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

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03492307
• Collaborator: South Shore Hospital (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 23
• Patients Per Site Per Month: 2.6

Study Details

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.

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)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 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
• Actual Primary Completion Date: Mar 30, 2020
• Actual Study Completion Date: Mar 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Treatment failure [During hospital admission]

   Need for escalation to NIV (CPAP or BIPAP) or intubation

2. Length of Stay [During hospital admission]

   Length of hospital stay (admission to discharge or transfer)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 2 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Shore Hospital	Weymouth	Massachusetts	United States	02190

Sponsors and Collaborators

• Boston Children's Hospital
• South Shore Hospital

Investigators

• Principal Investigator: Alla Smith, MD, Boston Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alla Smith, Principal Investigator, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT03492307
• Other Study ID Numbers: IRB-P00028533
• First Posted: Apr 10, 2018
• Last Update Posted: Jul 29, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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, Principal Investigator, Boston Children's Hospital: High Flow Nasal Cannula
• Additional relevant MeSH terms: Bronchiolitis

Study Results

No Results Posted as of Jul 29, 2021