Can tech really solve SIDS? It's not so simple

How flawed data and a sensitive subject might be leading us to the wrong conclusions about wearable baby monitors

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When wearable baby monitors burst onto the scene in 2014, few predicted how successful they'd become. Since then, devices like Snuza, MonBaby, Owlet and Mimo have become common baby shower gifts and early parent purchases, with hundreds of thousands of units collectively sold in the US and around the world, according to their developers.
Their proliferation makes sense: Sudden Infant Death Syndrome, or SIDS, and other health crises like it are the nightmares of countless new parents. The $120-$250 price tags on monitors seem reasonable, if the gadgets will avert such disasters.
But many in the media and medical community remain dubious. One 2014 British Medical Journal article proclaimed, "No evidence shows that [wearable baby monitors] reduce the risk of SIDS or have any other health benefits." Developers sidestepped such critiques, claiming their devices offer parents "reassurance."
As a new dad and baby-tech reviewer, I decided to do my own research. I quickly discovered the wearable baby monitor market contains a series of contradictions that converge in one basic truth: No one can say whether wearable baby monitors are worthwhile, because no one can prove that they help or that they don't.

The first contradiction: Monitors work...and don't

The efficacy of wearable baby monitors depends on two questions. First, will the monitor accurately track what it claims to track? Second, will such tracking improve health outcomes for children?
I've personally tested the first question with MonBaby, Owlet and Snuza, at least anecdotally verifying their ability to track a child's breathing accurately. Problem is, no one's been able to answer the second question. Does monitoring make any difference when it comes to SIDS or other medical crises?
There's a reason multiple monitors say they can't "detect or prevent causes" of SIDS or other conditions in their disclaimers.
"The US is extremely litigious," explained a Snuza representative. "We need to tread carefully."

Snuza Hero SE uses a contact sensor in its rubber tip to track the breathing movements of the baby. If the movements stop for fifteen seconds, the monitor vibrates to rouse the child. After twenty seconds, a loud alarm sounds. Chris Monroe/CNET

To be labeled a medical device in the United States requires certification through the US Food and Drug Administration. While that process happens mostly behind closed doors, the government entity considers "how the product is labeled, promoted or used," a representative at the FDA explained.
That means monitors can't hide behind veiled language about "keeping baby safe." So far, no baby monitor has earned the certification necessary to be considered a medical device. In order to gain that, they have to demonstrate some "intended...use in the diagnosis of a disease or condition, ... [or] in the cure, mitigation, treatment, or prevention of disease," according to the FDA.
Essentially, there's a gap between the claim that monitoring works, and that it helps.

Owlet uses pulse oximetry to measure oxygen levels in the bloodstream. While it is more expensive than many competitors, the technology at its foundation makes it more likely to successfully seek FDA certification.

The second contradiction: The research exists...and doesn't

Remember that 2014 BMJ article? It references three clinical studies to show monitors make no impact on SIDS rates in children. They are dated from 1986, 1988 and 2001.
The American Academy for Pediatrics references these same three studies when it makes this rather strong recommendation: "Do not use home cardiorespiratory monitors as a strategy to reduce the risk of SIDS."
There are multiple problems with the referenced data, though, not least of which is its age. The first two studies took place about three decades ago. They even included instances of children dying due to misuse of those early monitors, said Michael Goodstein, a member of the AAP Section on Neonatal-Perinatal Medicine and a professor at Penn State University. That's practically unthinkable with today's monitors.

MonBaby functions both as a breathing monitor, and as a position monitor. If a child flips onto their belly while sleeping (a risk factor for SIDS), the monitor will alert parents.

Additionally, the most recent research hasn't examined enough instances of SIDS to offer statistically significant insight into whether or not monitors affect its outcome. The 2001 study referenced both by the AAP and the BMJ included over 1000 participants, but witnessed the death of only six children. This past data should leave us with, at worst, an agnostic view of devices today.

Developers of wearable baby monitors have even less compelling evidence to convince us of their efficacy. They rely on parent testimony.
Early in Owlet's product life, founder Jordan Monroe posted the story of three children whose parents had been alerted to low oxygen levels. "Two of the children were turning blue when their mothers picked them up and stimulated them to start breathing again."
Publications reporting on Monroe's blog post failed to acknowledge the major shortcomings of anecdotal evidence of this sort. In short, there's no way to know if the children would've recovered independently (as often happened in the 2001 study).
The inability of developers to overturn the medical community's agnostic stance toward monitors raises important questions about consumers' readiness to adopt unproven technology. But research on both sides also suggests something more fundamental: that SIDS itself is exceptionally difficult to understand.

SIDS, as a diagnosis of exclusion, is very different from other medical diagnoses. There aren't clear causes or fool-proof methods of prevention -- only broad trends and best practices. 

The third contradiction: We understand SIDS...and don't

"Sudden infant death syndrome (SIDS)," according to the Mayo Clinic, "Is the unexplained death, usually during sleep, of a seemingly healthy baby less than a year old."
Seems like a simple definition, right? Not when you look closely. SIDS is what's called a diagnosis of exclusion, meaning it is a diagnosis applied only after every other potential explanation has been ruled out. That makes it impossible to prescribe treatment or attribute cause.
The medical community has discovered many large-scale trends around SIDS. Children are more likely to die from SIDS if they sleep on their bellies, live in a home with a smoker, co-sleep in the same bed with parents or siblings, or are premature. The list goes on. Educating the public about such trends has dropped SIDS rates to an historic low of about 1 death per 2000 live births, where it has remained relatively consistent for the last fifteen years.
As the rates dropped, SIDS grew more difficult and more expensive to study. To get numbers of any real statistical value, researchers would have to include tens of thousands of participants, and record enough instances of SIDS to compare monitored outcomes with non-monitored outcomes.
Wearable monitor companies appear to be in a bind. The "no empirical evidence" criticism is still valid, but companies have no real recourse.

Practices like laying children on their backs and not using blankets have led to lower instances of sudden unexpected infant death in the past twenty years. 

The fourth contradiction: People trust monitors...and don't

George Little, doctor and chairman of the 1986 National Institutes of Health consensus board, spearheaded a review of the research regarding monitors in the 1980s. Interviewed in the book "The Death of Innocents: A True Story of Murder, Medicine, and High-Stakes Science," Little saw fundamental divides in the national conversation.
"You're dealing with an entity where kids die," he said to authors Richard Firstman and Jamie Talan. "Now, when you die, you stop breathing and your heart stops. So there's an intuitive thing that says, well, if you have a gizmo that tells you how fast you're breathing, or how fast your heart is going, then maybe you can prevent death."
Although Little concluded that the data from those early monitors couldn't confirm that intuition, he did discover something else: "There is a huge industry here...that has been entrepreneurial as hell. They're getting your attention...[telling you] there must be a black box that can tell us when a baby's going to die."
Little touched on something important: every party is deeply invested. Parents want to keep their children safe. Companies want to profit. Medical professionals, in the face of ambiguous data, adopt a "do no harm" policy. At the end of the day, many parents disregard the data and disclaimers because they want the monitors to help.
All of this leaves us in a difficult position. The lack of empirical evidence leads journalists and doctors to doubt these devices, but that hasn't stopped parents from buying them or companies from selling them.
Uncomfortable as it may be, this situation is unlikely to change anytime soon.

news source by; CNET