Are Head-Shaping Pillows Safe for Babies?

The Food and Drug Administration (FDA) is advising parents not to use head-shaping pillows for babies. In a memo on November 3, 2022, the FDA explains that these pillows, which are marketed to change the shape of a baby’s head or prevent them from developing conditions like flat head syndrome, are not safe.

“The FDA is warning parents that these pillows are not only unnecessary to prevent medical conditions, but that they pose a potential suffocation hazard within the infant’s sleeping environment,” explainsRachel Prete, DO,a pediatrician at Orlando Health Arnold Palmer Hospital for Children.

If you have one of these pillows or are considering purchasing one for your baby, you likely have questions about what this advisory means. Experts say there are safer ways to address conditions that affect a baby's head shape.

What Is an Infant Head-Shaping Pillow?

Head-shaping pillows are small pillows meantfor babies, which have an opening or indentation in the middle. As the FDA describes, some of these pillows don’t have a hole in the center, but are rectangularly shaped. Whatever the case, these pillows are marketed specifically to treat flat head syndrome or other conditions resulting in a misshapen infant head.

None of these pillows have been approved for treating any medical condition.“There is NO evidence to demonstrate that these pillows actually work,” saysSandra McKay, MD,an associate professor of pediatrics with McGovern Medical School at UTHealth Houston and Memorial Hermann Hospital.

Why Head-Shaping Pillows Aren't Safe For Babies

Head-shaping pillows can contribute to an unsafe sleeping environment for infants. Moreover, these pillows can lead to tragic outcomes, such as sudden infant death syndrome (SIDS) and sudden unexpected infant death (SUID), along with infant suffocation.

It’s not just head-shaping pillows that pose a problem, explainsConnie Bartlett, DO,a pediatrician with Providence St. Joseph Hospital in Orange County, California. She says allinfant pillows are a bad idea.

“Babies have poor neck control in the first 12 weeks of life and therefore, are unable to protect airways (nose and mouth),” Dr. Bartlett explains. “So, pillows of any kind while sleeping can increase risks of suffocation and SIDS.”

According to the Academy of American Pediatrics (AAP), there should be no extra items in your infant’s sleeping space, includingblankets安慰,毛绒动物玩具,床垫装饰,toys of any kind, or crib bumpers.

Infants should be put to sleep flat on their backs to prevent SIDS and suffocation. The mattress you use should be specifically made for your crib or bassinet and you should use a fitted sheet. If your baby starts to snooze in a car seat, infant seat, or swing, they should be moved to a bed.

“Infants should sleep in a crib alone, on their back, without any pillows or blankets,” Dr. McKay emphasizes. “If an infant uses a pillow, they could turn their head into the pillow and accidentally suffocate, or it could become an entrapment risk.”

What Should I Do If I Have a Head-Shaping Pillow?

The FDA says if you currently own a head-shaping pillow, you should throw it out. You also shouldn’tdonateit to a friend or to charity. If you have used this product and your child has experienced any type of negative outcome, the FDA recommends filing a report withMedWatch. MedWatch is the FDA’s Safety Information and Adverse Event Reporting System.

How Can I Fix My Baby's Head Shape?

Some of the cranial (head) issues that can affect infants include flat head syndrome (positional plagiocephaly) and craniosynostosis, a more severe condition where the baby’s skull bones fuse together earlier than what is considered normal.

If you suspect your baby has a more serious issue, it’s best to seek a diagnosis and treatment plan from your child's pediatrician, says Dr. McKay. “Check in with their pediatrician if you are worried about your baby’s head shape to ensure it is really just from positioning and not from another underlying cause,” she advises.

It’s also important to understand that when it comes to cranial conditions, most resolve in due time. “Most positional plagiocephaly, or flat head syndrome, resolves on its own without any intervention,” says Dr. Prete. “If a parent continues to have concerns about the shape of their infant’s head, they should speak to their pediatrician for further guidance.”

Still, if you are looking to resolve the issue sooner, you can focus on preventative techniques such as decreasing the time your baby spends in thecar seat, infant chair, and baby swing, as these devices put extra pressure on your baby’s developing head. You can also switch sides of the crib when you put your baby down to sleep so that different parts of their head make contact with the mattress.

The AAP advises parents to increase tummy time for their little ones, which strengthens their neck and core muscles and helps them develop optimally. Tummy time means placing your baby on their belly in a clutter-free area on the floor, such as a carpet or play mat. You can start doing tummy time with your baby in three to five-minute intervals, two to three times a day, and increase from there. Always supervise your baby during tummy time.

Some infants need their cranial issues addressed with more medicalized interventions, especially if the conditions are more advanced. “In moderate to severe cases, a helmet can be prescribed, custom fitted, and worn for a short duration with close monitoring,” says Dr. Bartlett. Other options may include physical therapy or surgery.