WEDNESDAY, Oct. 4, 2017 -- Infants should be put to sleep on their backs on a firm, empty surface and never placed on a sleep positioner, the U.S. Food and Drug Administration says.
The agency warned parents and caregivers that these products, also known as "nests" or "anti-roll" supports, can prevent babies from breathing.
The two most common sleep positioners include two raised pillows or "bolsters" attached to a mat. Babies younger than 6 months old are placed on the mat between the pillows to keep them in a specific position while they are sleeping.
But putting babies to sleep on or near soft objects, such as positioners, toys, pillows and loose bedding, increases the risk for accidental suffocation and Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics says.
Some babies have been found in dangerous positions next to a positioner they had been placed in for sleeping. Federal officials also reported that infants have died after being placed in one of these products. In most cases, the infants got out of position, rolled onto their stomachs and suffocated, the FDA explained.
The agency urged parents and caregivers to always put babies on their back for naps and when they go to sleep at night.
Babies should never sleep with a positioner, pillow, blanket, sheets, a comforter or a quilt, the FDA advised.
Infants' sleeping surfaces should be bare and free of any loose items. Appropriate clothing keeps babies warm enough while they are sleeping.
The FDA regulates baby products that claim to cure, treat, prevent or reduce a disease or condition. Some sleep positioner companies claim that their products prevent SIDS. But the FDA noted it has never cleared an infant sleep positioner that promises to prevent or reduce the risk of SIDS since there is no scientific evidence to back up this claim.
Some companies market their products as helpful for easing gastroesophageal reflux disease (GERD), a condition that causes stomach acids to back up into the esophagus. Others suggest their positioners help prevent flat head syndrome (plagiocephaly), a deformation caused by pressure on one part of the skull.
But while some products were previously approved for GERD and flat head syndrome, the FDA asked these companies to stop marketing these items since the risks associated with their use outweighed any possible benefits.
Every year about 4,000 infants die unexpectedly while sleeping due to suffocation, SIDS or another unknown cause, according to the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
The FDA urged parents and caregivers to talk to their child's doctor if they have questions about putting babies to sleep safely.
The American Academy of Pediatrics provides more information on infant sleep safety.
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