The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
NCT ID: NCT05446272
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
478 participants
INTERVENTIONAL
2022-08-03
2027-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Does NIV-NAVA Improve Diaphragmatic Function in Preterm Infants
NCT05079412
Noninvasive NAVA Versus NIPPV in Low Birthweight Premature Infants
NCT03137225
Work of Breathing During Non-invasive Ventilation in Premature Neonates
NCT02788110
Comparison of NIV-NAVA vs. N-CPAP After Extubation in Preterm Infants Study
NCT02590757
Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
NCT01440647
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is an FDA approved technology that consistently synchronizes non-invasive respiratory support with infant respiratory drive. The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial is an unblinded, pragmatic, multicenter phase III randomized clinical trial in extremely preterm infants 23 0/7- 28 6/7 weeks gestational age to determine if NIV-NAVA, compared with non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV), prevents extubation failure within 5 days (120 hours) of extubation from mechanical ventilation
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NIV-NAVA
NIV-NAVA
Infants in the intervention arm will be managed with non-invasive neurally adjusted ventilatory assist (NIV-NAVA) using FDA-approved servos with associated FDA-approved Edi catheter.
NS- NIPPV
NS-NIPPV
Infants in the active comparator arm will be treated with non-synchronized non-invasive positive pressure ventilation (NIPPV) through FDA-approved ventilators currently in use at each site.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NIV-NAVA
Infants in the intervention arm will be managed with non-invasive neurally adjusted ventilatory assist (NIV-NAVA) using FDA-approved servos with associated FDA-approved Edi catheter.
NS-NIPPV
Infants in the active comparator arm will be treated with non-synchronized non-invasive positive pressure ventilation (NIPPV) through FDA-approved ventilators currently in use at each site.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
0 Days
9 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Pennsylvania
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elizabeth Foglia
Role: PRINCIPAL_INVESTIGATOR
CHOP/UPENN
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Loma Linda University
Loma Linda, California, United States
Sharp Mary Birch
San Diego, California, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
AdventHealth
Orlando, Florida, United States
Peyton Manning Children's Hospital
Indianapolis, Indiana, United States
Norton Children's Hospital
Louisville, Kentucky, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Washington University in St.Louis
St Louis, Missouri, United States
Virtua Vorhees Hospital
Voorhees Township, New Jersey, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
Atrial Health Brenner Children's Hospital( Wake Forest)
Winston-Salem, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Intermountain Medical Center
Murray, Utah, United States
Utah Valley Hospital
Provo, Utah, United States
Children's Hospital of Richmond
Richmond, Virginia, United States
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Mt Sinai Hospital
Toronto, , Canada
BC Children's and Women's Hospital
Vancouver, , Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Roa Rakesh
Role: primary
Role: backup
Sarvin Ghavam
Role: primary
Role: backup
Matthew Kielt
Role: primary
Role: backup
Bradley Yoder
Role: primary
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Matlock DN, Ratcliffe SJ, Courtney SE, Kirpalani H, Firestone K, Stein H, Dysart K, Warren K, Goldstein MR, Lund KC, Natarajan A, Demissie E, Foglia EE. The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial: study protocol for a randomized controlled trial comparing rates of extubation failure in extremely premature infants undergoing extubation to non-invasive neurally adjusted ventilatory assist versus non-synchronized nasal intermittent positive pressure ventilation. Trials. 2024 Mar 20;25(1):201. doi: 10.1186/s13063-024-08038-4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
849912
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.