We’ve made significant strides since the days of the “Radio Nurse.”
In 1937, the first electronic baby monitor emerged, allowing parents to listen to their baby’s nursery from another room.
Fast forward nearly a century, and the focus has shifted from mere listening to comprehensive monitoring. Recently, a surge of high-tech baby wearables has arrived, tracking everything from sleep habits to oxygen levels.
The sales pitch is straightforward. If adults are eager to use health trackers like Fitbit or Oura Ring, why not extend similar insights to infants?
Take Nanit’s breathing wear collection. It includes swaddles, pajamas, and sleeping bags that monitor a baby’s breathing by tracking movement, alerting parents via an app if nothing is detected.
Then there’s the Snuza Hero. You attach it to your baby’s diaper while they sleep, and if it doesn’t detect breathing for 15 seconds, it vibrates gently to wake them. If still no movement after 20 seconds, an alarm sounds.
Also, consider the Sense-U Smart Baby Monitor. This device keeps tabs on abdominal movements, rollovers, and body temperature, sending real-time alerts to a smartphone app. It vibrates and alarms when necessary.
The list is extensive, and regulators are still catching up. In September, the FDA issued a warning, urging parents and healthcare providers to avoid using devices that claim to monitor infants’ vital signs without federal approval.
While specific products weren’t mentioned, the warning applies to many on the market, despite some gaining approval overseas or being backed by independent studies.
In the U.S., many wearable devices are categorized as general health products, not medical devices, which allows them to be sold without FDA approval, bypassing formal reviews.
Though these devices show promise, their safety and effectiveness have yet to be evaluated by the FDA.
Manufacturers of products like Nanit Breathing Wear, Snuza Hero, and Sense-U all emphasize that their devices aren’t medical tools meant to diagnose or treat conditions such as Sudden Infant Death Syndrome (SIDS). Most also caution that their devices may yield false readings.
No companies responded to requests for comments.
However, the concept of a “smart” baby isn’t far-fetched. Several infant wearables on the market have received FDA approval, like the Owlet Dream Socks.
Set to retail for $299.99, the device wraps around the baby’s foot and is intended for infants aged 1 month to 18 months.
“We utilize the same pulse oximetry technology found in hospitals to continuously monitor pulse rate and oxygen saturation, along with sleep position and movement,” Liz Teran, Owlet’s chief parent officer, mentioned.
Parents receive immediate alerts if pulse rates or oxygen levels stray from set parameters. The Dream Sock is FDA cleared for safety and effectiveness on all skin tones.
Additionally, the accompanying app analyzes sleep and wake data, helping predict when a baby might show signs of sleepiness, aiding parents in managing schedules and reducing fatigue.
Teran pointed out that real-time health data can alleviate parental anxiety and could benefit visits to pediatricians.
“Transitioning from merely intuition to data-backed decisions fundamentally changes interactions between caregivers and healthcare teams,” she explained.
She shared an example of a mother who, receiving alerts about her baby’s declining oxygen levels overnight, revisited the pediatrician, who had initially downplayed her concerns. This ultimately led to confirming a heart condition through tests.
Nevertheless, some doctors and experts raise concerns that these wearables could undermine safe sleep practices. A false sense of security might tempt caregivers to overlook established safety guidelines.
There’s an ongoing worry about false or unnecessary alarms, potentially leading to additional stress. Such situations could cause anxiety, sleep disturbances, or unnecessary medical tests for the baby.
“Alarm fatigue is a serious topic in the medical community, especially in hospitals where alarms can be incessant. Parents might experience this at home too,” said Dr. Joanna Parga Belinki, a neonatologist at Children’s Hospital of Philadelphia.
“My concern is for parents who feel they must use one of these devices. While they are marketed as enhancing a baby’s health, there’s no concrete data to support this claim,” she added.
Regarding the Dream Sock, Teran noted it has a “very low false alarm rate,” but factors such as fit and Bluetooth range can affect this.
Regardless of concerns, Teran believes infant wearables could one day become as common as traditional monitors and strollers.
“Video or audio monitors have been embraced by parents for many years, but today’s parents seek more insight. They want to understand the data regarding their baby’s health and sleep so they can act confidently in the moment,” she shared.
Teran suggested that the implications could extend beyond infancy.
“Creating a health baseline from day one can lead to a comprehensive record that informs a child’s care well past infancy,” she concluded. “Early data like this might shape health outcomes in ways we are beginning to realize.”
