The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
Recruiting now · Not applicable
Conditions studied: Extubation Failure, Bronchopulmonary Dysplasia, Death
In brief
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.
Key facts
- Study ID
- NCT05446272
- Run by
- University of Pennsylvania
- People needed
- 478
- Starts
- 2022-08-03
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-06-25
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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
Where it is running
- BC Children's and Women's Hospital — Vancouver, Canada (enrolling)
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (enrolling)
- Sharp Mary Birch — San Diego, California, United States (enrolling)
- Joe DiMaggio Children's Hospital — Hollywood, Florida, United States (enrolling)
- AdventHealth — Orlando, Florida, United States (enrolling)
- Peyton Manning Children's Hospital — Indianapolis, Indiana, United States (enrolling)
- Norton Children's Hospital — Louisville, Kentucky, United States (enrolling)
- Children's Mercy Hospital — Kansas City, Missouri, United States (enrolling)
- Washington University in St.Louis — St Louis, Missouri, United States (enrolling)
- Virtua Vorhees Hospital — Voorhees Township, New Jersey, United States (enrolling)
- Levine Children's Hospital — Charlotte, North Carolina, United States (enrolling)
- Atrial Health Brenner Children's Hospital( Wake Forest) — Winston-Salem, North Carolina, United States (enrolling)
- Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- Intermountain Medical Center — Murray, Utah, United States (enrolling)
- Utah Valley Hospital — Provo, Utah, United States (enrolling)
- Children's Hospital of Richmond — Richmond, Virginia, United States (enrolling)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (enrolling)
- Mt Sinai Hospital — Toronto, Canada (enrolling)
- Loma Linda University — Loma Linda, California, United States
Full record on ClinicalTrials.gov
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