High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study

NCT04517344 | Terminated

• 1 other identifier: STU-2020-0816
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

Bronchiolitis; HFNC; High Flow Nasal Cannula; Infants

Outcome Measures

Primary Outcomes (1)

• Treatment response to HFNC 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.

  4 hours of therapy

Secondary Outcomes (3)

• Treatment failure to HFNC Therapy

  24 hours from time of study

• Length of oxygen support

  24 hours from time of study

• Length of stay

  24 hours from time of study

Study Arms (3)

Arm 1, HFNC 1 L/kg/min

EXPERIMENTAL

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

Arm 2, HFNC 1.5 L/kg/min

EXPERIMENTAL

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

Arm 3, HFNC 2 L/kg/min

EXPERIMENTAL

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

Interventions

Initial Flow Rate OTHER

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

Arm 1, HFNC 1 L/kg/min; Arm 2, HFNC 1.5 L/kg/min; Arm 3, HFNC 2 L/kg/min

Eligibility Criteria

• Age: 7 Days - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Children's Health - Children's Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Amy Cheng, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 15, 2020
• First Posted: August 18, 2020
• Study Start: December 1, 2020
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)