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Comparing two non-invasive ventilation methods for preterm infants after extubation

The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

Not applicable Interventional University of Pennsylvania · NCT05446272

This study is testing whether a new breathing support method is better than a standard one for extremely preterm infants who are coming off a ventilator to see if it helps them avoid complications.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment478 (estimated)
Ages0 Days to 9 Weeks
SexAll
SponsorUniversity of Pennsylvania Academic / other
Locations20 sites (Little Rock, Arkansas and 19 other locations)
Trial IDNCT05446272 on ClinicalTrials.gov

What this trial studies

The DIVA trial is a pragmatic randomized clinical trial aimed at determining whether non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is more effective than non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV) in preventing extubation failure in extremely preterm infants. The study focuses on infants born between 23 0/7 and 28 6/7 weeks gestation who are undergoing extubation after mechanical ventilation. By comparing these two ventilation strategies, the trial seeks to reduce the incidence of complications associated with extubation failure, such as bronchopulmonary dysplasia. The trial is multicenter and unblinded, involving several hospitals across the United States.

Who should consider this trial

Good fit: Ideal candidates for this study are preterm infants born between 23 0/7 and 28 6/7 weeks gestation who are intubated and undergoing extubation after at least 12 hours of mechanical ventilation.

Not a fit: Patients with major congenital anomalies, significant neurologic disorders, or those weighing less than 500 grams may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the rates of extubation failure and associated complications in extremely preterm infants.

How similar studies have performed: Other studies have explored non-invasive ventilation strategies, but this specific comparison of NIV-NAVA and NS-NIPPV in this population is novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Little Rock, Arkansas and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Extubation FailureBronchopulmonary DysplasiaDeath
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.