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For years, sleep-deprived parents have been inundated with ads for infant sleep products that promised improved sleep for babies, less fussiness and success in “easing the transition from the womb to the world.” Many of these products are available in stores and online despite concerns from pediatricians that they are unsafe for infants. Now, a flurry of national efforts aims to raise awareness of the risks posed by some of these items, and to crack down on potentially dangerous products.

Last week, the American Academy of Pediatrics (AAP) released updated safe sleep recommendations, which, for the first time, discourage using products like weighted swaddles and weighted sleep sacks, as well as home cardiorespiratory monitors. These products have grown in popularity since the AAP last published recommendations in 2016. The organization also encourages parents to put babies to sleep on a flat, non-inclined sleep surface, a nod to the popularity of the inclined sleepers that have led to at least 94 deaths over the past 10 years. The guidelines also repeat previous advice that infants should sleep in the same room — but not the same bed — as their caregivers.

The updated recommendations closely follow a new federal law that bans the sale of crib bumpers and infant sleepers with an incline greater than 10 degrees, new federal standards for infant sleep products set by the Consumer Product Safety Commission (CPSC), which went into effect last week, and a new safety commission standard for crib mattresses and play yards, which goes into effect this fall.

Pediatricians and parents who advocate for safe sleep hope these efforts will give parents more guidance and make sure that products are as safe as possible for babies, especially in a market where some infant items are unregulated or have slipped through regulatory cracks. Each year, around 3,500 infants die in their sleep from causes that include sudden infant death syndrome (SIDS), accidental suffocation and strangulation.

Parents may believe that infant sleep products are heavily regulated by federal agencies and must pass stringent safety tests before they can be sold. But that hasn’t been the case. Products that don’t fall into categories that have long been regulated, like cribs or bassinets, have been allowed to go to market without such safety rules. (Other regulations, related to additional safety aspects of a product, such as a material’s flammability, lead content and product labeling, may apply.)

“There are some loopholes in the system,” said Dr. Michael Goodstein, the division chief of newborn medicine at WellSpan Health and adjunct professor of pediatrics at Pennsylvania State University. “When you create a unique product, it’s like, there’s just no oversight to it until standards are developed,” he said. “And a lot of times we don’t find out there’s a problem until after the fact.” In contrast, manufacturers of other products, like medication, must prove safety before the item can be sold, he added.

The Fisher-Price Rock ‘N Play, for example, was sold without undergoing medical safety tests. It was later recalled in 2019 after a Consumer Reports investigation found dozens of infants died in the sleeper, which featured a 30 degree incline.

Babies should be put to sleep on their backs on flat, non-inclined surfaces, without loose blankets, and should be separate from their caregivers, according to updated safe sleep recommendations from the American Academy of Pediatrics. Credit: Daniela Jovanovska-Hristovska/Getty Images

Pediatricians say some manufacturers of infant products may claim their products are safe for sleep but that evidence doesn’t always hold up under scrutiny. Dreamland Baby Co., which makes weighted blankets and sleep sacks, points to multiple studies about toddlers and adults using weighted blankets on a web page about the product’s safety for infants. The company also includes one infant study as evidence of its products’ safety. But some pediatricians and safe sleep advocates say that study, which looked at just 16 newborns with Neonatal Abstinence Syndrome who used a weighted blanket for 30 minutes while being monitored in a hospital, doesn’t necessarily prove weighted sleep sacks are safe for unattended overnight sleep at home.

“There’s absolutely no data whatsoever, zero, to support the use of weighted sleep sacks” in a home environment, said Goodstein. “People translate what works for adults and kids into, ‘If it’s good for us, it must be great for babies too,’” he added. “Babies are not little adults. They’re babies. They’re completely different with different physiology and different needs.”

In a statement provided to The Hechinger Report, Tara Williams, founder of Dreamland Baby, said the company is partnering with a university to conduct a clinical study on the safety of weighted sleep products in a “non clinical sleep environment.” She encouraged parents and caregivers to read the new safe sleep recommendations, but said she has “complete confidence in the efficacy and safety of our products.”

Laura Hegstrom, a mother of two who lives in Colorado, assumed the weighted sleep sack her daughter slept in for several months as an infant was safe because it was marketed for babies and was allowed on the shelves of multiple stores. It was “eye opening” when she learned, several years later while pregnant with her second child, that many pediatricians think weighted sleep sacks could be dangerous: The added weight might cause babies to overheat or trap them in an unsafe position on their stomachs where they could then suffocate. She vowed to do more research into safe sleep before her second child’s birth.

It was not the only potentially unsafe product her family had used. Hegstrom’s daughter had napped in the now-recalled Fisher-Price Rock ‘N Play as an infant; the family’s pediatrician had warned Hegstrom the product was unsafe when she mentioned it at an appointment.

