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April 8, 2014

Fast, cheap test can help save lives of many babies

Olivia Easley gave birth to her third child on April 26, 2009. The baby appeared pink and healthy, nursed well and had gained weight by her first doctor's visit.

But when the baby, Veronica, was about 6 weeks old, she started having difficulty nursing, seemed to be in pain and began vomiting. Her pediatrician thought it might be reflux and suggested that Easley, a physician from Bethesda, Md., who works for the Food and Drug Administration, change her diet.

When things hadn't improved a few days later, Easley scheduled another trip to the pediatrician. That evening, she put Veronica down for a nap after nursing her. Easley heard a bit of crying about an hour later and then silence. Going into the baby's room to check on her, Easley found Veronica flipped onto her stomach. She turned her over - and discovered that her child was not breathing.

"Finding her dead - it's unimaginable," Easley said. "I felt like the floor was ripped out from under me - suddenly floating - you want to escape, and this must be a horrific nightmare. Just seconds before, my life was great and now I'm in hell, and how did this happen?"

Veronica Easley, the medical examiner said, died of total anomalous pulmonary venous connection (TAPVC), one of the heart defects that make up critical congenital heart disease.

 "The medical examiner said it was amazing she lived seven weeks," Easley said. "I was relieved they found something on autopsy, but when I learned more of her condition and that it could have been fixed, I got really angry."

Here's why. As Easley did more research into her daughter's death, she learned that a pilot program had started just months earlier at Holy Cross Hospital in Silver Spring, Md. (Easley had delivered at a different hospital in the Washington area.) The program's goal was to screen every newborn with a simple pulse oximeter test that can help detect heart problems such as Veronica's, allowing doctors to respond. About 40,000 U.S. babies are born every year with congenital heart defects, 400 of them with the deformity that killed Veronica.

The pulse oximeter is a hand-held device that uses a sensor clipped to the fleshy part of a hand or foot to measure oxygen saturation in the blood. It provides noninvasive and low-cost screening that can help detect congenital heart defects that often are associated with abnormally low levels of blood oxygen. According to the American Heart Association, the test takes as little as 45 seconds. When the screening identifies newborns with low oxygen saturation, additional tests can be done to identify and respond to the problem. Pulse oximeters sell online for as little as around $30 for a simple model to more than $200 for a hospital-grade model.

"Congenital heart defects affect one in every 100 live births," said Gerard Martin, a pediatric cardiologist who is senior vice president of the Center for Heart, Lung and Kidney Disease at Children's National Medical Center. If children with critical congenital heart disease do not receive treatment within the first weeks or months of life, the risks of harm or even death can be very high, Martin said. "It's very important for us to find these babies early. If we find them, we can save 98 to 100 percent."

Dylan Coleman, who was born in 2012, may owe his life to the use of a pulse oximeter. His mother, Michelle, delivered the infant at Holy Cross without incident, but as she and her husband were preparing to bring Dylan home two days later, they were told a pulse oximetry test had raised a red flag. (Maryland has required that hospitals administer the tests since 2011.) The hospital performed an echocardiogram that day; when it showed some aortic problems, Dylan was whisked away to Children's for further treatment and surgery. Two weeks later he was discharged and is now doing fine, Coleman says.

"If we had delivered in (Washington) D.C., where we live, he would have been discharged - [hospitals in the District] were not testing at the time," Coleman said. Doctors told her Dylan most likely would have gone into congestive heart failure and died within 48 hours, of being discharged, Coleman said.

Martin said all District hospitals now use pulse oximetry screening as part of a project initiated by Children's. An advisory panel has recommended that the test be mandated.

 Martin said studies 15 years ago first showed the promise of pulse oximetry in detecting cardiac defects in newborns, but more research needed to be done to make the case. A 2009 study of nearly 40,000 infants in Sweden concluded that pulse oximetry screening before discharge was a cost-effective and quite reliable way of detecting potentially serous cardiovascular problems in newborns.

Martin said that in 2009-2010 Children's pulled together pediatricians, neonatologists, nurses, obstetricians and representatives of the FDA, the National Institutes of Health and the Centers for Disease Control and Prevention to look at the issue. The result was a recommendation that the federal government put pulse oximetry on the official list of tests that doctors should regularly perform on newborns. That recommendation was adopted in 2011.

Indiana and Maryland were the first states to mandate universal screening in 2011. As of the beginning of this year, 35 states, including Virginia, have passed legislation requiring testing.

Martin says it's important to get such legislation on the books. "It's a problem that it is not a mandate because this could all go away," he says. "And it doesn't cover the 5 to 6 percent of babies delivered by midwives."

Mairi Breen Rothman of M.A.M.A.S. (Metro Area Midwives & Allied Services) said her organization added pulse oximeters to its Washington area practice a few months ago.

"We felt it was important after Maryland [passed the law requiring pulse oximetry]. We are diligent in our care of babies and didn't want our babies falling through the cracks," said Breen Rothman, a certified nurse-midwife for 18 years.

For Martin, getting people to adopt the test is a no-brainer. Pulse oximetry costs no more than about $1 per baby, yet that early intervention can change lives. "We want to fix them early and fix them right," Martin says.

               

Berger is a freelance journalist who writes about health issues.



 

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