The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NIV-NAVA, NS-NIPPV.
- Who it may be relevant to
- Registry conditions: Extubation Failure, Bronchopulmonary Dysplasia, Death. Basic parameters: 0 Days — 9 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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
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.
Primary outcome measures
- Extubation failure [Time frame: within the first 5 days (120 hours) post extubation]
Secondary outcome measures (7)
- Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA [Time frame: 36 weeks PMA]
- Death or BPD at 36 weeks PMA [Time frame: 36 weeks PMA]
- Endotracheal intubation through 36 weeks PMA [Time frame: 36 weeks PMA]
- Postmenstrual age at last invasive ventilation [Time frame: 36 weeks PMA]
- Postmenstrual age at last positive pressure support [Time frame: 36 weeks PMA]
- Postmenstrual age at last supplemental oxygen [Time frame: 36 weeks PMA]
- Prematurity-related morbidities through 36 weeks PMA [Time frame: 36 weeks PMA]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 17 centers
- Arkansas Children's Hospital — Little Rock
- Loma Linda University — Loma Linda
- Sharp Mary Birch — San Diego
- Joe DiMaggio Children's Hospital — Hollywood
- AdventHealth — Orlando
- Peyton Manning Children's Hospital — Indianapolis
- Norton Children's Hospital — Louisville
- Children's Mercy Hospital — Kansas City
- … and 9 more centers
Canada · 3 centers
- Sunnybrook Health Sciences Centre — Toronto
- Mt Sinai Hospital — Toronto
- BC Children's and Women's Hospital — Vancouver
Publications
- Matlock DN, Ratcliffe SJ, Courtney SE, Kirpalani H, Firestone K, Stein H, Dysart K, Warren K, Goldstein MR, Lund KC, Natarajan A, Demissie E, Foglia EE. The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial: study protocol for a randomized controlled trial comparing rates of extubation failure in extremely premature infants undergoing extubation to non-invasive neurally adjusted ventilatory PMID 38509583
Identifiers
NCT: NCT05446272 · 849912