“We just made a lot of little mistakes,” Hegstrom said. “We’re really grateful they didn’t have consequences but looking back now, it just gives me so much anxiety thinking about it.”

Some parents have reported concerns with weighted sleep products in online product reviews and formal channels. On a federal website that collects consumer complaints, one parent said the weighted portion of a sleep sack created by Nested Bean bunched up around her 3-month-old’s neck, “causing a serious potential for asphyxiation.” Nested Bean did not respond to requests for comment.

“The recommendation against weighted swaddles and sleep sacks specifically is due to concerns that the weight on the chest can constrict chest movement and that the weight can both help infants get into and then be unable to get out of unsafe sleep positions,” said Dr. Rebecca Carlin, an assistant professor of pediatrics at Columbia University, pediatric hospitalist and one of the authors of the new AAP recommendations, in an email interview. “While I am certainly sympathetic to the desire to calm and soothe infants, anything that makes it harder for an infant to breathe or potentially suppresses an infant’s drive to breathe is not recommended.”

Getting unsafe products off the shelves will help make sleep environments safer, experts say, but parents and caregivers also need to learn more about how to keep sleeping infants safe and why the AAP cautions against certain products and environments. While some parents may know about safe sleep but choose not to follow recommendations for various reasons, others may have no idea their baby’s sleep arrangement is unsafe.

Katie Getz, a parent who used to run a California child care center, said most of her safe sleep information came from research she did on her own. “The information is out there, but it wasn’t as easily accessible as I thought,” Getz said. “I kind of stumbled upon it on Facebook … nobody really talked about safe sleep.” While she learned about some unsafe sleep environments, like swings, while working in child care, she said there was a lot she didn’t know when she became a parent almost three years ago. She said parents should be provided more education during prenatal care appointments, at hospitals, or even on billboards, to make sure the information is “more available and more normalized.”

While some parents do receive safe sleep information in the hospital, many do not. And the information they do get may be inadequate, parents say.

A 2015 survey in Nebraska found that hospitals do not provide “consistent messaging” about safe sleep, and patient education materials and processes vary. A 2019 study, using data from an earlier survey, found that between two and nine months postpartum a majority of mothers nationwide had received advice from a health care provider on various safe sleep practices, but the topics covered by providers varied. Pediatricians and other health care workers can make a difference: The study also found parents were more likely to follow recommended practices if they were instructed on safe sleep.

Michelle Barry, a mother of two, said she hadn’t been taught anything about safe sleep when she gave birth to her first child in Connecticut in 2017. And what she learned in the hospital was cursory. Before going home, she said she was handed a checklist about safe sleep and told to read it and sign it, acknowledging she understood. Her son ended up sleeping in a now-recalled Fisher-Price Rock ‘N Play. Barry founded a safe sleep nonprofit in 2020, based on a safe sleep support group on Facebook. Much of her work now focuses on sharing evidence-based safe sleep information with other caregivers on social media. (Barry is also leading a committee to develop regulations for wearable infant blankets with ASTM International, an organization that develops voluntary standards for products that countries can use as part of formal safety regulations.)

In recent years, states like South Carolina and Maine have tried to expand the information and training hospitals offer to new parents. One program tried to address safe sleep by texting information to new parents when they are home with their infants and may not be adhering to safe sleep guidelines.

Parents and pediatricians say better education could save lives. Carlin, the Columbia pediatrician, said there is “a lot of work” that can be done to improve safe sleep education, and make sure it is “respectful, nonjudgmental and culturally appropriate.” It should occur in a variety of settings before an infant is born, she said, and, if possible, involve messaging safe sleep practices to all caretakers and family members, so the habit of putting infants to sleep on their backs without loose blankets becomes ingrained.

When new parents are exhausted and overwhelmed in the hospital or at initial prenatal visits, it can be hard for them to absorb all of the education provided,” Carlin said. “However, if we can create positive attitudes around safe sleep practices and provide education during pregnancy, parents are more likely plan to use these practices.”

Hegstrom said she feels angry and sick when she looks back at the unsafe products she bought and used with her first child. “I felt like I had failed by putting her in something that was potentially deadly, even though there was no reasonable way of me knowing,” she said. She destroyed her Rock ‘N Play and weighted swaddle after learning they were unsafe, to make sure nobody else would use them. Her second child, a 1-year-old, now sleeps in a non-weighted sleep sack in a portable crib in her bedroom. She said it concerns her that she didn’t know more about safe sleep even though she had a considerable amount of support and resources at her disposal. “It makes me really worried about moms and dads who don’t have those sort of resources and education, and just are unknowingly using these products,” she said.

This story about infant sleep products was produced by The Hechinger Report, a nonprofit, independent news organization focused on inequality and innovation in education. Sign up for Hechinger’s newsletter.

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