Category: News & Updates

After a popular app stopped receiving medical data, some families wondered how reliable monitoring is.

It’s a question almost all new parents have asked themselves while peering into their child’s crib or bassinet: Is my baby breathing?

Worried by the rare but frightening possibility of sudden, unexpected infant death, some families are using electronic devices that allow them to not only watch their babies’ movements and listen for signs of distress, but to track health data like their pulse and the oxygen levels in their blood.

On the surface, such devices may seem like a godsend for bleary-eyed parents: It’s impossible to watch a baby continuously for 24 hours, so why not use technology like cameras and motion sensors to ease worried minds? But experts say that these devices — particularly ones that collect medical data — aren’t always reliable and can end up making new parents even more anxious.

Case in point: the widespread spiral of frustration that ensued last weekend after the Owlet Smart Sock — a popular product that wraps around a baby’s foot to record sleep patterns, oxygen levels and heart rate — stopped communicating with the Owlet phone app.

The Smart Sock uses light to measure a baby’s pulse rate and blood oxygen levels. It sends data via Bluetooth to the product’s base station, a small device that must be within 100 feet of the sock. If the baby’s vitals are normal and the device is working properly, the base glows green. If something goes wrong — if the sock is poorly positioned, for example, or if a baby’s blood oxygen dips to an abnormal level — the base station will emit sounds and colored lights that signify what the problem is. At the same time, these live vital sign readings and alerts are sent via Wi-Fi to parents’ phones through the Owlet smartphone app.

Owlet said that the disruption, which began last Thursday, stemmed from a bug in a new release of its app that caused its servers to crash. When the servers went down, parents were no longer able to see their child’s heart rate or oxygen levels on the company’s app, Kurt Workman, Owlet’s chief executive officer, said in a video statement that was uploaded to Facebook on Saturday.

“I just want to take a moment to apologize to each and every one of you for this tremendous inconvenience that we’ve caused,” said Mr. Workman, a father of three who said he uses the Smart Sock to monitor his 9-month-old.

On Sunday, Owlet said it had fixed the problem, but by then hundreds of parents had shared their frustrations on social media. Nearly 900 comments flooded the company’s Facebook page. (On Wednesday, the comments appeared to have been removed and were no longer visible.)

“Hi, we have loved your product for about 5 months. However the last month has been extremely tough,” one father wrote, adding that the product has triggered alarms multiple times “for no reason” and has caused “more anxiety than relief.”

Others voiced their complaints on Twitter.

Courtney Bartlett, 25, of Harrisville, W. Va., asked for better communication from the company. “Maybe email users in the future if you can’t have a notice in the app?” she wrote.

Would be nice to have been notified of this so I wasn’t trying to get it to connect for an hour at 3am. Maybe email users in the future if you can’t have a notice in the app?— Mithrandir

“We put our child to bed at 8 o’clock and trusted the app to monitor him all night,” Jordan Young, 33, the father of a 7-month-old who lives in Nashville, said in an interview on Monday. “And at some point in the middle of the night, the app lost connection to the base station. I was never any wiser until well into the next day.”

The Smart Sock seemed like a good investment to ensure his son’s safety while he slept. But Mr. Young began questioning why his family was using a device with an app that could create what he called “a false sense of trust.” If the app on your phone isn’t working, the base station will still light up and make sounds if something goes wrong, he said, but that’s only useful if you’re sleeping near it.

Doctors have also become skeptical of the accuracy and reliability of health-tracking monitors like the Owlet Smart Sock, which debuted in 2015 and retails for $299. When purchased with the Owlet camera, the bundle costs $399.

A 2018 study published in the Journal of the American Medical Association, for instance, found that the Owlet Smart Sock 2 (the device currently on the market) and a similar device made by Baby Vida, which is currently unavailable, displayed certain inaccuracies when tested on 30 infants who were hospitalized at the Children’s Hospital of Philadelphia. The researchers compared results from the two products with a Food and Drug Administration-cleared device that measures oxygen levels in the blood.

