# 1/2 The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

> **NIH NIH UG3** · UNIVERSITY OF PENNSYLVANIA · 2021 · $416,018

## Abstract

PROJECT SUMMARY
 Bronchopulmonary dysplasia (BPD) is the most common complication of prematurity and is the leading
respiratory cause of childhood morbidity. BPD results in a significant burden to families and increased health
care utilization. In the United States alone BPD accounts for over $2.4 billion in healthcare costs annually.
 Ventilator induced lung injury (VILI) 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. Because even brief exposure to positive pressure ventilation is injurious, avoiding invasive
intubated mechanical ventilation is the most widely acknowledged strategy to prevent VILI and the long-term
sequela of BPD. Therefore, time on ventilators and rates of successful extubation are important endpoints of
therapy.
 Lung protective strategies prioritize non-invasive respiratory support for preterm infants with respiratory
failure, but failure rates of continuous positive airway pressure (CPAP) therapy are high. In meta-analysis of
available trials, both synchronized and non-synchronized non-invasive positive pressure ventilation (NIPPV)
are superior to CPAP for preventing extubation failure in preterm infants. A stronger effect size was observed
for synchronized NIPPV vs. CPAP than for non-synchronized NIPPV vs. CPAP. However, until recently no
FDA-approved reliable methods to provide synchronized NIPPV for preterm infants were available in the US
 Neurally Adjusted Ventilatory Assist (NAVA), an FDA approved technology, is a novel method to
synchronize ventilatory support 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. To date, the clinical impact of non-invasive NAVA (NIV-NAVA) on clinical outcomes in
preterm infants has not been established. In these clustered UG3/UH3 and U24 applications, we propose a
pragmatic, unblinded, phase III clinical trial in 478 extremely preterm infants of 24 0/7- 27 6/7 weeks gestational
age to determine if NIV-NAVA, compared with non-synchronized NIPPV, prevents extubation failure within 5
days of extubation from mechanical ventilation.

## Key facts

- **NIH application ID:** 10214861
- **Project number:** 1UG3HL152305-01A1
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** Sherry Courtney
- **Activity code:** UG3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $416,018
- **Award type:** 1
- **Project period:** 2021-09-17 → 2022-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10214861

## Citation

> US National Institutes of Health, RePORTER application 10214861, 1/2 The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial (1UG3HL152305-01A1). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10214861. Licensed CC0.

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