Med-Tech Newborn Foundation Saves Thousands of Newborn Lives

How one mother changed the screening process for early detection of heart defects, saving thousands of lives.

Med-tech startup saves the lives of the most vulnerable by advocating universal screening tests.

By  Lee Masterson and Anne Howard
Minnesota-based Annamarie Saarinen is the mother of a little girl who was born with congenital heart defects that the doctors didn’t recognize during the initial physical exam at birth. Despite the fact that the baby’s heart was nearly three times the size it should have been, the doctors simply didn’t see that she was sick at birth, and almost sent Annamarie home with her ‘healthy’ newborn baby girl. It wasn’t until baby Eve was three days old that her congenital heart defects were diagnosed by a rounding pediatrician that heard a murmur, and found there was on the premise- by sheer coincidence- a pediatric echocardiography technician at the hospital that afternoon evaluating another baby. Following the echocardiography, Eve was rushed to a NICU at another hospital. Annamarie has since learned that an astounding 40% of heart defects go undetected during the physical exam in the nursery, due primarily to three components. Newborns can appear healthy while the ductus arteriosus remains open, there is no murmur or visible cyanosis, and the practice of early hospital discharges before visible signs or symptoms appear.

As a direct result of receiving such a devastating diagnosis for her newborn daughter, Annamarie, who has a background in public affairs-  embarked on a mission to improve the screening process for newborns right across the country, and the world. After Eve recovered from her heart surgeries, the Minnesota Newborn Heart Screening project was born. It looked at a technology that already existed but in a whole new way.  

Annamarie Saarinen
Annamarie Saarinen visiting a NICU.

Speaking exclusively with Scope Weekly, Saarinen said, “When Eve was first diagnosed, rallying the pilot research project was key. We did the first multi-hospital pilot in collaboration with a department of health. That data helped inform the US Secretary of Health and Human Services – and with our advocacy helped ensure CCHD screening was added to the newborn screening panel for all 4 million babies born in this country each year.  To date, 22 million US babies have been screened and millions more internationally.”

Partnering with Masimo, an American manufacturer of noninvasive patient monitoring technologies based in Irvine, California that holds the patent on Signal Extraction Technology (SET), the Newborn Heart Screening project has adopted it and co-launched the first mobile-phone based pulse oximeter.
Masimo and the Newborn Foundation developed the first mobile-phone based pulse oximeter.

Saarinen said,”We worked closely with Masimo in 2012 to develop the world’s first mobile-phone based pulse oximeter, which has literally transformed the landscape for delivery hospitals in resource-poor settings. It reduced the cost of screening by nearly 10-fold. We also worked with Masimo on a project funded by the Bill and Melinda Gates Foundation to develop the first combined diagnostic device that measures both Sp02 (oxygen saturation) and respiratory rate in children. The device is also aimed at low-resource settings and reducing preventable deaths from late diagnosis of pneumonia, the number one killer of children under 5.”

Thanks to the hard work and dedication of the St. Paul-headquartered Newborn Foundation, the lives of roughly 4,200 U.S. babies have been saved or significantly improved because of their screening initiatives.

It’s estimated that 11,000 babies die every day before they are even one month old. Most of those babies die within the first tentative days of life. In just a few short years, the Newborn Foundation has literally helped to save thousands of lives.

From its humble beginning in Minnesota, the Newborn Foundationhas grown to occupy a global presence and has changed the landscape of point-of-care screening of newborns in remote areas and the U.S.

Saarinen says, “The organization’s subsequent pilot work and advocacy resulted in the U.S. addition of newborn pulse oximetry screening (Critical Congenital Heart Disease – CCHD Screening) to the Department of Health and Human Services’ universal screening panel.”

“Following this, the Newborn Foundation began working with China, the Philippines, and other countries to establish pilot programs, defining best practices for screening well-appearing newborns.”

Saarinen’s daughter, Eve, is now nine years old. Despite the fact that Eve was also diagnosed with a brain tumor in 2013, the brave little girl has traveled with her parents to two international projects, meeting children and families who have also survived medical crises and inspiring people with her story.

What Is the Newborn Foundation?

The Newborn Foundation is dedicated to leveraging and developing technological innovations to save newborn lives. The organization also strives to find innovative ways to improve health outcomes through early detection and intervention for a broad range of newborn health conditions.

Saarinen says, “The organization advocated for universal pulse oximetry screening on well-appearing newborns as a way of earlier detecting heart defects and other serious health issues. We estimate more than 4,000 lives have been saved through early diagnosis since screening was implemented in the U.S.”

Pulse oximetry screening is meant to identify babies with conditions manifesting with hypoxemia (low oxygen saturation), including congenital heart defects (CHD), Critical Congenital Heart Defects (CCHD), sepsis, pneumonia, pulmonary hypertension (PPHN) and other asymptomatic respiratory problems. The device is also aimed at low-resource settings and reducing preventable deaths from late diagnosis of pneumonia, the number one killer of children under 5.

Research and Development

Not resting on its laurels, the med-tech startup has an extensive research branch. and Annamarie shared with us some of its latest development, “Our research portfolio now spans into biotech, research on neonatal infection, nutrition and pain management. Additionally, our Innovation Incubator has been responsible for the development of 3 new medical devices to aimed at addressing unmet needs for newborns in the U.S. and overseas (we hold IP on two of these). One of these is under the project name “whoosh” – a diagnostic imaging device for babies and pediatric patients that essentially automates echocardiography.”

The BORN Project

The BORN Project stands for Birth Oximetry Routine for Newborns. It’s an education-and-implementation model providing clinical education, data, and a screening framework leveraging the first low-cost, clinical-grade, commercialized mobile phone pulse oximeter designed for accurate measurements of hypoxemia in newborns.

Saarinen explains, “While some heart defects are detected prenatally through ultrasound, a significant portion remains undetected before birth. Newborn physical exams in the nursery fail to detect more than 40% of heart defects primarily because newborns can appear healthy while the ductus arteriosus remains open because there is no murmur or visible cyanosis, or due to early hospital discharges before visible signs or symptoms appear.”

The project is now active across ten countries and provides actionable data to clinicians and policy-makers on the effectiveness of pulse oximetry screening for newborns.

As a 501(c)(3) organization, the Newborn Foundation continues to advocate groundbreaking tech-based pilot projects that directly impact early detection and interventions for the most life-threatening newborn health conditions.

Saarinen says, “In our seven years, we have raised approximately $2.9 million in grant-based research funding and donor support” She adds,” It’s critical for healthcare service providers to be able to respond quickly. Nearly 41 percent of all under-five child deaths are among babies in their first 28 days of life; this makes the availability of neonatal intensive care units vital in those first hours and days of an infant’s life.”

You can support the Newborn Foundation’s initiatives and efforts to combat newborn mortality by donating here.

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