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Weight-based Flow Rates for Children With Bronchiolitis on High-Flow Nasal Cannula: A Pilot Randomized Control Trial

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute)
Standard Flow for HFNC (Maximum 8L/minute)
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring High Flow Nasal Cannula

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • admission to inpatient pediatrics
  • clinical diagnosis of bronchiolitis
  • BASS score of moderate or severe

Exclusion Criteria:

  • non-english speakers
  • patients with urgent need for CPAP, BIPAP or intubation

Sites / Locations

  • South Shore Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Flow Protocol

Weight-Based Flow Protocol

Arm Description

Patients randomized to this arm will receive HFNC according to our current protocol with a maximum of 8L/min.

Patients randomized to this arm will receive HFNC according to a weight-based algorithm at 2L/kg/min.

Outcomes

Primary Outcome Measures

Treatment failure
Need for escalation to NIV (CPAP or BIPAP) or intubation
Length of Stay
Length of hospital stay (admission to discharge or transfer)

Secondary Outcome Measures

Full Information

First Posted
April 3, 2018
Last Updated
July 27, 2021
Sponsor
Boston Children's Hospital
Collaborators
South Shore Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03492307
Brief Title
Weight-based Flow Rates for Children With Bronchiolitis on High-Flow Nasal Cannula: A Pilot Randomized Control Trial
Official Title
Weight-based Flow Rates for Children With Bronchiolitis on High-Flow Nasal Cannula: A Pilot Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
South Shore Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a pilot study comparing a weight-based high-flow nasal cannula (HFNC) protocol with the current standard HFNC protocol for children <2yo admitted to South Shore Hospital with bronchiolitis. We currently use a flat limit of 8 liters of HFNC to support work of breathing and hypoxia in these patients. We will compare that to a weight-based protocol, which will provide 2L/kg/min of flow (flows generally between 6 and 20L/minute) to this patient population. The goal of this pilot study is to assess the feasibility of our study design. We will evaluate the functionality of a new weight-based flow protocol. We will also evaluate the functionality of a new bronchiolitis scoring tool, the Bronchiolitis Assessment Severity Score (BASS), and it's ability to guide care through the new protocol. We are also testing the feasibility of recruitment, randomization and retention. We are ultimately interested in whether a weight-based flow protocol reduces need for escalation to ICU-level care for children with moderate-severe bronchiolitis on HFNC.
Detailed Description
This is a pilot study comparing a weight-based high-flow nasal cannula (HFNC) protocol with the current standard HFNC protocol for children <2yo admitted to South Shore Hospital with bronchiolitis. We currently use a flat limit of 8 liters of HFNC to support work of breathing and hypoxia in these patients. We will compare that to a weight-based protocol, which will provide 2L/kg/min of flow (flows generally between 6 and 20L/minute) to this patient population. The goal of this pilot study is to assess the feasibility of our study design. We will evaluate the functionality of a new weight-based flow protocol. We will also evaluate the functionality of a new bronchiolitis scoring tool, the Bronchiolitis Assessment Severity Score (BASS), and it's ability to guide care through the new protocol. We are also testing the feasibility of recruitment, randomization and retention. We are ultimately interested in whether a weight-based flow protocol reduces need for escalation to ICU-level care for children with moderate-severe bronchiolitis on HFNC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
High Flow Nasal Cannula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Flow Protocol
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm will receive HFNC according to our current protocol with a maximum of 8L/min.
Arm Title
Weight-Based Flow Protocol
Arm Type
Experimental
Arm Description
Patients randomized to this arm will receive HFNC according to a weight-based algorithm at 2L/kg/min.
Intervention Type
Other
Intervention Name(s)
Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute)
Intervention Description
A weight-based flow for HFNC.
Intervention Type
Other
Intervention Name(s)
Standard Flow for HFNC (Maximum 8L/minute)
Intervention Description
Maximum flow of 8L/minute.
Primary Outcome Measure Information:
Title
Treatment failure
Description
Need for escalation to NIV (CPAP or BIPAP) or intubation
Time Frame
During hospital admission
Title
Length of Stay
Description
Length of hospital stay (admission to discharge or transfer)
Time Frame
During hospital admission

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: admission to inpatient pediatrics clinical diagnosis of bronchiolitis BASS score of moderate or severe Exclusion Criteria: non-english speakers patients with urgent need for CPAP, BIPAP or intubation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alla Smith, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Shore Hospital
City
Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Weight-based Flow Rates for Children With Bronchiolitis on High-Flow Nasal Cannula: A Pilot Randomized Control Trial

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