While the Owlet device correctly detected abnormally low oxygen levels in the blood, it didn’t perform consistently, according to the study, and in several instances it falsely displayed problematic pulse rates when the reference monitor showed normal pulse rates. The Baby Vida, on the other hand, falsely displayed low pulse rates and never detected instances where oxygen levels became abnormally low.

Dr. Christopher P. Bonafide, a pediatrician at Children’s Hospital of Philadelphia who co-authored the study, said on Tuesday that the various problems consumers encounter with these products speak to “the fragile state of unregulated consumer health tech.”

Because these are consumer devices, neither went through the rigorous F.D.A. approval process that is required of hospital-grade medical devices, Dr. Bonafide said, and as a result, their “accuracy and reliability have not been scrutinized to the same degree.”

The Owlet might seem like a medical device, but — as the manufacturer clearly states on its website — it is “not as stringent as a medical monitor” and “only intended to assist you in tracking your baby’s well-being.”

Medical devices used in hospitals are quite different, in part because they’re routinely checked to make sure that they’re working properly, said Dr. Elizabeth Murray, a pediatric emergency medicine physician at the University of Rochester Medical Center, who said she often sees children whose parents have received a false-positive alarm from a monitoring device.

“I do frequently see parents coming into the emergency department with a wonderful, healthy, beautiful baby — but the alarm has triggered, and so they’re terrified that something awful might have happened to their child,” Dr. Murray said, adding that she worries about the “additional angst and stress” these devices can sometimes cause.

A sound monitor or even a video monitor is “totally appropriate and fine,” she said, but “the chances of error are very, very great” when monitoring heart rate and oxygen saturation. “I think that your money is better spent elsewhere.”

Continuously monitoring healthy infants can lead to overdiagnosis, according to an editorial co-authored by Dr. Bonafide that appeared in JAMA in 2017. Studies have shown that healthy infants can experience oxygen levels that occasionally dip below 80 percent and are not a cause for alarm, the authors said.

To ensure that your baby is safe, the American Academy of Pediatrics recommends that parents sleep in the same room as their infants for at least the first six months or, ideally, the first year of the baby’s life. In addition, babies should be placed to sleep on their backs in a crib with a firm sleeping surface with nothing other than a tightfitting, thin sheet, to help prevent sleep-related death.

While the rate of sudden, unexpected infant deaths has declined since the emergence of public health campaigns encouraging safe sleep training, there are still approximately 3,500 babies in the United States who die suddenly and unexpectedly each year from accidental suffocation, Sudden Infant Death Syndrome or unknown causes, according to the Centers for Disease Control and Prevention.

The academy’s policy statement on safe sleep says there is no data indicating that SIDS can be prevented by using at-home monitors that track heart rate and blood oxygen levels.

Even so, companies that promise to ease parents’ minds are profiting.

The global baby monitors market size is projected to reach $1.63 billion by 2025, according to a 2017 report from Hexa Research, a market research and consulting firm. The North American region accounted for almost half of global sales in 2016, the report said.

In 2017, Owlet earned $25 million in revenue, according to the business magazine Inc. When asked about the company’s 2018 earnings and the number of socks sold, Mr. Workman declined to comment.

A class-action lawsuit filed in April accused Owlet of using false and deceptive marketing practices, claiming that its Smart Sock regularly gives false alarms and fails to detect abnormal heart rates or oxygen levels.

Mr. Workman said in a statement that the company disputes the allegations.

“Owlet is transparent in how its products work and looks forward to being vindicated in court,” the statement said.

Despite any technical difficulties, a working Owlet still provides reassurance to Ms. Bartlett.

She plans to keep using the Smart Sock on her 2-month-old son, even though she said that the monitor has trouble connecting to her phone and once sounded a false alarm in the middle of the night, indicating the sock was positioned incorrectly.

“For me, I just like the peace of mind of being able to check on my phone and see, yeah, he’s O.K.,” she said. “I just know that it’s not going to work as much as it should for the price.”

Mr. Young, the father of the 7-month-old, agreed.

“I would buy it again, I think,” he said. “But I don’t know that I would put as much trust into it as I have.”

In the end, he added, “nothing can replace good parenting, you’ve just got to find some things to help you.”

Thousands of infants die unexpectedly each year, and experts are working to figure out why.

