Recruiting

DIVA

Sponsor:

University of Pennsylvania

Code:

NCT05446272

Conditions

Extubation Failure

Bronchopulmonary Dysplasia

Death

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

NIV-NAVA

NS-NIPPV

Study Details

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.

Conditions

Extubation Failure

Bronchopulmonary Dysplasia

Death

Study ID

NCT05446272

Start date

Aug 3, 2022

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

478 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NIV-NAVA

active comparator: NS- NIPPV

Interventions

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.

Primary outcome measure

  • Extubation failure [ Time Frame: within the first 5 days (120 hours) post extubation ]

Central Contacts and Locations

Central contacts

Elizabeth Foglia

267-441-7144FOGLIA@email.chop.edu

Lisa Wesby, MS

215-573-6318wesby@pennmedicine.upenn.edu

Locations

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

David Matlock

DMatlock@uams.edu

Sharp Mary Birch

Recruiting

San Diego, California, United States, 92123

Contacts

Anup Katheria

Anup.Katheria@sharp.com

Joe DiMaggio Children's Hospital

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Bruce Shulman

brucesmd@icloud.com

AdventHealth

Recruiting

Orlando, Florida, United States, 32803

Contacts

Samarth Shukla

Samarth.Shukla.MD@AdventHealth.com

Peyton Manning Children's Hospital

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Markus Tauscher

mktausc1@ascension.org

Norton Children's Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Dan Stewart

dan.stewart@louisville.edu

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Christopher Nitkin

crnitkin@cmh.edu

Washington University in St.Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

rao_r@wustl.edu

Virtua Vorhees Hospital

Recruiting

Voorhees Township, New Jersey, United States, 08043

Contacts

ghavams@chop.edu

Levine Children's Hospital

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Eugenia Pallotto

Eugenia.Pallotto@atriumhealth.org

Atrial Health Brenner Children's Hospital( Wake Forest)

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Ricardo J Rodriguez

rjrodrig@wakehealth.edu

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Matthew.Kielt@nationwidechildrens.org

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Elizabeth Foglia

FOGLIA@email.chop.edu

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Bradley Yoder

Bradley.Yoder@hsc.utah.edu

Utah Valley Hospital

Recruiting

Provo, Utah, United States, 84604

Contacts

Bradley.Yoder@hsc.utah.edu

Children's Hospital of Richmond

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Karen Hendrick-Munoz

karen.hendricks-munoz@vcuhealth.org

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Maher Shahroor

maher.shahroor@sunnybrook.ca

Mt Sinai Hospital

Recruiting

Toronto, Canada, ON M5G 1X5

Contacts

Amish Jain

Amish.Jain@sinaihealth.ca

BC Children's and Women's Hospital

Recruiting

Vancouver, Canada, BC V6H 3N1

Contacts

Jonathan Wong

jonathan.wong@cw.bc.ca

More Information

Sponsor

University of Pennsylvania

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-06-25.