Actively Recruiting
The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
Led by University of Pennsylvania · Updated on 2025-10-07
478
Participants Needed
20
Research Sites
243 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Major congenital anomalies, including pulmonary hypoplasia
- Neurologic disorders affecting respiratory drive (other than apnea of prematurity)
- Esophageal bleeding or other contraindication to NG/OG catheter placement
- Current weight <500 grams (based on Edi catheter approval)
- Study ventilator not available at time eligibility criteria are met
- Planned surgery or invasive procedure within 5 days of extubation
- Informed consent not provided
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
2
Loma Linda University
Loma Linda, California, United States, 92350
Terminated
3
Sharp Mary Birch
San Diego, California, United States, 92123
Actively Recruiting
4
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
5
AdventHealth
Orlando, Florida, United States, 32803
Actively Recruiting
6
Peyton Manning Children's Hospital
Indianapolis, Indiana, United States, 46260
Actively Recruiting
7
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
8
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
9
Washington University in St.Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
10
Virtua Vorhees Hospital
Voorhees Township, New Jersey, United States, 08043
Actively Recruiting
11
Levine Children's Hospital
Charlotte, North Carolina, United States, 28203
Actively Recruiting
12
Atrial Health Brenner Children's Hospital( Wake Forest)
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
13
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
14
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
15
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
16
Utah Valley Hospital
Provo, Utah, United States, 84604
Actively Recruiting
17
Children's Hospital of Richmond
Richmond, Virginia, United States, 23219
Actively Recruiting
18
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
19
Mt Sinai Hospital
Toronto, Canada, ON M5G 1X5
Actively Recruiting
20
BC Children's and Women's Hospital
Vancouver, Canada, BC V6H 3N1
Actively Recruiting
Research Team
E
Elizabeth Foglia
CONTACT
L
Lisa Wesby, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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