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NAVA vs. CMV Crossover in Severe BPD

NCT04821453 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-05-20

Study results available
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Summary

This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and neurally adjusted ventilatory assist (NAVA) among 20 prematurely born infants and young children receiving invasive respiratory support for severe bronchopulmonary dysplasia (BPD).

Conditions

  • Bronchopulmonary Dysplasia
  • Neurally Adjusted Ventilatory Assist
  • Mechanical Ventilation

Interventions

DEVICE

NAVA

NAVA mode of mechanical ventilation provide the trigger for a spontaneous breath from the diaphragmatic movement instead of diaphragm and allows the patient to control the dynamics of the breath generally set in CMV mode.

DEVICE

CMV

CMV mode of mechanical ventilation that provides a trigger for a spontaneous breath from the airway flow sensor with dynamics of the breath set as required by the mode

Sponsors & Collaborators

  • Rhode Island Hospital

    collaborator OTHER

  • Children's Miracle Network

    collaborator OTHER

  • American Respiratory Care Foundation

    collaborator UNKNOWN

  • Children's Hospital of Philadelphia

    lead OTHER

Principal Investigators

  • Erik Jensen, MD, MSCE · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-13
Primary Completion
2024-11-08
Completion
2025-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04821453 on ClinicalTrials.gov