U24HL152304

2/2 The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial - Summary

Chronic lung disease and complications from preterm birth are the leading pediatric contributors to years of life lost in the USA. Bronchopulmonary dysplasia (BPD), a chronic lung disease, is the most common sequela of prematurity and is the leading respiratory cause of childhood morbidity. In the United States alone, BPD accounts for over $2.4 billion in healthcare costs annually.

Ventilator-induced lung injury (VILI) is an accepted and important contributor to BPD. Exposure to oxygen and positive pressure ventilation leads to developmental arrest and parenchymal injury in the immature preterm lung. Lung protective strategies, therefore, prioritize non-invasive respiratory support for preterm infants with respiratory failure. However, failure rates of non-invasive respiratory support (e.g., continuous positive airway pressure [CPAP]) are high.

In a meta-analysis of trials of nasal non-invasive intermittent positive pressure ventilation (NIPPV), synchronized NIPPV significantly reduced the incidence of BPD when compared with CPAP. This benefit was not seen with non-synchronized NIPPV. However, current standard means of synchronization are unreliable and do not deliver consistent synchronization.

Neurally adjusted ventilatory assist (NAVA), an FDA-approved technology, is a novel method to synchronize non-invasive support (NIV) with infant respiratory drive. This effective non-invasive synchronization matches electrical diaphragmatic activity to deliver synchronized and accurate tidal volumes in proportion to the neural signal.

In these clustered UG3/UH3 and U24 applications, we propose a pragmatic, unblinded, phase III, randomized controlled trial (RCT) in 358 preterm infants 240/7-276/7 weeks gestation in respiratory failure. The aim of this trial is to determine if NIV-NAVA, compared with non-synchronized nasal intermittent positive pressure ventilation (NIPPV), will reduce the incidence of extubation failure within 5 days of extubation from mechanical ventilation.

Rector & Visitors Of The University Of Virginia

THE DIVISION OF LUNG DISEASES SUPPORTS RESEARCH AND RESEARCH TRAINING ON THE CAUSES, DIAGNOSIS, PREVENTION, AND TREATMENT OF LUNG DISEASES AND SLEEP DISORDERS. RESEARCH IS FUNDED THROUGH INVESTIGATOR-INITIATED AND INSTITUTE-INITIATED GRANT PROGRAMS AND THROUGH CONTRACT PROGRAMS IN AREAS INCLUDING ASTHMA, BRONCHOPULMONARY DYSPLASIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CYSTIC FIBROSIS, RESPIRATORY NEUROBIOLOGY, SLEEP AND CIRCADIAN BIOLOGY, SLEEP-DISORDERED BREATHING, CRITICAL CARE AND ACUTE LUNG INJURY, DEVELOPMENTAL BIOLOGY AND PEDIATRIC PULMONARY DISEASES, IMMUNOLOGIC AND FIBROTIC PULMONARY DISEASE, RARE LUNG DISORDERS, PULMONARY VASCULAR DISEASE, AND PULMONARY COMPLICATIONS OF AIDS AND TUBERCULOSIS. THE DIVISION IS RESPONSIBLE FOR MONITORING THE LATEST RESEARCH DEVELOPMENTS IN THE EXTRAMURAL SCIENTIFIC COMMUNITY AS WELL AS IDENTIFYING RESEARCH GAPS AND NEEDS, OBTAINING ADVICE FROM EXPERTS IN THE FIELD, AND IMPLEMENTING PROGRAMS TO ADDRESS NEW OPPORTUNITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.

93.837 - Cardiovascular Diseases Research

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

Virginia United States

State-Wide

Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required) (PAR-19-330)

Amendment Since initial award the End Date has been extended from 07/31/26 to 11/30/26 and the total obligations have increased 227% from $544,353 to $1,782,742.