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HFNC Initiation Flow Rate Study

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ClinicalTrials.gov Identifier: NCT04517344
Recruitment Status : Active, not recruiting
First Posted : August 18, 2020
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Amy Cheng, University of Texas Southwestern Medical Center

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 to take 6 months over the Winter/Spring of 2020-2021. 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 by RDAI of 6 or more.15

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HFNC Initiation Flow Rate Study - A Single Center, Randomized Controlled, Feasibility Study
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

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 SpO2 is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %, with maximum FiO2 of 50%. If FiO2 requirement exceeds 50%, the patient will be excluded from the study.
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 %, with maximum FiO2 of 50%. If FiO2 exceeds 50% requirement, patient will be excluded from the study.
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 %, with maximum FiO2 of 50%. If FiO2 exceeds 50% requirement, patient will be excluded from the study.
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




Primary Outcome Measures :
  1. Treatment response to HFNC Therapy [ Time Frame: 4 hours of therapy ]
    The primary outcome is treatment response to HFNC therapy defined by Respiratory Distress Assessment Instrument (RDAI)/Respiratory Assessment Change Score (RACS) ≥ 4. RDAI and RACS are scoring tools used to measure bronchiolitis severity and assess treatment response in clinical trials. The RDAI score (0-17) assigns a score based on RR and the extent of wheezing and retractions. A higher score is associated with more severe bronchiolitis. RACS was developed along with RDAI to assess the change from one point in time to another.



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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients less than 12 months of age with: (1) clinical signs of bronchiolitis defined by AAP and (2) respiratory distress defined by RDAI score 6 or greater.

Exclusion Criteria:

  • Infants who required immediate need for respiratory support such as non-invasive positive pressure ventilation (NIPPV) or invasive ventilation, or with congenital heart disease, immunocompromise, upper airway obstruction, chronic lung disease, bronchopulmonary dysplasia, infants on home oxygen therapy basilar skull fracture, facial traumas, craniofacial malformations, and infants admitted to the neonatal or cardiac ICUs. Patients who have received bronchodilator or steroid treatments are not excluded as previous studies have not shown these treatments to be effective in bronchiolitis management.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517344


Locations
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United States, Texas
Children's Health - Children's Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Amy Cheng, MD University of Texas Southwestern Medical Center
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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    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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