The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

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.

Conditions

Extubation Failure, Bronchopulmonary Dysplasia, Death

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

Condition
Extubation Failure
Intervention / Treatment

-

Contacts and Locations

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202

Loma Linda

Loma Linda University, Loma Linda, California, United States, 92350

San Diego

Sharp Mary Birch, San Diego, California, United States, 92123

Hollywood

Joe DiMaggio Children's Hospital, Hollywood, Florida, United States, 33021

Orlando

AdventHealth, Orlando, Florida, United States, 32803

Indianapolis

Peyton Manning Children's Hospital, Indianapolis, Indiana, United States, 46260

Louisville

Norton Children's Hospital, Louisville, Kentucky, United States, 40202

Kansas City

Children's Mercy Hospital, Kansas City, Missouri, United States, 64108

Saint Louis

Washington University in St.Louis, Saint Louis, Missouri, United States, 63110

Voorhees

Virtua Vorhees Hospital, Voorhees, New Jersey, United States, 08043

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

0 Days to 9 Weeks

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

Elizabeth Foglia, PRINCIPAL_INVESTIGATOR, CHOP/UPENN

Study Record Dates

2027-03-31