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The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

RecruitingNAAges 0 Days - 9 WeeksAllUniversity of Pennsylvania
NCT05446272 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • NIV-NAVA
  • NS-NIPPV
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Where

20 sites
Arkansas Children's Hospital
Little Rock, United States
Loma Linda University
Loma Linda, United States
Sharp Mary Birch
San Diego, United States
Joe DiMaggio Children's Hospital
Hollywood, United States
AdventHealth
Orlando, United States
Peyton Manning Children's Hospital
Indianapolis, United States
Norton Children's Hospital
Louisville, United States
Children's Mercy Hospital
Kansas City, United States

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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