The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
- Conditions
- Extubation FailureBronchopulmonary DysplasiaDeath
- Interventions
- Device: NIV-NAVADevice: NS-NIPPV
- Registration Number
- NCT05446272
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
DIVA is a pragmatic randomized clinical trial (RCT) to determine: among (P) preterm infants born 24-27 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.
- 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 240/7- 276/7 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 478
- Gestational age of 24-27 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 <28 days at time of extubation
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NIV-NAVA NIV-NAVA - NS- NIPPV NS-NIPPV -
- Primary Outcome Measures
Name Time Method Extubation failure within the first 5 days (120 hours) post extubation Extubation failure is defined when an infant is on the allocated mode of respiratory support and meets any of the following 4 criteria: (1) Rise in FiO2 at least 20% from pre-extubation value for \>2 hours to maintain local SpO2 targets, (2) pH ≤7.20 or pCO2 ≥70mm Hg; (3) \>1 apneic event requiring positive pressure ventilation (PPV) within 6 hours or ≥ 6 apneic events requiring stimulation within 6 hours (4) emergent intubation by the clinical team for cardiovascular instability or surgery.
- Secondary Outcome Measures
Name Time Method Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA 36 weeks PMA BPD will be assessed as an ordinal outcome (none, grade 1, 2, 3), according to the NRN criteria.
Death or BPD at 36 weeks PMA 36 weeks PMA Composite dichotomous (y/n) outcome of death or grade 2/3 BPD, using the NRN criteria
Endotracheal intubation through 36 weeks PMA 36 weeks PMA Endotracheal intubation will be assessed 2 ways: As a dichotomous (y/n) outcome if it occurs at any time and also as days until endotracheal intubation (with censoring at 36 weeks PMA)
Postmenstrual age at last supplemental oxygen 36 weeks PMA Time to cessation of supplemental oxygen, with censoring at 36 weeks PMA
Postmenstrual age at last invasive ventilation 36 weeks PMA Time to cessation of invasive ventilation, with censoring at 36 weeks PMA
Postmenstrual age at last positive pressure support 36 weeks PMA Time to cessation of positive pressure respiratory support, with censoring at 36 weeks PMA
Prematurity-related morbidities through 36 weeks PMA 36 weeks PMA Brain injury (intraventricular hemorrhage and periventricular leukomalacia), patent ductus arteriosus requiring therapy, pulmonary hemorrhage, culture proven sepsis, necrotizing enterocolitis, retinopathy of prematurity
Trial Locations
- Locations (20)
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, 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
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
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
Washington University in St.Louis
🇺🇸Saint Louis, Missouri, United States
Virtua Vorhees Hospital
🇺🇸Voorhees, New Jersey, 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
Mt Sinai Hospital
🇨🇦Toronto, Canada
BC Children's and Women's Hospital
🇨🇦Vancouver, Canada