The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 2 months
Healthy Volunteers: f
View:

• Gestational age of 23 0/7- 28 6/7 weeks at birth

• Intubated in the first 7 days of life

• Undergoing extubation following at least 12 hours of invasive mechanical ventilation

• Post-natal age \<32 weeks Post menstrual age at time of extubation

Locations
United States
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
California
Loma Linda University
TERMINATED
Loma Linda
Sharp Mary Birch
RECRUITING
San Diego
Florida
Joe DiMaggio Children's Hospital
RECRUITING
Hollywood
AdventHealth
RECRUITING
Orlando
Indiana
Peyton Manning Children's Hospital
RECRUITING
Indianapolis
Kentucky
Norton Children's Hospital
RECRUITING
Louisville
Missouri
Children's Mercy Hospital
RECRUITING
Kansas City
Washington University in St.Louis
RECRUITING
St Louis
North Carolina
Levine Children's Hospital
RECRUITING
Charlotte
Atrial Health Brenner Children's Hospital( Wake Forest)
RECRUITING
Winston-salem
New Jersey
Virtua Vorhees Hospital
RECRUITING
Voorhees Township
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Utah
Intermountain Medical Center
RECRUITING
Murray
Utah Valley Hospital
RECRUITING
Provo
Virginia
Children's Hospital of Richmond
RECRUITING
Richmond
Other Locations
Canada
Mt Sinai Hospital
RECRUITING
Toronto
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
BC Children's and Women's Hospital
RECRUITING
Vancouver
Contact Information
Primary
Elizabeth Foglia
FOGLIA@email.chop.edu
267-441-7144
Backup
Lisa Wesby, MS
wesby@pennmedicine.upenn.edu
215-573-6318
Time Frame
Start Date: 2022-08-03
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 478
Treatments
Experimental: NIV-NAVA
Active_comparator: NS- NIPPV
Sponsors
Leads: University of Pennsylvania
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov