A request for applications (RFA) is proposed entitled: Advanced Analytics for Rapid Point-of-Care Testing for Perinatal and Pediatric Critical Care, and Research.
This proposed RFA will use the STTR R41 mechanism. I also want to stress that along with the STTR, we will release a Program Announcement for Bioengineering Research Proposals (BRP) using R01 mechanism. We seek Council approval for the R41 concept.
This initiative is to stimulate basic and translational research to be undertaken by the bioengineering research community to develop advanced methods for the rapid measurement of biochemical products in human tissues and fluids that would aid in clinical care and research for newborn infants and children, and women during pregnancy and during lactation. We encourage development of non-invasive or minimally invasive methods using and/integrating the evolving science of Lab-on-a-Chip methodologies for developing specific analyte sensors.
In spite of major advances neonatal and pediatric intensive care still involves conducting painful needle-punctures to obtain blood samples for routine clinical monitoring to measure and monitor, serum electrolytes, and other biochemical products that assess metabolic, kidney, hepatic, and cardio-respiratory functions.
Similarly, research on drugs and medications in pregnant and lactating women and in high-risk newborn infants have been limited. As a consequence, over 80% of medications used in the NICU are not labelled for newborn use. Similar situation exists when one considers the use of drugs, medications and vaccines in during pregnancy and lactation.
One of the hurdles for developing strong evidence base in this field is the lack of simple, non-or-minimally invasive methodologies for measuring and monitoring biochemical variables during pharmacological research. The requirement for obtaining blood samples and other biological specimen repeatedly leads to difficulty in obtaining IRB approvals, and adds to the complexity of conducting research in pregnant and lactating women, and in sick infants and children.
Thus, development of common platforms may help solve clinical and research needs in the perinatal, neonatal and pediatric populations. This initiative is therefore is being proposed to stimulate the bioengineering scientists to develop micro-chip based methodologies and platforms that would facilitate both research and clinical care in this critical area of perinatal and neonatal medicine.
This FOA will stimulate bioengineering research community to develop simple platforms for measuring and monitoring biochemical variables from biological materials to help in clinical monitoring and research.
The proposal will require developing micro-chip approaches for rapid, POC testing of analytes, including, but not limited to: Serum electrolytes; liver function tests (e.g., liver enzymes, bilirubin); renal functions (e.g., BUN, creatinine; serum electrolytes); biomarkers of infection and inflammation; metabolic by-products of drugs; concentrations of drugs used in clinical care or research.
Platforms that can utilize materials obtained from a variety of sources: trans-epidermal, or sensor techniques to monitor biochemical products in real-time, and those enabling the use of hair, tears, urine, salivary and nasal secretions.
Tonse N. K. Raju, MD
Pregnancy and Perinatology Branch
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