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Safe and Effective Instruments and Devices for Use in Neonatal and Pediatric Care Settings (R43/R44)

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Agency: Department of Health and Human Services
Program/Year: SBIR / 2013
Solicitation Number: PAR-13-090
Release Date: January 23, 2013
Open Date: March 5, 2013
Close Date: May 6, 2016 (closing in 563 days)
001: Funding Opportunity Description
Description:
Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) to propose research to develop new devices and instruments, and/or improve existing devices and instruments, to monitor and treat newborn infants and small children safely and efficaciously. 

Background

There are many unmet needs concerning device development in neonatal and pediatric care. A workshop held in May 2012 at NICHD highlighted the need for continued support. Devices and instruments developed for use in infants and children should be based on sound bioengineering principles. They also need to be tested for safety, efficacy, and accuracy of functioning. Despite major advances in biotechnology, research and development (R&D) efforts directed at introducing new and innovative pediatric devices and instruments (or improving the existing ones) for use in newborn infants and small children have been limited. 

Objectives

One objective of this FOA is to foster collaboration between clinical and bioengineering research communities in the field of pediatric device development. It is anticipated that through rigorous collaborative R&D efforts, safe and effective instruments and devices can be developed for use in newborn infants and children of all ages.  This FOA invites SBCs to propose innovative research that can lead to development of non-invasive, or minimally invasive, instruments, devices, and monitors that improve assessment, monitoring, and treatment of neonates, infants, and children of all ages who require routine as well as intensive care treatments.  In addition, this FOA aims to stimulate improvement in existing devices and instruments being used in pediatric care.  There is an urgent need for R&D in improving existing devices and instruments and introducing new devices and instruments while optimizing their utility and safety in the neonatal and pediatric intensive care, and out-patient settings.  The new and improved instruments and devices developed as a result will reduce the burden of morbidity and mortality associated with such devices, as well as providing a means for the clinical community to monitor key physiological and pathological processes while treating complex disorders in children.

Scope/Work to be Performed

The proposed studies need to establish the accuracy and safety of the device under varied clinical conditions. Studies may range from concept to developmental phases, with the goal of developing accurate devices that can be marketed, and used in regular clinical settings in newborn infants and pediatric patients of all ages. The major topic areas for the R&D efforts to be supported under this FOA include, but are not limited to: 

Cardiovascular:  Non-invasive or minimally invasive devices, instruments, or methods for assessing and supporting a variety of cardiovascular functions, including improved methods for measuring and monitoring systemic blood pressure such as advanced mathematical computations for analyzing cardiac pulse wave forms; devices to measure and monitor cardiac output and global tissue oxygen delivery;  improved methods of assessing blood volume and tissue perfusion; devices for use in cardiac surgery; interventional catheterization; and electrophysiology technologies for neonates and children.

Pulmonary:  Improved or non-invasive devices and instruments to measure pulmonary function (e.g., pulmonary arterial pressures, gas exchange, airway pressure,  lung volume, ventilation/perfusion ratios, PCO2 and PO2); improved systems for respiratory support with reduced air-leaks; non-invasive ventilation;  interfaces for nasal continuous positive airway pressure (CPAP) that do not affect musculoskeletal development; synchronized ventilation; improved methods of patient-triggered ventilation and pulmonary perfusion; automated inspired oxygen control; airway secretion clearance devices (including but not limited to applications for cystic  fibrosis children); improved aerosol delivery systems targeting small airways for use in newborn infants and small children on and off of ventilatory support; improved oxygen cannula tubing for infants during transportation; and diaphragm pacers for use in rapidly growing infants, children and pediatric patients.

Hematologic:  Non-invasive or minimally invasive methods: for testing hemostasis that provide results in a timely manner using small quantities of blood; for evaluating global hemostasis in very small infants, and in those requiring extra-corporeal membrane oxygenation (ECMO);  for monitoring the efficiency of either continuous or discontinuous dialysis treatments (e.g., for optimizing management of retained fluids);  and improved age and size-specific blood pumps to deliver small volumes of blood products.

Neurological:  Non-invasive or minimally invasive devices, instruments, and methods for assessing a variety of cerebrovascular functions, including methods for assessing global and regional cerebral blood and cerebrospinal flow, oxygen extraction, utilization of nutritional substrates, and autoregulation of cerebral blood flow; non-invasive or minimally invasive devices, instruments, and methods for evaluating central nervous system and peripheral nervous system function; neonatal seizure detection systems; devices and technologies to objectively assess pain in neonates, infants and children, and to evaluate the adequacy of analgesic therapies; devices for measuring the wavelengths and irradiance from commercial neonatal phototherapy units; devices and technologies to measure free components of indirect-bilirubin concentrations in the serum, to enable more accurate prediction of neurological injury from severe neonatal hyperbilirubinemia;  and optical imaging of the developing brain for assessing cerebrovascular structural and functional status.

Projects to conduct Phase I and Phase II clinical trials that fall under the mission of NINDS are not included in this FOA and should submit to PAR-12-072. NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions.

Metabolic:  Devices, instruments, and methods for assessing a variety of metabolic substrates, including sensors for non-invasive or minimally invasive measurement of blood metabolic chemicals, such as glucose, ketone bodies, and lactate/pyruvate, that are sensitive at the low plasma concentrations seen in the neonatal period;  micro-infusion pumps to optimize insulin administration and glucose control in neonates, infants, and small children;  technologies to monitor kidney function or injury, or to improve indwelling urinary or dialysis catheters used in neonates, infants, children; and sensors for the assessment of other blood chemical parameters (e.g., serum sodium, potassium, and chloride) in pediatric patients of all ages.

Kidney/Genitourinary:   Non-invasive, or minimally invasive approaches to develop devices, instruments, chemical molecules, and biomarkers to help study the mechanisms of normal and abnormal development of the kidney and genitourinary systems; to make early diagnosis of malformations, infections, and other renal-genitourinary disorders, and to prevent or treat renal and genitourinary diseases in fetal/neonatal and other pediatric patients.

Infections:  Devices, instruments, and methods for preventing, assessing and treating neonatal/pediatric infections, including innovative technologies for improving the quality of invasive catheters and tubes used during the evaluation and care of critically ill newborn infants, small children, and pediatric patients in ICU setting.  The catheters and their component systems may include IV tubes, indwelling catheters (venous, arterial, umbilical, percutaneous), connector-hubs, and syringes, and may include novel materials that prevent microbial adherence. Examples of other tubes include endotracheal tubes, oral or naso-gastric tubes, suction catheters, and chest-tubes or other catheters used for drainage purposes. The applications need to focus on methods to improve the performance quality of such tubes, catheters, and accessories that ultimately lead to reduced microbial colonization and reduced incidence of health-care and device-associated sepsis, reduced thrombogenic properties, and/or prevention of other device-associated complications.  Applications may also include studies to improve the accuracy and speed of bacterial and fungal septicemia diagnoses, rapid identification of pathogenic microbial organisms, and assessment of antimicrobial resistance/susceptibility characteristics utilizing small volumes of blood and/or other biological fluids.

Hearing, speech, and swallowing functions:  Devices and instruments for assessment and preservation of hearing (e.g., improved auditory brainstem response technologies to provide continuous monitoring and effective noise cancellation to reduce incubator noise) and speech/swallowing functions (e.g., improved oro-cutaneous stimulation devices and  improved therapeutic devices to facilitate oral motor development and sucking capacity in premature infants and in infants with developmental/intellectual disabilities).

Radiological Devices: Device development to reduce the harm from radiation exposures, especially during CT.