Ventilatory Support Methods for Extubation Failure in Preterm Infants
(DIVA Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
What data supports the effectiveness of the treatment NIV-NAVA for extubation failure in preterm infants?
Is non-invasive neurally adjusted ventilatory assist (NIV-NAVA) safe for use in preterm infants?
Research on non-invasive neurally adjusted ventilatory assist (NIV-NAVA) in preterm infants suggests it is generally safe, with studies focusing on its effectiveness and adverse effects. While the evidence is less robust compared to invasive methods, no significant safety concerns have been highlighted in the studies available.12345
How is the treatment NIV-NAVA different from other treatments for extubation failure in preterm infants?
NIV-NAVA is unique because it uses the electrical activity of the diaphragm (the main muscle used for breathing) to synchronize the ventilator's support with the infant's natural breathing efforts, potentially improving breathing support and reducing the need for reintubation compared to other methods like NCPAP.12346
Research Team
Elizabeth Foglia
Principal Investigator
CHOP/UPENN
Eligibility Criteria
The DIVA trial is for preterm infants born between 24 and 27 weeks who were intubated within their first week of life. They must be less than 28 days old when extubated after at least 12 hours on a ventilator. Infants under 500 grams, without consent, needing surgery soon, or with certain health issues can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either NIV-NAVA or NS-NIPPV to prevent extubation failure
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Monitoring for prematurity-related morbidities and other outcomes
Treatment Details
Interventions
- NIV-NAVA
- NS-NIPPV
NIV-NAVA is already approved in United States, Canada for the following indications:
- Prevention of extubation failure in preterm infants
- Prevention of extubation failure in preterm infants
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator