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NONA Garment Project: Noninvasive Observation of Natal Activity

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
93877
Program Year/Program:
2009 / SBIR
Agency Tracking Number:
HD059263
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
Orbital Research Inc
4415 Euclid Avenue Suite 500 Cleveland, OH 44103-3757
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2009
Title: NONA Garment Project: Noninvasive Observation of Natal Activity
Agency: HHS
Contract: 1R43HD059263-01A1
Award Amount: $181,545.00
 

Abstract:

DESCRIPTION (provided by applicant): Named NONA, after the Roman God of pregnancy this innovative system will monitor the expectant mother to mitigate the risk to mother and child during birth. During this Phase I project, Orbital Research Inc. (Cleveland, Ohio), with their partners at MIT, Tufts-New England Medical Center and E-Trolz, Inc., intends to build, then test a novel fetal electrocardiograph (FECG) monitoring system. The fetal ECG harness device will be a large sensor array that can be applied in a convenient and rapid manner to an expectant mother. The garment-based sensor array will allow sensors to be placed in anterior, posterior and lateral positions on the mother in a single step. The garment will leverage the Orbital Research dry, ECG record ing electrodes1, the E-Trolz embedded platform, and signal processing expertise from the laboratory for computational physiology at MIT. The proposed non-invasive fetal monitor will reliably acquire fetal ECG signals, and identify characteristic ECG patter ns that predict impending fetal injury caused by inflammatory, hypoxic, or ischemic insults. During this Phase I project, Orbital Research Inc (Cleveland, Ohio), with their partners at the Massachusetts Institute of Technology, Tufts Medical Center, and E- Trolz, Inc., will build, test and demonstrate the feasibility of a novel fetal electrocardiograph (FECG) monitoring system. The ultimate program goal (after completion of Phase II) is to produce a reliable, inexpensive, non-invasive system for fetal monito ring during pregnancy and labor. The information gained from this system will mitigate risk to the mother and fetus during delivery which will dramatically improve clinical outcomes especially from high risk deliveries. 1 FDA cleared. The ORI F6T Dry ECG E lectrode is intended for use in all ECG monitoring applications where standard ECG monitoring electrodes are used. The F6T Electrode can be used in short term and long term (up to 2 days) ECG monitoring. PUBLIC HEALTH RELEVANCE: The ultimate goals of this NONA (Non-Invasive Observation of Natal Activity) program are: 1) To develop a reliable, inexpensive, non-invasive system for fetal monitoring during pregnancy and labor, and 2) to identify FECG characteristics that predict adverse events during labor and the immediate postpartum period. The Phase I program outcome will be the demonstration of the feasibility of the complete system - garment- sensors, hardware, and algorithms to identify health risk to the child during childbirth. Upon successful completion of the Phase I program, the Orbital Team will have: fabricated several disposable garments with integrated sensors, captured data from a set of women in the birthing center at TUFTS- New England Medical Center, and demonstrated fetal heart rate and components of FECG can be identified accurately using Kalman Filtering relative to the available truth markers collected via the scalp sensor.

Principal Investigator:

Aaron T. Rood
2166490399
SNYDER@ORBITALRESEARCH.COM

Business Contact:


snyder@orbitalresearch.com
Small Business Information at Submission:

ORBITAL RESEARCH, INC.
ORBITAL RESEARCH, INC. 4415 EUCLID AVE, STE 500 CLEVELAND, OH 44103

EIN/Tax ID: 341672688
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No