It’s every parent’s worst nightmare: You put your healthy infant to bed, but your child never wakes up.

Dr. Richard Goldstein, M.D., a pediatric palliative care specialist at Boston Children’s Hospital, has watched this tragedy unfold hundreds of times; and according to Dr. Goldstein, it never gets easier. “These parents have such profound suffering,” he said. “It’s a peculiar and sad little corner of medicine.”

In 2017, 3,600 infants died suddenly and unexpectedly, according to the latest data from the Centers for Disease Control and Prevention. Of those, about 1,400 were believed to have died from Sudden Infant Death Syndrome, or SIDS — a catchall term for when an infant under 1 year of age dies, often while sleeping, with no specific environmental or medical cause.

Despite the fact that SIDS is the third leading cause of infant death, however — behind birth defects and prematurity — experts are still puzzled as to exactly how it kills, said Dr. Michael Ackerman, M.D., Ph.D., a genetic cardiologist at the Mayo Clinic.

But Dr. Goldstein, Dr. Ackerman and a small cadre of other researchers are hoping to chip away at that uncertainty by studying the biological underpinnings of this puzzling syndrome. Their work promises both to give parents much-needed explanations for why their children died, and to prevent additional SIDS deaths from occurring in the first place.

“We’ve been making big progress by looking at how a cloud of factors come together in a perfect storm,” said Dr. Nino Ramirez, Ph.D., a neuroscientist at the University of Washington. “Every SIDS child has a unique history, but we can identify common risks by letting the data speak.”

A SIDS diagnosis

Before the 1960s, healthy infants who had died seemingly suddenly or inexplicably were said to have died from “asphyxiation” or “unexplained causes.” But it wasn’t until the late ’60s and ’70s that experts formally defined and recognized the diagnosis of “SIDS.”

What put infants most at risk, however, was a mystery. Babies born into poorer families or to mothers who smoked during pregnancy and after the birth, for instance, seemed to be more likely to die from SIDS than their more affluent counterparts who lived in smoke-free environments. But as scientists teased apart its potential risk factors, one seemed to outweigh the others: Babies who had died from SIDS were much more likely to have been put to sleep on their stomachs.

Infants who sleep facedown rebreathe the same air over and over again, researchers hypothesized, depleting it of vital oxygen and leaving it with higher levels of carbon dioxide. If newborns can’t rouse themselves when this happens (as babies younger than 6 months can struggle to do), the thinking went, they could suffocate.

In 1994, the National Institute of Child Health and Human Development began the “Back to Sleep” campaign, which encouraged parents to place their infants to sleep on their backs at nap- and bedtimes. Within 10 years, SIDS deaths in infants plummeted from more than 5,000 per year in the 1990s to between 2,000 to 3,000 deaths each year in the early 2000s.

But by the mid-2000s, that decline in SIDS deaths stalled, and a small but persistent number of babies continued to die in their sleep. While scientists were successful in identifying certain factors that might increase an infant’s risk of dying of SIDS, said Dr. Peter Blair, Ph.D., an epidemiologist at the University of Bristol in the United Kingdom, “we don’t really know the ultimate causes of these deaths.”

SIDS remained distressingly, and perplexingly, random; and its causes much harder to pinpoint.

Is the brain to blame?

In her work as a neuropathologist at Boston Children’s Hospital in Massachusetts, Dr. Hannah Kinney, M.D., saw many unexplained infant deaths. If she could understand what caused them, Dr. Kinney reasoned, she might be able to prevent them.

In the 1980s, Dr. Kinney found that infants who had died of SIDS had showed cellular signs of damage in the part of the brain that controls breathing. As she homed in on the thick, stemlike structure in the brainstem called the medulla oblongata, she noticed that about 40 percent of the brains of babies who had died from SIDS had produced unusually low levels of the neurotransmitter serotonin.

Serotonin is famous for its links to mood, but it also plays a role in controlling breathing, heart rate, blood pressure, temperature regulation and arousal from sleep. When Dr. Kinney and Dr. Susan Dymecki, M.D., Ph.D., a neuroscientist from Harvard University, engineered mice with the same serotonin deficiencies as seen in the brains of babies who had died of SIDS, these mice didn’t gasp and resuscitate themselves in low-oxygen, high-carbon dioxide environments. Instead, “they just lied there and died,” said Dr. Goldstein.

