NIV-NAVA vs NS-NIPPV for Extreme Premature Infants
The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
Recruiting
N/A
Interventional Study
Extubation Failure
Bronchopulmonary Dysplasia
Death
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 0 Days – 9 Weeks
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 478 (estimated)
- Sponsor
- University of Pennsylvania · Other
Who this trial is looking for
This trial is looking for preterm infants born between 23 and 28 weeks of gestation who need help with breathing. If you take part, you will receive either one of two types of breathing support after being on a ventilator.
Are You a Good Fit for This Trial?
You may be able to join if
- I was born between 23 and 28 weeks of gestation
- I was intubated in the first week of life
- I am being taken off a ventilator after at least 12 hours of mechanical ventilation
- I am less than 32 weeks old at the time of being taken off the ventilator
You may not be able to join if
- I have major birth defects, including problems with my lungs
- I have brain disorders affecting my ability to breathe (other than apnea of prematurity)
- I have had esophageal bleeding or cannot have a feeding tube placed
- I currently weigh less than 500 grams
- The ventilator needed for this trial is not available for me
- I have surgery or an invasive procedure planned within 5 days of being taken off the ventilator
- I or my guardians have not given permission to join the trial
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About 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 w…
Trial Locations
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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 co…
Contacts