TERMINATED

NAVA vs. CMV Crossover in Severe BPD

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Conditions

Bronchopulmonary DysplasiaNeurally Adjusted Ventilatory AssistMechanical VentilationBPD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Pilot Cross-Over Trial of Neurally Adjusted Ventilatory Assist (NAVA) and Conventional Flow Triggered Mechanical Ventilation (CMV) in Severe Bronchopulmonary Dysplasia (sBPD)

Quick Facts

Study Start:2021-09-13
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04821453

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 24 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Gestational ages (GA) ≤ 32 weeks
  2. 2. Current age between 36 weeks postmenstrual age (PMA) and 2 years corrected age
  3. 3. Severe BPD \[as per National Institutes of Health (NIH) consensus definition\] diagnosed at 36 weeks postmenstrual age
  4. 4. Receiving invasive mechanical ventilation for ongoing lung disease
  5. 5. Not expected to be ready for extubation within 11 days following enrollment
  6. 6. Parental consent
  1. 1. Severe congenital anomalies
  2. 2. Known diaphragmatic defect
  3. 3. Current treatment with high frequency mechanical ventilation
  4. 4. Do not resuscitate (DNR) Status or Futility of Care
  5. 5. \>10% leak around the artificial airway,
  6. 6. Treatment with neuromuscular blockade within 72 hours prior to enrollment
  7. 7. Acute respiratory instability defined as a ventilator rate increase \> 15 beats per minute (bpm), Positive end-expiratory pressure (PEEP) increase \> 2 cm/water (H2O), sustained FiO2 increase \> 20%, and/or prescribed increase in tidal volume \> 2 mL/kg within 24 hours prior to enrollment will be excluded.

Contacts and Locations

Principal Investigator

Erik Jensen, MD, MSCE
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Rhode Island Hospital (Hasboro Children's Hospital)
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-13
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2021-09-13
Study Completion Date2025-02-28

Terms related to this study

Keywords Provided by Researchers

  • BPD
  • Bronchopulmonary Dysplasia

Additional Relevant MeSH Terms

  • Bronchopulmonary Dysplasia
  • Neurally Adjusted Ventilatory Assist
  • Mechanical Ventilation