A request for applications (RFA) with set aside is proposed, entitled “Tools for Assessment and Improvement of Neurologic Outcomes” using the R43 Small Business Innovation Research (SBIR) Grant - Phase I only and the R41 Small Business Technology Transfer (STTR) Grant - Phase I only grant mechanisms.
Improving pregnancy outcome is a prime mission for NICHD. Neonatal neurologic disease contributes a significant burden to patients, their families and society. Neonatal encephalopathy (NE) affects up to 3.3/1000 term and late preterm infants in the developed world. Hypoxic ischemic encephalopathy (HIE), a subset of neonatal encephalopathy, affects 1-2/1000 infants per year. Cerebral palsy (CP) is one of the outcomes associated with NE and HIE, and approximately 30% of term and late preterm CP will have neonatal encephalopathy. The prevalence of CP is 2/1000 live births and approximately two thirds are born at term or late preterm. Premature infants, infants with metabolic disease, and sequelae of complications in the neonatal period can lead to significant neurologic morbidity. Technologies to assess pregnancies at risk for infants with deleterious neurologic outcomes as well as tools to treat such infants are desperately needed to improve outcomes.
Responsive applications can include studies to develop tools to identify high risk and at risk pregnancies and infants. Biomarker identification, novel neuroprotective agents and strategies as well as interventions for neurologic disorders would be deemed responsive to this initiative. Neuroprotection including neuroprotective resuscitation tools and techniques, novel methods of monitoring and delivering hypothermic neural rescue particularly in the transport setting, and novel therapies to improve neurologic function in infants with neurologic disease, especially for infants at high risk for cerebral palsy are considered within the scope of this program.
The objective of this concept is to foster development of tools and technology for diagnosis, intervention and improvement of outcomes for pregnancies as well as infants with known neurologic disease or infants at high risk for neurologic complications.
Rosemary D. Higgins, MD
Pregnancy and Perinatology Branch
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