The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
DIVA
1 other identifier
interventional
478
2 countries
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2022
CompletedFirst Posted
Study publicly available on registry
July 6, 2022
CompletedStudy Start
First participant enrolled
August 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
ExpectedOctober 7, 2025
October 1, 2025
3.7 years
June 28, 2022
October 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Extubation failure
Extubation failure is defined when an infant is on the allocated mode of respiratory support and meets any of the following 4 criteria: (1) Rise in FiO2 at least 20% from pre-extubation value for \>2 hours to maintain local SpO2 targets, (2) pH ≤7.20 or pCO2 ≥70mm Hg; (3) \>1 apneic event requiring positive pressure ventilation (PPV) within 6 hours or ≥ 6 apneic events requiring stimulation within 6 hours (4) emergent intubation by the clinical team for cardiovascular instability or surgery.
within the first 5 days (120 hours) post extubation
Secondary Outcomes (7)
Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA
36 weeks PMA
Death or BPD at 36 weeks PMA
36 weeks PMA
Endotracheal intubation through 36 weeks PMA
36 weeks PMA
Postmenstrual age at last invasive ventilation
36 weeks PMA
Postmenstrual age at last positive pressure support
36 weeks PMA
- +2 more secondary outcomes
Other Outcomes (8)
Death
From randomization through 36 weeks PMA
Air Leaks
From randomization through 36 weeks PMA
Gastrointestinal perforation or bleeding
From randomization through 36 weeks PMA
- +5 more other outcomes
Study Arms (2)
NIV-NAVA
EXPERIMENTALNS- NIPPV
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Loma Linda University
Loma Linda, California, 92350, United States
Sharp Mary Birch
San Diego, California, 92123, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
AdventHealth
Orlando, Florida, 32803, United States
Peyton Manning Children's Hospital
Indianapolis, Indiana, 46260, United States
Norton Children's Hospital
Louisville, Kentucky, 40202, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University in St.Louis
St Louis, Missouri, 63110, United States
Virtua Vorhees Hospital
Voorhees Township, New Jersey, 08043, United States
Levine Children's Hospital
Charlotte, North Carolina, 28203, United States
Atrial Health Brenner Children's Hospital( Wake Forest)
Winston-Salem, North Carolina, 27157, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Utah Valley Hospital
Provo, Utah, 84604, United States
Children's Hospital of Richmond
Richmond, Virginia, 23219, United States
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5, Canada
Mt Sinai Hospital
Toronto, ON M5G 1X5, Canada
BC Children's and Women's Hospital
Vancouver, BC V6H 3N1, Canada
Related Publications (1)
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.
PMID: 38509583DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Foglia
CHOP/UPENN
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Trial PIs are unaware of treatment allocation for individual subjects
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2022
First Posted
July 6, 2022
Study Start
August 3, 2022
Primary Completion
March 31, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
October 7, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 3 years after completion of the study
Research records will be retained at each study site, and at the DCC for 3 years after completion of the study. We will follow NIH sharing policies with regards to sharing of data and specimens to public repositories, where appropriate