The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

NARecruitingINTERVENTIONAL
Enrollment

478

Participants

Timeline

Start Date

August 3, 2022

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2027

Conditions
Extubation FailureBronchopulmonary DysplasiaDeath
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (20)

19104

RECRUITING

Hospital of the University of Pennsylvania, Philadelphia

23219

RECRUITING

Children's Hospital of Richmond, Richmond

27157

RECRUITING

Atrial Health Brenner Children's Hospital( Wake Forest), Winston-Salem

28203

RECRUITING

Levine Children's Hospital, Charlotte

32803

RECRUITING

AdventHealth, Orlando

33021

RECRUITING

Joe DiMaggio Children's Hospital, Hollywood

40202

RECRUITING

Norton Children's Hospital, Louisville

43205

RECRUITING

Nationwide Children's Hospital, Columbus

46260

RECRUITING

Peyton Manning Children's Hospital, Indianapolis

63110

RECRUITING

Washington University in St.Louis, St Louis

64108

RECRUITING

Children's Mercy Hospital, Kansas City

72202

RECRUITING

Arkansas Children's Hospital, Little Rock

84107

RECRUITING

Intermountain Medical Center, Murray

84604

RECRUITING

Utah Valley Hospital, Provo

92123

RECRUITING

Sharp Mary Birch, San Diego

92350

TERMINATED

Loma Linda University, Loma Linda

08043

RECRUITING

Virtua Vorhees Hospital, Voorhees Township

M4N3M5

RECRUITING

Sunnybrook Health Sciences Centre, Toronto

ON M5G 1X5

RECRUITING

Mt Sinai Hospital, Toronto

BC V6H 3N1

RECRUITING

BC Children's and Women's Hospital, Vancouver

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

University of Pennsylvania

OTHER