 2020
• Estimated Primary Completion Date: April 2023
• Estimated Study Completion Date: April 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1, HFNC 1 L/kg/min; The infant that is randomized to the HFNC therapy arm 1 will be placed on high flow at 1 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If oxygen saturation (SpO2) is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %.	Other: Initial Flow Rate; Patients placed on High Flow Nasal Cannula by treating physician will be randomized to initial flow rates of 1 L/kg/min, 1.5 L/kg/min, or 2 L/kg/min
Experimental: Arm 2, HFNC 1.5 L/kg/min; The infant that is randomized to the HFNC therapy arm 2 will be placed on high flow at 1.5 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If SpO2 is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %.	Other: Initial Flow Rate; Patients placed on High Flow Nasal Cannula by treating physician will be randomized to initial flow rates of 1 L/kg/min, 1.5 L/kg/min, or 2 L/kg/min
Experimental: Arm 3, HFNC 2 L/kg/min; The infant that is randomized to the HFNC therapy arm 3 will be placed on high flow at 2 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If SpO2 is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %.	Other: Initial Flow Rate; Patients placed on High Flow Nasal Cannula by treating physician will be randomized to initial flow rates of 1 L/kg/min, 1.5 L/kg/min, or 2 L/kg/min

Outcome Measures

Primary Outcome Measures :

1. Treatment response to HFNC Therapy [ Time Frame: 4 hours of therapy ]

   Determined by Respiratory Distress Assessment Instrument (RDAI) score and Respiratory Assessment Change Score (RACS) and heart rate improvement by 10%.

   The RDAI score assigns a score base on respiratory rate (RR), extent of wheezing, and retractions. It ranges from 0-17, higher score indicates severe bronchiolitis.

   To determine RACS:

   • A decrease in RR by 10% is +1 change unit. Increase of 10% was defined as -1 change unit.
   • Subsequent RDAI score is subtracted from the previous RDAI score to obtain the change. (ie. if initial score is 7 and the reassessment score is 3, the patient has a score of +4) Positive score is indicative of improvement, and negative score demonstrates deterioration.

   The overall RACS is calculated as the sum of change scores. Improvement is defined as RACS ≥ 4 positive units. No improvement was defined as RACS < 4 positive units.

Secondary Outcome Measures :

1. Treatment failure to HFNC Therapy [ Time Frame: 24 hours from time of study ]
   • Need for an increase in initial flow setting as determined by treating physician during the first 24 hours of hospitalization
   • Escalation to other forms of non-invasive ventilatory support (i.e. NCPAP or BIPAP)
   • Need for invasive ventilation
2. Length of oxygen support [ Time Frame: 24 hours from time of study ]
   • Number of hours on HFNC
   • Number of hours on simple nasal cannula
3. Length of stay [ Time Frame: 24 hours from time of study ]
   • Length of stay in the pediatric ICU
   • Length of stay in the hospital

Eligibility Criteria

• Ages Eligible for Study: 7 Days to 12 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients less than 12 months of age
• Clinical signs of moderate to severe bronchiolitis defined by American Academy of Pediatrics
• Requires ICU level of care by clinicians' discretion
• Requiring HFNC support

Exclusion Criteria:

• Infants who required immediate need for respiratory support such as non-invasive positive pressure ventilation (NIPPV) or invasive ventilation
• Congenital heart disease,
• Immunocompromised state
• Upper airway obstruction
• Chronic lung disease
• Bronchopulmonary dysplasia,
• Home oxygen therapy requirement
• Acute trauma patients
• Baseline craniofacial malformations
• Admitted to the neonatal or cardiac ICUs
• Patients who are admitted to the floor

Contacts and Locations

Contacts

Contact: Amy Cheng, MD; 615-481-7074; Amy.Cheng@UTSouthwestern.edu

Locations

United States, Texas

Children's Health - Children's Medical Center; Recruiting

Dallas, Texas, United States, 75235

Contact: Amy Cheng, MD 615-481-7074 Amy.Cheng@UTSouthwetern.edu

Contact: Gerald B Moody, BSRC 214-456-1367 gerald.moody@childrens.com

Principal Investigator: Amy Cheng, MD

Sub-Investigator: Gerald B Moody, BSCR

Sub-Investigator: Mia Maamari, MD

Sub-Investigator: Mohamed Badawy

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Amy Cheng, MD; University of Texas Southwestern Medical Center

More Information

• Responsible Party: Amy Cheng, Assistant Professor of Medicine, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT04517344
• Other Study ID Numbers: STU-2020-0816
• First Posted: August 18, 2020
• Last Update Posted: June 30, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Amy Cheng, University of Texas Southwestern Medical Center:

Bronchiolitis; HFNC; High Flow Nasal Cannula; Infants

Additional relevant MeSH terms:

Bronchiolitis; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases