The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
Purpose
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
- Extubation Failure
- Bronchopulmonary Dysplasia
- Death
Eligibility
- Eligible Ages
- Between 0 Days and 9 Weeks
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
- Masking Description
- Trial PIs are unaware of treatment allocation for individual subjects
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NIV-NAVA |
|
|
|
Active Comparator NS- NIPPV |
|
Recruiting Locations
Little Rock 4119403, Arkansas 4099753 72202
San Diego 5391811, California 5332921 92123
Hollywood 4158928, Florida 4155751 33021
Indianapolis 4259418, Indiana 4921868 46260
Louisville 4299276, Kentucky 6254925 40202
Kansas City 4393217, Missouri 4398678 64108
St Louis 4407066, Missouri 4398678 63110
Roa Rakesh
Voorhees Township 5105860, New Jersey 5101760 08043
Sarvin Ghavam
Columbus 4509177, Ohio 5165418 43205
Matthew Kielt
Philadelphia 4560349, Pennsylvania 6254927 19104
Murray 5778755, Utah 5549030 84107
Provo 5780026, Utah 5549030 84604
Bradley Yoder
Richmond 4781708, Virginia 6254928 23219
More Details
- NCT ID
- NCT05446272
- Status
- Recruiting
- Sponsor
- University of Pennsylvania
Detailed Description
Bronchopulmonary dysplasia (BPD) is the most common complication of prematurity and is the leading respiratory cause of childhood morbidity. Ventilator induced lung injury (VILI) an accepted and important contributor to BPD. Exposure to oxygen and positive pressure ventilation leads to developmental arrest and parenchymal injury in the immature preterm lung. Because even brief exposure to intubated positive pressure ventilation is injurious, avoiding invasive mechanical ventilation is the most widely acknowledged strategy to prevent VILI and the long-term sequela of BPD. Therefore, time on ventilators and rates of successful extubation are important endpoints of therapy. Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is an FDA approved technology that consistently synchronizes non-invasive respiratory support with infant respiratory drive. The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial is an unblinded, pragmatic, multicenter phase III randomized clinical trial in extremely preterm infants 23 0/7- 28 6/7 weeks gestational age to determine if NIV-NAVA, compared with non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV), prevents extubation failure within 5 days (120 hours) of extubation from mechanical ventilation