Funding: NHLBI
Investigator: Foglia, E
The DIVA Trial is a National Heart, Lung and Blood Institute funded multicenter randomized comparative effectiveness trial comparing 2 FDA-approved modes of respiratory support to prevent extubation failure among extremely preterm infants. The preterm (23-28 weeks gestation) babies will be randomly placed into either a non-invasive neurally adjusted ventilatory assist or non-synchronized nasal intermittent positive pressure ventilation treatment for bronchopulmonary dysplasia. Bronchopulmonary dysplasia is the most common complication for premature babies and is the leading respiratory cause of death.
The DIVA project launched in September 2021 led by Elizabeth Foglia, MD MSCE, at the Hospital of the University of Pennsylvania. The Clinical Research Collaboration Unit (CRCU) serves as the Data Coordinating Center for this study. Statistical operations are centered at the University of Virginia while data management, project management including regulatory oversight across sites and research technology support are conducted at the University of Pennsylvania under the guidance of Jesse Hsu, PhD.
The trial plans to enroll 478 infants into the study at the following 16 sites across the United States and Canada: University of Pennsylvania, Arkansas Children’s Hospital, University of Arkansas Medical Sciences, Children’s Hospital of Richmond, Intermountain Medical Center, Utah Valley Hospital, Norton Children’s Hospital, Mt Sinai Hospital, Loma Linda Hospital, Nationwide Children’s Hospital, St. Louis Children’s Hospital, Virtua Vorhees Hospital, Children’s Mercy Hospital, Sharp Mary Birch Hospital, Joe Di Maggio Children’s and BC Children’s and Women’s Hospital.