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NCT03492307 · ClinicalTrials.gov registry record · NA

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

A NA study of Bronchiolitis, sponsored by Boston Children's Hospital.

Completed
Registry status
NA
Development phase
60
Enrollment target
1
Study location

NCT03492307 is a NA study of Bronchiolitis that has completed, run by Boston Children's Hospital. The registered enrollment target is 60 participants, below the 572-participant average among 12 other Bronchiolitis trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03492307, a NA study of Bronchiolitis, has completed, sponsored by Boston Children's Hospital.

COMPLETED
Registry status
NA
Development phase
60 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • OTHER Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute)
  • OTHER Standard Flow for HFNC (Maximum 8L/minute)

Study Locations (1)

Massachusetts

  • South Shore Hospital - Weymouth

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2018-05-01
Est. Completion 2020-03-30
Phase NA

Sponsor

Boston Children's Hospital

462 total trials

What the Registry Record Tells You About NCT03492307

The ClinicalTrials.gov registry entry for NCT03492307 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 572-participant average among 12 other Bronchiolitis trials with a reported enrollment target (90% lower). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Bronchiolitis appearing as the primary indexed condition, and to 2 interventions - of which Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute) is the first listed.

NCT03492307 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT03492307 about?

NCT03492307 is a clinical study titled "Weight-based Flow Rates for Children With Bronchiolitis on High-Flow Nasal Cannula: A Pilot Randomized Control Trial". 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 p...

What is the current status of trial NCT03492307?

This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2018-05-01. Estimated completion is 2020-03-30.

What conditions does trial NCT03492307 study?

This clinical trial studies the following conditions: Bronchiolitis.

What interventions are being tested in trial NCT03492307?

The interventions under investigation include: Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute) (OTHER), Standard Flow for HFNC (Maximum 8L/minute) (OTHER).

Who is sponsoring clinical trial NCT03492307?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03492307 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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