Tag Archive for 'death'

CPSC Warning: Stop Using Infant Sleep Positioners Immediately

Photo courtesy CPSC

The CPSC and the FDA came together yesterday to issue a warning to parents and caregivers to stop using infant sleep positioners immediately as two recent deaths underscore concerns about suffocation.

You may remember the recent recall of the Nap Nanny. Well, now the CPSC is issuing a general warning with regard to sleep positioners after reviewing reports of 12 known infant deaths associated with the products which have occurred over the past 13 years. Most of the infants suffocated after rolling from a side to a stomach position. In addition to the 12 reported deaths, the CPSC has received dozens of reports of infants who were placed on their backs or sides in sleep positioners, only to be found later in potentially hazardous positions within or next to the sleep positioners.

The most common types of sleep positioners are:

  • sleeping bolsters, usually a flat or inclined mat with round or triangular cushions on each side of a baby (see Figure 1) and
  • wedge-style positioners, which elevate a baby’s head higher than its body, sometimes by placing the infant in an attached, diaper-like sling (see Figure 2).

With bolster-style positioners, if a baby is placed on its stomach or if a baby rolls from its side to its stomach, his or her mouth and nose can become pressed against a bolster or other parts of the device. Even if placed on its back, a baby may move upward or downward in the positioner, entrapping its face against a bolster or becoming trapped between the positioner and the crib side or bassinet.

A baby placed on a wedge-style positioner can scoot upward so that its head falls off and hangs over the high edge of the positioner, or the baby may scoot or roll down the wedge so that its mouth and nose are pressed into the positioner. 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.

Many of these devices have been marketed with medical claims that they reduce the risk of SIDS by keeping a child on their back, help with food digestion and reflux (GERD), ease colic, and/or prevent flat head syndrome. However, the FDA and the CPSC have stated that there is currently no scientific evidence supporting these claims and they believe that any benefit from using these devices is outweighed by the risk of suffocation.

The FDA, which has jurisdiction over products making medical claims, is now contacting all manufacturers of infant sleep positioners, including those it had previously cleared with medical claims, and requesting that they stop marketing them until they submit scientific data showing that the benefits of their products outweigh the risk of suffocation or other serious harm.  The FDA has also indicated it will be contacting retailers to ask them to stop selling the devices.

The FDA and CPSC warn parents, caregivers, and healthcare professionals to take this warning seriously and follow these recommendations:

(1)    STOP using infant sleep positioners. Using a device to hold an infant in a particular position is dangerous and unnecessary.

(2)    NEVER put pillows, infant sleep positioners, comforters, or quilts under the baby or in the crib.

(3)    ALWAYS place an infant to sleep on his/her back, and not their sides, at night and during nap time.

FDA pediatric expert Susan Cummins, M.D., M.P.H., says, “The safest crib is a bare crib,” and summarizes the above recommendations with the “ABCs of safe sleep—Alone on the Back in a Bare Crib.”

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-Jasmine

Other recent recalls:
Similac Baby Formula Recalled
Nap Nanny® Recall: What you Should Know
CPSC Vote to Issue Safety Standards that will Eliminate Drop-Side Cribs
Massive Crib Recall Announced: What You Should Know
Double Check your Children’s Medicine

To subscribe to recall announcements and product safety alerts from the CPSC, click here.

Related Articles:
Creating a Safe Sleep Environment for Baby
Sudden Infant Death Syndrome (SIDS) – Reducing Your Risk
A Happy Baby is a Well-Rested Baby – Establishing a Bedtime Routine

Sudden Infant Death Syndrome (SIDS) – Reducing Your Risk

Image courtesy LOLGlitters.com

The most tragic thing for any parent has got to be the loss of a child, and how much more devastating and shocking is it when it comes suddenly and unexplained to their healthy young baby. My heart breaks for any parent who has lost a child to SIDS.

One mother, Mary Best, shared her heart-breaking story in the Back to School 2009 issue of Healthy Children, a magazine published by the American Academy of Pediatrics for parents:

On September 12, I took Will for his four-month checkup and first series of immunizations. Will and our pediatrician were like old friends, and after their usual playtime, Dr. Patel bragged that our little guy was fit as a fiddle.

Two nights later, we followed our regular routine — a bath, grooming, pajamas, prayers, goodnight kisses, and bedtime. I checked on him around 11, and he was sleeping soundly on his back. About 3:45 I woke up to check on him again, like I did every night. When I walked into his room, I sensed something was terribly wrong. Through the darkness, I could see he had rolled over and was face down in his crib. To my horror, he was not breathing. I applied CPR, woke my husband, called 911, and continued CPR. But he was gone.

A few hours after this hellish nightmare began, the police, detectives, EMTs, and coroner took my son away. Along with a part of me. More than two years later, I still suffocate from grief and guilt. Nothing in my life will ever hurt as much as losing my son.

