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Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD

NCT04274192 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-05-05

Study results available
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Summary

Patients will be randomized to begin the study with either NAVA-synchronized or continuous HFNC. Each patient will receive two 15-minute trials at different levels of continuous HFNC and two 15-minute trials at corresponding levels of synchronized HFNC. In synchronized HFNC, using the NIV NAVA mode on the ventilator each subject will receive a constant minimum flow, but with each neurally triggered breath (as measured with an Edi catheter), an additional flow will be given to the patient. This differs from continuous HFNC in which the subject receives a constant flow without variation. Subjects will be observed during the entirety of these trials. Values for the primary and secondary outcomes will be monitored, recorded, and calculated.

Conditions

  • Bronchopulmonary Dysplasia

Interventions

OTHER

Synchronized HFNC at 6 liters per minute (LPM)

HFNC given in synchrony with the subject's own respiratory effort using NAVA at 6 LPM

OTHER

Continuous HFNC at 6 liters per minute (LPM)

Standard HFNC therapy at 6 LPM

OTHER

Synchronized HFNC at 8 liters per minute (LPM)

HFNC given in synchrony with the subject's own respiratory effort using NAVA at 8 LPM

OTHER

Continuous HFNC at 8 liters per minute (LPM)

Standard HFNC therapy at 8 LPM

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Sherry E Courtney, MD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-09
Primary Completion
2021-01-28
Completion
2021-01-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04274192 on ClinicalTrials.gov