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The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
Sponsor: University of Pennsylvania
Summary
DIVA is a pragmatic randomized clinical trial (RCT) to determine: among (P) preterm infants born 23 0/7-28 6/7 weeks gestation undergoing extubation from mechanical ventilation, whether (I) Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) (C) compared with Non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV), will reduce the incidence of (O) extubation failure within (T) 5 days (120 hours) of extubation.
Key Details
Gender
All
Age Range
0 Days - 9 Weeks
Study Type
INTERVENTIONAL
Enrollment
478
Start Date
2022-08-03
Completion Date
2027-03-31
Last Updated
2025-10-07
Healthy Volunteers
No
Interventions
NIV-NAVA
Infants in the intervention arm will be managed with non-invasive neurally adjusted ventilatory assist (NIV-NAVA) using FDA-approved servos with associated FDA-approved Edi catheter.
NS-NIPPV
Infants in the active comparator arm will be treated with non-synchronized non-invasive positive pressure ventilation (NIPPV) through FDA-approved ventilators currently in use at each site.
Locations (20)
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Loma Linda University
Loma Linda, California, United States
Sharp Mary Birch
San Diego, California, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
AdventHealth
Orlando, Florida, United States
Peyton Manning Children's Hospital
Indianapolis, Indiana, United States
Norton Children's Hospital
Louisville, Kentucky, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Washington University in St.Louis
St Louis, Missouri, United States
Virtua Vorhees Hospital
Voorhees Township, New Jersey, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
Atrial Health Brenner Children's Hospital( Wake Forest)
Winston-Salem, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Intermountain Medical Center
Murray, Utah, United States
Utah Valley Hospital
Provo, Utah, United States
Children's Hospital of Richmond
Richmond, Virginia, United States
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Mt Sinai Hospital
Toronto, Canada
BC Children's and Women's Hospital
Vancouver, Canada