As a mother, this story made me cry. As a mother of a 4 1/2 month old, this story also terrifies me.

Each year in the U.S., about 2,300 babies die from SIDS. SIDS is generally defined as the sudden death of an infant under 1 year of age where the cause remains unexplained after a thorough investigation. 90% of SIDS deaths, however, occur before 6 months of age, with most of them between 2 and 4 months. You can bet I will rest easier when my little girl is out of the danger zone. SIDS occurs during an infant’s sleep, be it naptime or nighttime, but occurs most frequently between 10 p.m. and 10 a.m. with the peak time of death around 5 a.m.

While there are many theories floating out there about the potential causes of SIDS, the prevailing theory is that SIDS results from three overlapping factors:

1. Critical developmental period (i.e. baby’s age). Infants who die of SIDS are in a critical stage of development of their immune, cardiovascular, and respiratory systems.

2. A biological vulnerability resulting from genetics and/or environment in the womb. Researchers are focused on the possibility of a brain defect in the part of the brain that is responsible for arousal. It is believed that these children are unable to arouse themselves when exposed to a lack of oxygen or too much carbon dioxide.

3. An outside stressor. An environmental cause such as stomach sleeping or soft bedding.

Across the spectrum of research, there are a number of factors that have been consistently identified as contributing risk factors for SIDS:

  • Stomach sleeping.
  • Sleeping on a soft surface.
  • Maternal smoking during pregnancy. Accounts for over 60% of SIDS cases among smokers and 20% overall.
  • Overheating.
  • Late or no prenatal care.
  • Young maternal age (i.e. <20)
  • Preterm birth and/or low birth weight.
  • Male gender. SIDS is more common in boys by a ratio of about 3 to 2.
  • Babies born during the fall or winter. More SIDS deaths occur in the colder months, likely due to overdressing and as a result overheating.
  • Siblings of a baby who died of SIDS. It is believed this is the result of a genetic connection; however, an alternative theory exists regarding the potential for toxins emitted from crib mattresses as they age. Given that mattresses are often passed down from one sibling to another, this is believed to be another possible explanation. 
  • Race. It is not known why, but SIDS death rates are highest among American Indians, Alaskan natives, and African Americans.

While some risks cannot be controlled, there are some proactive steps we, as parents, can take to reduce the risk of SIDS. The environment inside and outside of the womb have been identified as contributing to a child’s risk.

For expecting parents, consider these recommendations:

1. Get prenatal care early in and throughout your pregnancy.

2. Practice good nutrition throughout pregnancy to reduce risk of premature birth.

3. Do not smoke and avoid repeat exposure to second-hand smoke when you are pregnant.

For those of us who are now parents of infants, on Monday Heather provided a number of tips for creating a safe sleep environment all of which contribute to reduce a baby’s risk of death from SIDS. I do want to reiterate, though, that placing babies to sleep on their backs is the most important step you can take to reduce the risk of SIDS. Between 1992, when the American Academy of Pediatrics issued the recommendation, and 2001, the SIDS rate decreased by 53% consistent with the decline in the stomach sleeping rate. Heather also highlighted the importance of discussing your baby’s sleeping arrangement with your care provider. Many SIDS deaths in childcare have resulted from children being placed in a sleeping position that they are unaccustomed to. According to the AAP, unaccustomed stomach sleeping increases the risk of SIDS by 18 times.

In addition, consider these recommendations:

1. Choose a separate but nearby sleeping environment. The risk of SIDS has been shown to decrease when the baby is in the same room as the mother. The AAP notes that in Scotland and the UK, the recommendation is that the safest place for an infant is in a crib in the parents’ room for the first 6 months of life.

2. Consider offering your baby a pacifier. It is not known why, but the association of pacifier use with reduced SIDS risk is evident. The SIDS task force recommends pacifier use until 1 year and suggests that you should offer it to your baby when placing him or her down for sleep but do not replace it once your baby is asleep.

3. Do not rely on monitors (i.e. respiratory or cardiac) as a strategy to reduce SIDS. There is no evidence that these reduce risk, and they may promote a sense of false security.

4. Improve room ventilation by using a fan while baby sleeps. A recent study has suggested that using a fan in the room where baby sleeps reduces SIDS risk by 72% compared to no fan in the room.

5. Swaddle your young infant. Some studies have shown that while swaddled babies experience shorter and fewer arousals during sleep, swaddled babies sleeping on their backs are at reduced risk for SIDS. Keep baby’s head and face uncovered and once your baby can roll over, stop swaddling and consider a sleep sack.

6. Practice tummy time to strengthen baby’s muscles.

7. Consider purchasing an organic crib mattress.

For more information on SIDS prevention and research:

American Academy of Pediatrics
CJ Foundation for SIDS
American SIDS Institute
National Institute of Child Health and Human Development

Safe sleeping!
-Jasmine




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