The sleep positioner devices come primarily in two forms. One is a flat
mat with soft bolsters on each side. The other, known as a wedge-style
positioner, looks very similar but has an incline, keeping a child in a very
slight upright position. Makers of the devices claim that by keeping infants in
a specific position as they sleep, they can prevent several conditions,
including acid reflux and flat head syndrome, a deformation caused by pressure
on one part of the skull. Many are also marketed to parents as a way to help
reduce a child’s risk of sudden infant death syndrome, or SIDS, which kills
thousands of babies every year, most between the ages of 2 months and 4 months.
But the devices have never been shown in studies to prevent SIDS, and
they may actually raise the likelihood of sudden infant death, officials say.
One of the leading risk factors for sudden infant death is placing a baby on
his or her stomach at bedtime, and health officials have routinely warned
parents to lay babies on their backs. They even initiated a “Back to Sleep”
campaign in the 1990s, which led to a sharp reduction in sudden infant deaths.
With the positioner devices, if an infant rolls onto the stomach, the
child’s mouth and nose can press up against a bolster or some other part of the
device, leading to suffocation. Even if placed on the back, a child can move up
or down in the positioner, “entrapping its face against a bolster or becoming
trapped between the positioner and the crib side,” Gail Gantt, a nurse consultant
with the Food and Drug Administration, said in an e-mail. Or the child might
scoot down the wedge in a way that causes the child’s mouth and nose to press
into the device. “The baby’s movement may also cause the positioner to flip on
top of the baby, trapping the baby underneath the positioner or between the
positioner and the side of the crib,” she said.
Of the 13 babies known to have suffocated in a sleep positioner since
1997, most died after they rolled from their sides onto their stomachs. The
Consumer Product Safety Commission has also received dozens of reports of
babies who were placed on their sides or backs, “only to be found later in
hazardous positions within or next to the product,” the F.D.A. said in a
statement. Many baby books for new parents specifically urge against using
sleep positioners, and the American Academy of Pediatrics does not support
their use for SIDS prevention. Though the F.D.A. has never approved the
positioners for the prevention of SIDS, it has in the past approved a number of
the devices for the prevention of gastroesophageal reflux disease and flat head
syndrome. But the agency said that in light of the new safety data, it believed
any benefits from using the devices were outweighed by the risk of suffocation.
As of Wednesday (Nov. 21), the agency is explicitly advising parents to
stop using sleep positioners, and it has asked manufacturers of the devices to
submit clinical data showing that the benefits of their products outweigh the
risk of serious harm. In addition to avoiding the devices, experts say, parents
should keep things like pillows, comforters, quilts and bumpers away from their
infants and their cribs. Soft bedding can increase the likelihood of a baby
suffocating. “The safest crib is a bare crib,” Dr. Susan Cummins, a pediatric
expect with the F.D.A., said in a statement. “Always put your baby on his or her back to sleep. An easy way
to remember this is to follow the ABC’s of safe sleep – Alone on the Back in a
bare Crib.”
Source: NY Times
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