Parents and caregivers should not use pillows to change the shape of a child’s head or to treat a medical condition, the U.S. Food and Drug Administration said Thursday.
“The use of head-shaping pillows can create an unsafe sleep environment for infants and pose a risk of suffocation and death,” the FDA said in a news release.
The FDA’s statement clarifies that pillows created to cradle a baby’s head while sleeping on their back “with a notch or hole in the middle” are not FDA-approved.
“FDA has no proven benefit from using infant head shaping pillows for any medical purpose,” the agency said in a statement. “Using head-shaping pillows can create an unsafe sleep environment for children and put them at risk of suffocation and death.”
Baby head-shaping pillows are intended to treat or prevent flat head syndrome, or plagiocephaly, a common problem for babies who spend a lot of time sleeping on their backs, says the UK’s National Health Service.
The FDA news release explains that flat head syndrome usually goes away on its own, is not painful for children, and does not cause developmental concerns.
“If you have a pillow to shape the child’s head, throw it away; do not give it or give it to anyone else,” the agency said.
For healthcare providers, the FDA recommends that they discourage the use of infant head-shaping pillows and ensure that patients understand the risk of infant death with their use. The FDA recommends that healthcare providers promote awareness of safe sleep environments and educate patients about safe treatments for flat head syndrome.
If parents notice an unusual head shape in their child, they should consult a health care provider. Helmets, headbands, and caps are FDA-cleared options that healthcare providers can offer to treat flat head syndrome.
According to the FDA, the use of infant head-shaping pillows can delay necessary evaluation and treatment, not only for flat head syndrome, but also for more serious conditions, such as craniosynostosis, where the bones of a developing baby’s skull fuse together too early.
Baby head-shaping pillows are readily available and can be found at many large baby stores, according to Dr. Sarah Schaffer, a pediatrician at Nationwide Children’s Hospital.
“We hope this recommendation will lead to the removal of these websites,” Schaffer said.
“Sudden Unexpected Infant Death (SUID), which includes Sudden Infant Death Syndrome (SIDS), is the leading cause of childhood injury death,” the American Academy of Pediatrics said on its website. “Sleep is a big challenge for families with babies, but following safe sleep recommendations can prevent many SUID deaths.”
To create a safe sleeping environment, babies should sleep on their backs on a portable blanket on a firm, level sleeping surface, according to the National Institutes of Health. There should be no toys, blankets or other items in the sleeping area.
“Don’t use any headgear or headgear with your baby gear that didn’t come in the box,” Schaffer said, adding that car seat attachments aren’t safe either.