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

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ClinicalTrials.gov Identifier: NCT03492307
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
South Shore Hospital
Information provided by (Responsible Party):
Alla Smith, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Other: Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute) Other: Standard Flow for HFNC (Maximum 8L/minute) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weight-based Flow Rates for Children With Bronchiolitis on High-Flow Nasal Cannula: A Pilot Randomized Control Trial
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: Standard Flow Protocol
Patients randomized to this arm will receive HFNC according to our current protocol with a maximum of 8L/min.
Other: Standard Flow for HFNC (Maximum 8L/minute)
Maximum flow of 8L/minute.

Experimental: Weight-Based Flow Protocol
Patients randomized to this arm will receive HFNC according to a weight-based algorithm at 2L/kg/min.
Other: Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute)
A weight-based flow for HFNC.




Primary Outcome Measures :
  1. Treatment failure [ Time Frame: During hospital admission ]
    Need for escalation to NIV (CPAP or BIPAP) or intubation

  2. Length of Stay [ Time Frame: During hospital admission ]
    Length of hospital stay (admission to discharge or transfer)



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03492307


Contacts
Contact: Alla L Smith, MD 443-744-1610 alla.smith@childrens.harvard.edu

Locations
United States, Massachusetts
South Shore Hospital Recruiting
Weymouth, Massachusetts, United States, 02190
Contact: Alla Smith, MD         
Sponsors and Collaborators
Boston Children’s Hospital
South Shore Hospital
Investigators
Principal Investigator: Alla Smith, MD Boston Children’s Hospital

Responsible Party: Alla Smith, Principal Investigator, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03492307     History of Changes
Other Study ID Numbers: IRB-P00028533
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
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

Keywords provided by Alla Smith, Boston Children’s Hospital:
High Flow Nasal Cannula

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections