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

NCT03492307 | Completed

• 1 other identifier: IRB-P00028533
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

High Flow Nasal Cannula

Outcome Measures

Primary Outcomes (2)

• Treatment failure

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

  During hospital admission

• Length of Stay

  Length of hospital stay (admission to discharge or transfer)

  During hospital admission

Study Arms (2)

Standard Flow Protocol

ACTIVE COMPARATOR

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)

Weight-Based Flow Protocol

EXPERIMENTAL

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)

Interventions

Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute) OTHER

A weight-based flow for HFNC.

Weight-Based Flow Protocol

Standard Flow for HFNC (Maximum 8L/minute) OTHER

Maximum flow of 8L/minute.

Standard Flow Protocol

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• South Shore Hospital: collaborator

Study Sites (1)

South Shore Hospital

Weymouth, Massachusetts, 02190, United States

Location

Related Publications (1)

• Smith A, Banville D, O'Rourke C, Melvin P, Batey L, Borgmann A, Waltzman M, Agus MSD. Randomized Trial of Weight-Based Versus Fixed Limit High-Flow Nasal Cannula in Bronchiolitis. Hosp Pediatr. 2023 May 1;13(5):387-393. doi: 10.1542/hpeds.2022-006656.

  PMID: 37122050 DERIVED

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Alla Smith, MD

  Boston Children's Hospital

  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: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 10, 2018
• Study Start: May 1, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)