Officials Warn Against Baby Sleep Positioners
January 02, 2013
Health officials are
warning parents not to use a special device designed to help keep babies
in certain positions as they sleep. The device, called a sleep
positioner, has been linked to at least 13 deaths in the last 15 years,
officials with two federal agencies said on Wednesday.
"We urge parents and caregivers to take our warning seriously and stop using these sleep positioners," Inez Tenenbaum, the chairman of the Consumer Product Safety Commission, said in a statement.
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, 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."
"We urge parents and caregivers to take our warning seriously and stop using these sleep positioners," Inez Tenenbaum, the chairman of the Consumer Product Safety Commission, said in a statement.
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, 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."
請扔掉嬰兒防側睡枕
報道 2013年01月02日
美國衛生部官員警告各位家長，不要使用為保持嬰兒特定睡姿而設計的專門器械。兩名聯邦機構的官員於11月21日報告說，該器械稱為防側睡枕(sleep positioner)，在過去的15年內已導致了至少13名嬰兒的死亡。
“我們敦促家長和護理人員認真對待我們的警示，不要再使用此類防側睡枕。”美國消費品安全委員會(Consumer Product Safety Commission)主席伊涅絲·特南鮑姆(Inez Tenenbaum)在聲明中說。
防側睡器械主要分為兩種。一種為水平墊，兩側有柔軟長枕；另一種為楔形，看起來與前一種很類似，只是略有傾斜，能讓嬰兒保持稍稍直立的睡姿。
防側睡枕的製造商宣稱，讓嬰兒保持特定睡姿可以避免諸多問題，包括胃食道返流和扁頭綜合征——頭骨一部分受壓導致的頭部變形。許多製造商還向家長們 宣傳，防側睡枕可以幫助降低嬰兒猝死綜合症（SIDS: sudden infant death syndrome，每年有數以千計的嬰兒因此死亡，以2-4個月大的嬰兒居多）的風險。
然而，從沒有任何研究顯示防側睡枕能夠阻止SIDS的發生。相反，衛生管理者說，它們倒確實可能提高嬰兒突然死亡的概率。致嬰兒猝死的首要危險因素 就是讓他們趴着睡覺，而衛生部官員經常提醒家長們要讓嬰兒平躺着睡。他們甚至還在上世紀90年代發動了“躺着睡大覺(Back to Sleep)”運動，此舉大幅度降低了嬰兒猝死案例。
如果嬰兒在使用防側睡枕時翻轉成趴着的姿勢，他們的嘴和鼻子就可能壓在側面的軟長枕或是其他部位上，從而窒息。即使一開始是躺着睡的，他們也會在枕 頭裡面上下移動。美國食品藥品監督管理局（Food and Drug Administration，簡稱FDA）護理顧問蓋爾·甘特(Gail Gantt)在一封電子郵件中提到：“他們可能把臉陷在軟長枕里，或卡在防側睡枕和嬰兒床床沿之間，”或者小孩子可能從楔形墊上頭朝下滑下來，把嘴巴和鼻 子壓在防側睡枕上。