In 2018, Dr. Dymecki and her colleagues published a follow-up study in the journal eLIFE, which demonstrated that blocking the activity of serotonin neurons in the brainstems of mice prevented them from returning to a normal breathing pattern after they temporarily stopped during sleep.

In other words, Dr. Dymecki’s mice behaved exactly like babies who had died from SIDS, bolstering the idea that serotonin deficiencies are at least partly to blame for some SIDS deaths.

Halfway around the world in Australia in 2017, a team of researchers including Dr. Fiona Bright, Ph.D., then a neuroscience doctoral student at the University of Adelaide, began finding other neurotransmitter abnormalities in the brainstems of SIDS babies. Specifically, she found defects in the brain pathways that regulated breathing and recognition and response to low oxygen levels (which relied on the neurotransmitters serotonin and substance P). These abnormalities, Dr. Bright found, significantly impacted babies’ abilities to rescue themselves when struggling to breathe during sleep, and were especially pronounced in premature and male infants — two of the highest risk groups for sudden unexpected infant death.

Between Dr. Bright’s work in Australia, ongoing work in Boston and other global research efforts into the causes of SIDS, it became clear that certain babies had an innate biological risk for the syndrome. “During sleep, most infants can wake themselves up,” said Dr. Bright. “SIDS babies don’t have this ability.” Combine that underlying biology with a 6-month-old (whose other arousal brain circuits have yet to fully mature) and an environmental stressor such as soft bedding or secondhand smoke, and this triple risk can coalesce into the perfect storm.

A defect in the DNA?

Other scientists began finding that babies who’d died of SIDS had specific mutations in their DNA. In fact, recent studies suggest that upward of 20 percent of SIDS deaths may have been due to inherited or genetic conditions.

In 2018, Dr. Ackerman of the Mayo Clinic published a study in the Journal of the American College of Cardiology which analyzed the genomes of 419 babies who had died from SIDS. He found that 5 percent carried mutations in a set of genes involved in sudden cardiac death. (Five percent might seem like a relatively low number, but according to Dr. Ackerman, the results are significant.)

Others have found links between SIDS and mutations in genes that play roles in metabolism, inflammation, development and epilepsy, underscoring the syndrome’s complexity.

An undiagnosed disease

Despite emerging research, Dr. Goldstein and Dr. Kinney still hadn’t been able to provide grieving parents with suitable explanations for how their children died. In 2014, the pair launched a clinical program and research study at Boston Children’s Hospital, which performs genetic testing and detailed clinical case reviews for children in Massachusetts who died of uncertain causes before age 3. In essence, the duo decided to treat SIDS like an undiagnosed disease.

In 2017, they found explanations for 16 of the first 17 deaths in the program, which had initially been blamed on SIDS or Sudden Unexplained Death in Childhood (unexplained death in children older than 1 year). These results — which included undetected infections, unusual birth defects and rare genetic mutations — not only provided answers for bereft parents but may have also prevented additional deaths. In one case, an epilepsy-causing mutation that was identified in a SIDS baby was also found in the child’s sibling, who was then placed on anti-seizure medications. A March 2019 paper in Trends in Neurosciences also highlighted the close links between SIDS, S.U.D.C. and epilepsy, suggesting that the conditions may share a similar neurobiology.

Other studies have also begun to pinpoint potential SIDS causes. A study published in April 2019 in the journal Pediatrics, for instance, found that mothers who smoked during their pregnancies were twice as likely to have babies who died of SIDS as nonsmokers were.

Although scientists have generally abandoned the idea that they will identify a singular cause for SIDS, Dr. Ackerman said that by slowly chiseling away at the multitude of SIDS causes, scientists can at least give parents a small piece of clarity and comfort that they might otherwise be missing.

As well as with physical fitness, you must focused on your Kids nutrition and ensures a well balanced combination of protein, calcium, iron and the B vitamins in their diet.

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