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

NCT04274192 | Terminated Results FDA Device

• 1 other identifier: 239863
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Work of Breathing

  estimated using swing Edi

  15 minutes

Secondary Outcomes (6)

• Thoracoabdominal Asynchrony

  15 minutes

• Uncalibrated Tidal Volume

  15 minutes

• FiO2 Requirement

  15 minutes

• Oxygen Saturation

  15 minutes

• Transcutaneous Oxygen Level

  15 minutes

Study Arms (2)

Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with synchronized)

EXPERIMENTAL

Subjects will first receive HFNC synchronized to his/her own efforts via NAVA at 6 LPM followed by continuous HFNC at 6 LPM and then HFNC synchronized to his/her own efforts via NAVA at 8 LPM followed by continuous HFNC at 8 LPM

Other: Synchronized HFNC at 6 liters per minute (LPM); Other: Continuous HFNC at 6 liters per minute (LPM); Other: Synchronized HFNC at 8 liters per minute (LPM); Other: Continuous HFNC at 8 liters per minute (LPM)

Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with continuous)

ACTIVE COMPARATOR

Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM. Next, subjects will receive continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM.

Other: Synchronized HFNC at 6 liters per minute (LPM); Other: Continuous HFNC at 6 liters per minute (LPM); Other: Synchronized HFNC at 8 liters per minute (LPM); Other: Continuous HFNC at 8 liters per minute (LPM)

Interventions

Synchronized HFNC at 6 liters per minute (LPM) OTHER

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

Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with continuous); Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with synchronized)

Continuous HFNC at 6 liters per minute (LPM) OTHER

Standard HFNC therapy at 6 LPM

Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with continuous); Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with synchronized)

Synchronized HFNC at 8 liters per minute (LPM) OTHER

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

Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with continuous); Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with synchronized)

Continuous HFNC at 8 liters per minute (LPM) OTHER

Standard HFNC therapy at 8 LPM

Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with continuous); Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with synchronized)

Eligibility Criteria

• Age: 28 Days - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Chronological age greater than 28 days
• Gestational age at birth less than 32 weeks and 6 days
• Diagnosis of BPD (supplemental oxygen requirement for greater than or equal to 28 days)
• Currently receiving noninvasive ventilation support (NIV NAVA, NIPPV, nCPAP, HFNC)

You may not qualify if:

• Major congenital anomalies of the heart and lungs
• Post menstrual age greater than 50 weeks 0 days
• Oxygen requirement greater than 40%

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

Using the equipment available, we were unable to administer the 6 LPM (per the protocol), so this subject did not receive all of the interventions and therefore did not complete the study. We subsequently terminated the study due to lack of protocol feasibility and the departure of the original PI.

Results Point of Contact

• Title: Dr. Sherry Courtney
• Organization: University of Arkansas for Medical Sciences

SECourtney@uams.edu

501-364-1028

Study Officials

• Sherry E Courtney, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: February 18, 2020
• Study Start: December 9, 2020
• Primary Completion: January 28, 2021
• Study Completion: January 28, 2021
• Last Updated: May 5, 2022
• Results First Posted: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)