TEL AVIV, Israel, March 23, 2021 /PRNewswire/ -- Nuvo Group Ltd.—a private company commercializing INVU by Nuvo™, an FDA-cleared, prescription-initiated, remote pregnancy monitoring platform—today announced that it has partnered withDr. Liz Conradt and Dr. Sheila Crowell, directors of the Child Adaptation and Neurodevelopment (CAN) Lab—part of the University of Utah's Department of Psychology—on a study to better understand how prenatal maternal distress is related to children's health outcomes. Supported by a National Institute of Mental Health (NIMH) grant, the study, titled the Baby Affect and Behavior (BABY) Study, plans to analyze maternal and fetal heart rate variability (changes in the amount of time between heartbeats)—as measured by INVU—in relation to "emotion dysregulation," which can occur when an individual is under stress or struggles to regulate his or her emotional responses to support effective behavior. The research is currently underway, with full results expected in 2023.
According to Drs. Conradt and Crowell, children begin to develop physical, emotional and behavioral attributes (e.g., susceptibility to chronic diseases or mental health disorders) while in utero. These attributes are partially "programmed" based on the mother's emotional prenatal experiences, which may include stressful situations that impact one's heart rate. To better understand this connection, the CAN Lab is using INVU to measure maternal and fetal heart rate variability across more than 200 women in their third trimesters of pregnancy. Study participants span the full range of emotion dysregulation and are being studied for a total of 18 months (pre- and post-birth).
This study is the first time INVU is being used to analyze both fetal and maternal heart rate variability based on the maternal and fetal electrocardiogram (ECG) and phonocardiogram (PCG). Nuvo's technology enables the CAN Lab to accurately and remotely capture the fetal and maternal interbeat interval, a critical component in heart rate variability, which currently cannot be captured using standard methods such as cardiotocography (CTG). This precise data may ultimately allow the research team to predict the impact of the mother's emotional state during pregnancy on the child's health outcomes.
In addition to allowing for more refined measurements, INVU's remote capabilities allow study participants to measure maternal and fetal heart rates from home, enabling the study to continue during the COVID-19 pandemic. The use of remote monitoring has also given the CAN Lab an opportunity to diversify its participants to include women who would otherwise not be able to accommodate an in-person study due to location or other limitations.
"Through this study, we hope to advance the science and technology of prenatal programming research to predict health outcomes earlier and more accurately," says Dr. Crowell. "This partnership with INVU is marked by some important 'firsts'—it's the first time we've been able to analyze the correlation between maternal-fetal heart rates and emotional dysregulation this precisely, and because of INVU's remote technology, it's also the first time we've been able to extend our research beyond a lab setting. These are significant steps toward our ultimate goal of identifying important developmental periods and individual traits as early as possible in order to prevent the possible maladaptive health effects of prenatal stress exposure during a child's early life."
"INVU has been developed to allow expectant mothers to monitor maternal-fetal health from anywhere under the supervision of their physicians," says Amit Reches, chief technology officer, Nuvo Group. "We are thrilled to see our measurement and data capture tools being used in a new and unique way through this partnership with the CAN Lab. At Nuvo, this is what we envision for the future of maternal-fetal health—a holistic approach that brings together a variety of providers and disciplines to ultimately improve the health of future generations."
INVU is the first FDA-cleared remote pregnancy monitoring platform that allows expectant mothers to monitor maternal-fetal health from anywhere under the supervision of their physicians. The physician prescribes INVU to the mother, who wears the INVU sensor band during virtual visits. During these visits, a live reading allows the mother to access simplified data and insights via the paired INVU app, while the provider receives fetal and maternal heart rate tracings comparable to the fetal viability checks that normally occur in prenatal visits. INVU is designed to integrate with other peripheral devices, such as blood pressure cuffs, allowing the mother to easily record and track important vitals for her provider to review all on one app.
About Nuvo Group Nuvo Group is committed to serving providers and expectant mothers by advancing pregnancy care with new technology, tools and practices. The INVU platform combines proprietary hardware for data collection, innovative cloud-based software for computational power and AI tools to optimize the pregnancy care experience on a global scale. INVU has received 510(k) clearance from the U.S. FDA for maternal and fetal heart rate monitoring, and has a 510(k) pending for remote monitoring of maternal uterine activity in the United States. Company leadership is composed of dedicated data engineers, experienced medical and business professionals, software designers and proud parents who embrace a collective mission to give every life a better beginning.
For more information and complete current indications, contraindications, warnings and precautions along with instructions for use, visit: www.nuvocares.com
About CAN Lab Directors Dr. Elisabeth Conradt and Dr. Sheila Crowell Dr. Conradt is an associate professor of developmental psychology at the University of Utah. Her expertise is in early life stress and neurodevelopment. Dr. Crowell is an associate professor of clinical psychology at the University of Utah. She brings expertise in maternal mental health, emotion dysregulation, heartrate variability and risk for the development of psychopathology. Drs. Conradt and Crowell began collaborating in 2014 to better understand how maternal health and wellbeing can affect infant and child emotional and physical health outcomes. This work has been funded by multiple NIH grants and awards from the University of Utah. The ultimate goal of their program of research is to improve mental health within families through research, clinical care and advocacy.