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

Award Number: U24HL152304
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/03/2021
PERIOD OF PERFORMANCE END DATE: 11/30/2026

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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, but failure rates of non-invasive respiratory support (ie: continuous positive airway pressure [CPAP]) are high. In 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 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $555,047 )
2026	2026	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Lung Diseases Research	000	5	5/12/2026	NON-COMPETING CONTINUATION	$555,047
														Subtotal = $555,047

Issue Date FY: 2025 ( Subtotal = $443,071 )
2025	2025	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Lung Diseases Research	002	4	8/1/2025	NON-COMPETING CONTINUATION	$41,027
2025	2025	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Lung Diseases Research	000	4	12/12/2024	NON-COMPETING CONTINUATION	$369,238
2025	2024	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Lung Diseases Research	001	3	1/15/2025	NON-COMPETING CONTINUATION	$32,806
														Subtotal = $443,071

Issue Date FY: 2024 ( Subtotal = $369,063 )
2024	2024	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Lung Diseases Research	000	3	12/15/2023	NON-COMPETING CONTINUATION	$369,063
														Subtotal = $369,063

Issue Date FY: 2023 ( Subtotal = $426,255 )
2023	2023	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Lung Diseases Research	001	2	11/25/2022	NON-COMPETING CONTINUATION	$426,255
2023	2021	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Lung Diseases Research	000	1	11/23/2022	NEW	$0
														Subtotal = $426,255

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Lung Diseases Research	000	1	8/2/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $544,353 )
2021	2021	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Lung Diseases Research	000	1	9/2/2021	NEW	$544,353
														Subtotal = $544,353

Grand Total All Awards = $2,337,789

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

Award Number: U24HL152304

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/03/2021

PERIOD OF PERFORMANCE END DATE: 11/30/2026

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