“嬰兒會動來動去，防側睡枕可能翻到寶寶身上去，把寶寶卡在下面或是防側睡枕和床沿中間，”她說。
自1997年起13名因防側睡枕而窒息的嬰兒中，大多數因為翻轉成趴着的姿勢而窒息死亡。FDA在一份聲明中說，消費品安全委員會已接到十幾例報告，稱小孩子最初是平躺或側躺在防側睡枕上的，但後來被發現“正以很危險的姿勢處於枕頭內或旁邊”。
很多寫給年輕父母的育兒書籍都特別反對使用防側睡枕。美國兒科學會(American Academy of Pediatrics)也不支持利用防側睡枕預防SIDS的做法。儘管FDA從未認可防側睡枕有防止SIDS的功效，但它確實批准過一些用以預防胃食管返 流疾病和扁頭綜合症的器械。但鑒於新的安全性數據，FDA認為防側睡枕令嬰兒窒息的風險比它能帶來的任何益處都要嚴重得多。
自11月21日起，FDA明確建議家長停止使用防側睡枕，並要求製造商提供臨床數據以證明使用此產品的好處大於出現嚴重後果的風險。除了避免此類器械，專家說，家長應該確保枕頭、被褥、圍墊等物品遠離嬰兒和嬰兒床。柔軟的寢具會增加嬰兒窒息的風險。
“最安全的圍欄是‘無圍欄’，”FDA兒科專家蘇珊·卡明斯(Susan Cummins)醫生在聲明中說，“永遠要讓孩子平躺着睡。有種簡單的記憶法：按照‘安全睡眠ABC’來做：單獨、平躺、無圍欄。”
“我們敦促家長和護理人員認真對待我們的警示，不要再使用此類防側睡枕。”美國消費品安全委員會(Consumer Product Safety Commission)主席伊涅絲·特南鮑姆(Inez Tenenbaum)在聲明中說。
防側睡枕的製造商宣稱，讓嬰兒保持特定睡姿可以避免諸多問題，包括胃食道返流和扁頭綜合征——頭骨一部分受壓導致的頭部變形。許多製造商還向家長們 宣傳，防側睡枕可以幫助降低嬰兒猝死綜合症（SIDS: sudden infant death syndrome，每年有數以千計的嬰兒因此死亡，以2-4個月大的嬰兒居多）的風險。
然而，從沒有任何研究顯示防側睡枕能夠阻止SIDS的發生。相反，衛生管理者說，它們倒確實可能提高嬰兒突然死亡的概率。致嬰兒猝死的首要危險因素 就是讓他們趴着睡覺，而衛生部官員經常提醒家長們要讓嬰兒平躺着睡。他們甚至還在上世紀90年代發動了“躺着睡大覺(Back to Sleep)”運動，此舉大幅度降低了嬰兒猝死案例。
如果嬰兒在使用防側睡枕時翻轉成趴着的姿勢，他們的嘴和鼻子就可能壓在側面的軟長枕或是其他部位上，從而窒息。即使一開始是躺着睡的，他們也會在枕 頭裡面上下移動。美國食品藥品監督管理局（Food and Drug Administration，簡稱FDA）護理顧問蓋爾·甘特(Gail Gantt)在一封電子郵件中提到：“他們可能把臉陷在軟長枕里，或卡在防側睡枕和嬰兒床床沿之間，”或者小孩子可能從楔形墊上頭朝下滑下來，把嘴巴和鼻 子壓在防側睡枕上。
“嬰兒會動來動去，防側睡枕可能翻到寶寶身上去，把寶寶卡在下面或是防側睡枕和床沿中間，”她說。
自1997年起13名因防側睡枕而窒息的嬰兒中，大多數因為翻轉成趴着的姿勢而窒息死亡。FDA在一份聲明中說，消費品安全委員會已接到十幾例報告，稱小孩子最初是平躺或側躺在防側睡枕上的，但後來被發現“正以很危險的姿勢處於枕頭內或旁邊”。
很多寫給年輕父母的育兒書籍都特別反對使用防側睡枕。美國兒科學會(American Academy of Pediatrics)也不支持利用防側睡枕預防SIDS的做法。儘管FDA從未認可防側睡枕有防止SIDS的功效，但它確實批准過一些用以預防胃食管返 流疾病和扁頭綜合症的器械。但鑒於新的安全性數據，FDA認為防側睡枕令嬰兒窒息的風險比它能帶來的任何益處都要嚴重得多。
自11月21日起，FDA明確建議家長停止使用防側睡枕，並要求製造商提供臨床數據以證明使用此產品的好處大於出現嚴重後果的風險。除了避免此類器械，專家說，家長應該確保枕頭、被褥、圍墊等物品遠離嬰兒和嬰兒床。柔軟的寢具會增加嬰兒窒息的風險。
“最安全的圍欄是‘無圍欄’，”FDA兒科專家蘇珊·卡明斯(Susan Cummins)醫生在聲明中說，“永遠要讓孩子平躺着睡。有種簡單的記憶法：按照‘安全睡眠ABC’來做：單獨、平躺、無圍欄。”
沒有留言:
張貼留言