1/2 the diaphragmatic initiated ventilatory assist (DIVA) trial

Ended Cooperative Agreement Awarded Last action

Award ID
UG3HL152305
Recipient
Awarding agency
Obligated
$317,825

Award facts

Assistance listing
93.837 Cardiovascular Diseases Research
Completion date
Originally
Place of performance
Philadelphia, PA 19104, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
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.

Transactions

Action Obligated Date
Amendment -$98,193
Amendment $0
Amendment $0
Amendment $0
Amendment $0
Original award $416,018

Subawards

Subrecipient Amount Awarded
The Children's Hospital Of Philadelphia "Dr. Eichenwald and Karen Warren will be responsible for overseeing the eligibility, recruitment, enrollment, consent, and data collection for all… $60,000
Wake Forest University Health Sciences Capitated costs are allocated to compensate each site for patient enrollment ($1,500/patient inclusive of indirects). Subrecipient may enroll up to 36… $36,000
PMG Services Inc. "Sites will be responsible to screen for eligible patients to be enrolled as per Research Strategy. Once infants have been identified the study coordinator will… $30,500
The Washington University Sites will be responsible to screen for eligible patients to be enrolled as per Research Strategy. Once infants have been identified the study coordinator… $32,640
The Children's Hospital Of Philadelphia "Dr. Eichenwald and Karen Warren will be responsible for overseeing the eligibility, recruitment, enrollment, consent, and data collection for all… $210,230
Adventist Health System / Sunbelt Inc. Capitated costs are allocated to compensate each site for patient enrollment ($1,500/patient inclusive of indirects). Subrecipient may enroll up to 3 patients… $32,000
Sinai Health System Sites will be responsible to screen for eligible patients to be enrolled as per Research Strategy. Once infants have been identified the study coordinator… $30,500
Sharp Healthcare $23,145
University Of Utah $30,000
Childrens Mercy Hospital $17,160
Arkansas Children's Research Institute See attached $95,781
Research Institute At Nationwide Children's Hospital Sites will be responsible to screen for eligible patients to be enrolled as per Research Strategy. Once infants have been identified the study coordinator… $32,000
The Washington University $32,640
The Children's Hospital Of Philadelphia Dr. Eichenwald and Karen Warren will be responsible for overseeing the eligibility, recruitment, enrollment, consent, and data collection for all participants… $142,683
Adventist Health System / Sunbelt Inc. Capitated costs are allocated to compensate each site for patient enrollment ($1,500/patient inclusive of indirects). Subrecipient may enroll up to 3 patients… $6,500
Wake Forest University Health Sciences Capitated costs are allocated to compensate each site for patient enrollment ($1,500/patient inclusive of indirects). Subrecipient may enroll up to 36… $56,000
The Children's Hospital Of Philadelphia Dr. Eichenwald and Karen Warren will be responsible for overseeing the eligibility, recruitment, enrollment, consent, and data collection for all participants… $108,374
Sinai Health System Sites will be responsible to screen for eligible patients to be enrolled as per Research Strategy. Once infants have been identified the study coordinator… $24,500
PMG Services Inc. $24,500
University Of Louisville (See Attached) $24,500
Virginia Commonwealth University Sites will be responsible to screen for eligible patients to be enrolled as per Research Strategy. Once infants have been identified the study coordinator… $24,000
Arkansas Children's Research Institute See attached $80,781
Sharp Mary Birch Hospital For Women And Newborns Sites will be responsible to screen for eligible patients to be enrolled as per Research Strategy. Once infants have been identified the study coordinator… $24,500
Ascension Health (See Attached) $24,500
Show all 24

Quick answers

Who received award UG3HL152305?

UG3HL152305 was awarded to The Trustees Of The University Of Pennsylvania by National Heart Lung and Blood Institute (National Institutes of Health) on September 17, 2021.

How much is award UG3HL152305 worth?

$317,825 has been obligated on UG3HL152305.

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