RecruitingNot ApplicableNCT05446272

The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial


Sponsor

University of Pennsylvania

Enrollment

478 participants

Start Date

Aug 3, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 0 DaysMax Age: 9 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called NIV-NAVA and a medical device called NS-NIPPV for people with bronchopulmonary dysplasia, death, and other related conditions. The study is currently recruiting participants at 20 locations. People eligible for this study include aged 0 Days to 9 Weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENIV-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.

DEVICENS-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

View Full Details on ClinicalTrials.gov

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NCT05446272


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