NCT05446272 · University of Pennsylvania
The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
(DIVA)
What this study is about
DIVA is a pragmatic randomly assigned 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Little Rock, Arkansas
- Loma Linda, California
- San Diego, California
- Hollywood, Florida
- Orlando, Florida
- Indianapolis, Indiana
- Louisville, Kentucky
- Kansas City, Missouri
- St Louis, Missouri
- Voorhees Township, New Jersey
- Charlotte, North Carolina
- Winston-Salem, North Carolina
And 5 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations