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Long Term Pulse Oximeter Monitoring for Neonates with Chronic Disease

Award Number: R44HL112460
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2012
PERIOD OF PERFORMANCE END DATE: 07/31/2021

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Long Term Pulse Oximeter Monitoring for Neonates with Chronic Disease - DESCRIPTION (provided by applicant): This project aims to develop continuous pulse oximetry monitoring technology to facilitate the care of infants after they have transitioned from the neonatal intensive care unit (NICU) to home. This technology targets the monitoring of neonates with chronic lung disease of infancy (CLDI), a group of respiratory diseases that usually evolves from an acute respiratory disorder experienced by a newborn infant. Advances in perinatal care, changes in health care economics, and research suggesting a negative impact of prolonged hospitalization on development of the preterm newborn have influenced discharge practices for infants with CLDI. The home environment has increasingly been recognized as the optimal setting for medically stable, technology assisted infants to receive the complex and demanding care they require. Infants in the NICU are commonly connected to multiple pieces of equipment and monitors. While this lifesaving technology is a necessary part of providing care to these infants, the many wires can also add to the complexity of caring for these infants, particularly in a home environment with untrained personnel. Very recent advances in electronic components allow miniature wireless medical instrumentation to be developed that is of a size and weight appropriate for a long-term wearable neonate application. This project includes a unique team of medical device experts with a history of FDA approved products, research neonatologists, pulse oximetry design experts, and a human factors expert. Testing will include FDA recommended 510(K) safety and performance evaluations, a desaturation study, and a gold standard comparison evaluation in neonates.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2017	ADVANCED MEDICAL ELECTRONICS CORP	6901 E FISH LAKE RD	MAPLE GROVE	MN	55369	HENNEPIN	USA	Lung Diseases Research	000	3	2/1/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2017	ADVANCED MEDICAL ELECTRONICS CORPORATION	6901 E FISH LAKE RD STE 190	MAPLE GROVE	MN	55369	HENNEPIN	USA	Lung Diseases Research	000	3	8/20/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2017	ADVANCED MEDICAL ELECTRONICS CORPORATION	6901 E FISH LAKE RD STE 190	MAPLE GROVE	MN	55369	HENNEPIN	USA	Lung Diseases Research	000	3	8/2/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $806,260 )
2017	2017	ADVANCED MEDICAL ELECTRONICS CORPORATION	6901 E FISH LAKE RD STE 190	MAPLE GROVE	MN	55369	HENNEPIN	USA	Lung Diseases Research	000	3	7/20/2017	NON-COMPETING CONTINUATION	$806,260
														Subtotal = $806,260

Issue Date FY: 2016 ( Subtotal = $693,210 )
2016	2016	ADVANCED MEDICAL ELETRONICS CORP	7124 ARROWWOOD LANE	MAPLE GROVE	MN	55369	HENNEPIN	USA	Cardiovascular Diseases Research	000	2	7/31/2016	COMPETING CONTINUATION	$693,210
														Subtotal = $693,210

Grand Total All Awards = $1,499,470

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Long Term Pulse Oximeter Monitoring for Neonates with Chronic Disease

Award Number: R44HL112460

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2012

PERIOD OF PERFORMANCE END DATE: 07/31/2021

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