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Wedges for infant sleep: risk of suffocation!

The National Food and Drug Administration of the USA (FDA) published a warning in September 2010 for parents to avoid using positioners for their babies’ sleep. The federal office of the USA warns parents not to place sleep positioning products (the so-called wedges) to their babies, because two recent infant deaths present concerns of suffocation from their use.

The FDA with the Consumer Product Safety Commission published this warning after the examination of 12 infant deaths, which were related with these products.

These products are usually pillows, which are placed behind the baby’s back or in order to elevate the baby’s head. Their aim is to hold the baby in a lateral position during sleep. They are usually used for babies under 6 months of age.

In order to reduce the risk of Sudden Infant Death Syndrome (SIDS), the AmericanAcademy of  Pediatrics recommends that infants should be placed on their back during sleep on a hard, flat surface. It also recommends that there should be no soft objects or toys in the crib, as well as loose sheets, and bed linens unattached to the crib.

Despite the multitude of scientific data that show that sleep on the back is the ideal and safest sleep position for infants, in Greece baby sleep in a lateral position with the placement of a pillow is still very prevalent. The deeply seated opinions of parents and the public, in combination with frequently incorrect instructions from health professionals, lead to persistence to this potentially dangerous practice.

Suffocation and other risks

During the last 13 years, the federal government of the USA has received 12 reports for babies who suffocated, which relate to the use of positioners. Most babies died after having turned from their side on their stomach, with their face on the mattress.

In addition, the Safety Commission has accepted tenths of reports for babies who were initially placed on their back or on their side with the help of these products, but were later found in dangerous positions inside or next to the product.

“We are asking parents to seriously take this warning into consideration, and to stop using sleep positioners, in order to ensure safe sleep for the children”, says Inez Tenenbaum, Chairman of the Consumer Product Safety Commission.

Paediatrican Susan Cummins of the FDA says that parents can create a safe sleep environment for their babies, if they leave their cribs free of pillows, teddy bears, bed linen, toys, and wedges.

“The safest baby crib is the empty crib”, she mentions. “Always place your baby to sleep on the back. Alone, back on the mattress of an empty crib”.

Medical assertions

Some manufacturers advertise their products as being useful for the prevention of SIDS, gastroesophageal reflux – during which stomach acid rises in the oesophagus, causing regurgitation – sips – and plagiocephaly, a deformation of  the skull due to pressure on a certain point.

Even though the FDA has approved in the past a series of such products for gastroesophageal reflux and plagiocephaly, more recent data lead to the conclusion that sleep positioners increase the risk of suffocation.

As a result of more recent information, the FDA requests from manufacturers to submit evidence, which show that the benefits of the product exceed the risks from its use. In addition, it demands that manufacturers do not advertise and promote their products until the FDA examines the evidence.

The manufacturers of positioners for infant sleep, who present medical claims without the approval of the FDA, should immediately stop the promotion of their products. According to recent scientific data, there is no evidence to support the medical claims for benefits from the use of these positioners.

Advice to consumers

Stop using products for infants, which place the baby on the side to sleep. The use of these products in order to keep the baby in a lateral position is useless and dangerous.
Never place pillows, wedges, toys, and loose bed linen in the crib or under the child.
Always place your baby with the back on the mattress, at night and during day naps.

More information: www.fda.gov/ForConsumers/ConsumerUpdates

Just in England, from 1991 until today, more than 15 thousand children play happily in the streets instead of having suddenly died from Sudden Infant Death Syndrome, because their parents have implemented the directive for them to sleep as infants with their back on the mattress. This is one of the most successful interventions of public health in history. And yet, 20 years later in Greece, parents and some health professionals continue to believe that babies should be placed in a lateral position with a wedge on their back!

Stelios Papaventsis MRCPCH DCH IBCLC 2010

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