Optimization of saturation targets and resuscitation trial (optistart)

Active Project Grant Awarded Last action

Award ID
R01HD104970
Recipient
Awarding agency
Obligated
$5,128,343

Award facts

Completion date 86% complete
Place of performance
Dallas, TX 75390, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
This study is designed to answer one of the fundamental gaps in knowledge in the resuscitation of preterm infants at birth: what is the optimal target oxygen saturation (SPO2) range that increases survival without long- term morbidities? Oxygen (O2) is routinely used for the stabilization of preterm infants in the delivery room (DR), but its use is linked with mortality and several morbidities including bronchopulmonary dysplasia (BPD). To balance the need to give sufficient O2 to correct hypoxia and avoid excess O2, the neonatal resuscitation program (NRP) recommends initiating preterm resuscitation with low (= 30%) inspired O2 concentration (FIO2) and subsequent titration to achieve a specified target SPO2 range. These SPO2 targets are based on approximated 50TH percentile SPO2 (SAT50) observed in healthy term infants. However, the optimal SPO2 targets remain undefined in the preterm infants. Recent data suggest that the inability to achieve SPO2 of 80% by five minutes is associated with intraventricular hemorrhage (IVH) and mortality. These studies raise concern that current SPO2 targets (SAT50) may be too low resulting in persistence of high pulmonary vascular resistance, respiratory failure and mortality. Preliminary data from my nichd K23 funded pilot randomized controlled trial (RCT) of 75 preterm infants

Transactions

Action Obligated Date
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Amendment $507,397
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Amendment $494,209
Original award $494,209
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Subawards

Subrecipient Amount Awarded
University Of Florida Screen and enroll neonates 23 0/7 – 30 6/7 weeks GA to Sat75 (intervention) or Sat50 (control), collect relevant maternal medical, pregnancy and birth… $7,200
University Of Alabama At Birmingham UAB will implement the necessary regulatory approvals, including IRB. His study coordinators will screen OB unit census daily to identify eligible mothers for… $403,357
Sharp Mary Birch Hospital For Women And Newborns Site PI will be responsible for patient enrollment, data collection and verification, assuring that all the patient data is consistently, safely and securely… $48,839
Baylor College Of Medicine Optimization of Saturation Targets And Resuscitation Trial (OptiSTART) $50,500
University Of Utah Optimization of Saturation Targets and Resuscitation Trial (OptiSTART) $38,471
PMG Services Inc. Implement the necessary regulatory approvals, including IRB. The study coordinators will screen the OB unit census daily to identify eligible mothers for the… $95,650
University Of Oklahoma Dr. Shah, as Site PI, will implement the necessary regulatory approvals, including IRB, CRIOC and reliance agreement. His study coordinators will screen OB unit… $142,909
University Of Pittsburgh - Of The Commonwealth System Of Higher Education Dr. Randall, Alice as the Site PI, will provide neonatology expertise in study design, data acquisition, data analysis and interpretation, presentation and… $52,959

Quick answers

Who received award R01HD104970?

R01HD104970 was awarded to The University Of Texas Southwestern Medical Center by National Institute of Child Health and Human Development (National Institutes of Health) on July 21, 2022.

How much is award R01HD104970 worth?

$5,128,343 has been obligated on R01HD104970.

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