Safe Sleep is an investigative series examining what risk factors were present in more than 1,300 incidents of infant death over an 11-year span in Canada.
When Jodie Nazvesky’s son, Sterling, was born 18 months ago, he wasn’t breathing.
Although he began drawing breath shortly afterward, in the days that followed, he had two apneas — incidents when breathing temporarily stops.
He was discharged from the neonatal intensive care unit at the IWK Health Centre in Halifax four days after he was born, but it took a long time for Nazvesky to let go of the fear of another apnea episode.
She had another worry, too.
“I was very anxious when it came to SIDS because I had consumed so much stuff online. I knew too much about that and the risks.”
To help ease her concern about sudden infant death syndrome, or SIDS, a relative gave her a baby monitor that tracks an infant’s oxygen level and heart rate and sends an alert to a caregiver’s wireless device if either falls outside an acceptable range.
The Owlet Smart Sock “offered incredible peace of mind,” Nazvesky said. “I don’t think we would have slept without it.”
Parents today can choose from a wide variety of options ranging from simple audio monitors to those that track breathing, heart rate, oxygen, skin temperature and sleeping position and promise to notify parents if something goes awry, such as if the baby’s nose and mouth are covered or if the baby rolls over.
Others even vibrate to rouse a baby if they don’t detect breathing for a certain number of seconds.
Some monitors can also measure air temperature and humidity, play lullabies, take photos and record data about how many hours a baby has slept.
More and more parents are choosing these smart monitors despite their cost, which can exceed $500. According to ResearchandMarkets.com, a market research company, the global market for smart baby monitors is expected to grow from nearly $1 billion US in 2020 to $1.8 billion US by 2028, driven in part by increasing concerns for child safety.
Questions about accuracy
But guidance from the federal government, the Canadian Paediatric Society and Baby’s Breath Canada — a foundation focusing on SIDS and sudden and unexpected infant deaths — cautions caregivers about using home cardiorespiratory monitors for babies, saying there is no evidence they reduce the incidence of SIDS and can provide a false sense of reassurance.
A 2017 study by researchers who were all paid by Owlet touted the Smart Sock’s success, saying that out of 47,495 newborns using the product, Owlet had received more than 80 reports from parents that it helped prevent a critical incident or diagnose an overlooked condition, including the common respiratory virus RSV, erratic heartbeat, breathing disturbance, obstructed airway caused by unsafe sleep practices, congenital heart defect and apnea.
Of those, 49 appeared clinically significant and were verified by a health-care provider, the study said.
But a 2018 study of 30 infants at the Children’s Hospital of Philadelphia comparing the accuracy of two consumer monitors — the Owlet Smart Sock and Baby Vida — to a reference monitor “revealed concerning findings.” The Owlet was found to “perform inconsistently” and the Baby Vida didn’t detect low blood-oxygen levels and also reported false low pulse rates.
The lead author of that study, Dr. Christopher Bonafide, also published a 2017 article in the Journal of the American Medical Association concluding “until they have been thoroughly evaluated and guidelines for use established, the recommendations physicians should give to parents who ask about these products is simple. There is no evidence that consumer infant physiologic monitors are life-saving and there is potential for harm if parents choose to use them.”
Monitors can increase anxiety
Such products can sometimes heighten parental anxiety about their infant’s well-being, said Jennifer Doering, an associate dean in the college of nursing at the University of Wisconsin – Milwaukee.
“It increases the risk of parents getting post-traumatic stress,” said Doering, who has studied infant safe sleep and postpartum sleep disruption and fatigue.
“If you’re … woken up in the night by an alarm going off and you think your baby is dying and then you have that experience over and over and over again in your home, how are you going to trust that your baby is going to be OK?”
Alanna Stockley of Middle Sackville, N.S., thought her smart monitor would help her feel more at ease when her son Charlie was born 2½ years ago.
“Sudden infant death syndrome is terrifying, of course, and we thought that anything that could help us prevent that or not have to go through that experience was going to be something that we were going to do.”
But the monitor, which tracked the baby’s breathing, exacerbated Stockley’s postpartum feelings of anxiety.
“I felt overwhelmed. It felt like there was just too much information, and I could not settle my mind when we were using it. It was just constant worry that something was going to go wrong and I wasn’t going to be notified.”
At the suggestion of an IWK Health Centre counsellor, Stockley stopped using the breathing monitor after just a few weeks, relying instead on a video monitor. She said after that, she wasn’t constantly on edge, listening for alarms on the monitor.
Smart monitors are “incredibly popular” and highly recommended by parents in online groups — particularly to ease concern about infant death, said Kelly Pretorius, a pediatric nurse practitioner who analyzed mothers’ social media posts about SIDS as part of her PhD research at the University of Texas.
“Most mothers are saying, you’ll be OK, you just need to buy this. This product will help appease this,” she said.
But Pretorius said for some parents, using a monitor can be like “putting a Band-Aid over a lot of other issues,” and lead to serious diagnoses like postpartum anxiety being overlooked.
Unsafe sleep practices
Pretorius saw evidence in her study that some mothers may be influenced by the monitors to choose unsafe sleep practices for babies because they feel they have reassurance from the product.
The 2020 study, published in the Journal of Medical Internet Research, analyzed 912 comments about SIDS in a Facebook group for mothers.
Pretorius cited one example of a mother who noticed that her weeks-old daughter had “the best nap ever” when she fell asleep during tummy time one day, so “I got the Owlet immediately so I could then get some sleep at night.”
The guidelines say parents should prioritize safe sleep practices, such as placing a baby to sleep on their back, alone, in a crib or bassinet free from sleep items or clutter, in the same room as the caregiver.
None currently licensed
In Canada, smart baby monitors that track breathing, heart rate or oxygen levels are regulated as Class II medical devices — the second-lowest of four tiers of risk to health and safety.
But there are no at-home cardiorespiratory monitors for babies currently licensed as medical devices, and in the last five years, Health Canada has received six complaints about baby monitors being sold without a medical device licence.
Health Canada does not routinely review their safety and effectiveness before they are licensed, but manufacturers are required to have evidence showing that their product is safe and effective.
The U.S. Food and Drug Administration has received three reports about problems or adverse events associated with Owlet products, including that they malfunctioned or caused a burn or blister on a baby’s foot.
Nazvesky said her son’s foot also appeared to be burned or blistered after using the Owlet Smart Sock, but he never seemed hurt or bothered by it, although he still has a small scar from it.
“I’ve no idea what it was, but it 100 per cent looked like a burn,” she said.
In a statement to the CBC, Owlet said the safety and accuracy of the Smart Sock have been tested and validated, and that the sock products “have been worn by babies for hundreds of millions of hours. We are confident in the safety of our products.”
Health Canada, FDA concerned
Both Health Canada and the U.S. Food and Drug Administration have in recent months ordered Owlet to stop selling and advertising its Smart Sock until the company obtains a medical device licence for the product.
Although a disclaimer on Owlet’s website says the product does not “diagnose, cure, treat, alleviate or prevent any disease or health condition,” the FDA said the company’s marketing suggests otherwise.
Most smart baby monitors contain some version of this disclaimer, specifically mentioning the products’ inability to diagnose or prevent SIDS.
An FDA spokesperson told the CBC it could not disclose whether the agency was investigating other baby monitor products.