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

> **NIH NIH U24** · UNIVERSITY OF VIRGINIA · 2024 · $401,869

## Abstract

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.

## Key facts

- **NIH application ID:** 10745976
- **Project number:** 5U24HL152304-03
- **Recipient organization:** UNIVERSITY OF VIRGINIA
- **Principal Investigator:** Sarah J Ratcliffe
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $401,869
- **Award type:** 5
- **Project period:** 2021-09-03 → 2026-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10745976

## Citation

> US National Institutes of Health, RePORTER application 10745976, 2/2 The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial (5U24HL152304-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10745976. Licensed CC0.

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