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Organizational Principles to Guide and Define the Care System and/or Improve the Health of all Children

POLICY STATEMENT SIDS and Other -Related Infant : Expansion of Recommendations for a Safe Infant Sleeping Environment

TASK FORCE ON SUDDEN INFANT SYNDROME abstract KEY WORDS Despite a major decrease in the incidence of sudden infant death syn- SIDS, sudden infant death, , sleep position, - sharing, tobacco, pacifier, , bedding, sleep surface drome (SIDS) since the American Academy of (AAP) released ABBREVIATIONS its recommendation in 1992 that infants be placed for sleep in a non- SIDS—sudden infant death syndrome prone position, this decline has plateaued in recent years. Concur- SUID—sudden unexpected infant death rently, other causes of sudden unexpected infant death that occur AAP—American Academy of Pediatrics during sleep (sleep-related deaths), including suffocation, asphyxia, This document is copyrighted and is property of the American and entrapment, and ill-defined or unspecified causes of death have Academy of Pediatrics and its Board of Directors. All authors have filed conflict of interest statements with the American increased in incidence, particularly since the AAP published its last Academy of Pediatrics. Any conflicts have been resolved through statement on SIDS in 2005. It has become increasingly important to a process approved by the Board of Directors. The American address these other causes of sleep-related infant death. Many of the Academy of Pediatrics has neither solicited nor accepted any commercial involvement in the development of the content of modifiable and nonmodifiable risk factors for SIDS and suffocation are this publication. strikingly similar. The AAP, therefore, is expanding its recommenda- tions from focusing only on SIDS to focusing on a safe sleep environ- ment that can reduce the risk of all sleep-related infant deaths, includ- ing SIDS. The recommendations described in this policy statement include supine positioning, use of a firm sleep surface, , room-sharing without bed-sharing, routine , consider- ation of using a pacifier, and avoidance of soft bedding, overheating, and exposure to tobacco smoke, alcohol, and illicit drugs. The rationale for these recommendations is discussed in detail in the accompanying “Technical Report—SIDS and Other Sleep-Related Infant Deaths: Expansion www.pediatrics.org/cgi/doi/10.1542/peds.2011-2284 of Recommendations for a Safe Infant Sleeping Environment,” which is doi:10.1542/peds.2011-2284 included in this issue of Pediatrics (www.pediatrics.org/cgi/content/full/ All policy statements from the American Academy of Pediatrics 128/5/e1341). Pediatrics 2011;128:1030–1039 automatically expire 5 years after publication unless reaffirmed, revised, or retired at or before that time. INTRODUCTION PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). Sudden infant death syndrome (SIDS) is a cause assigned to infant Copyright © 2011 by the American Academy of Pediatrics deaths that cannot be explained after a thorough case investigation, including a scene investigation, autopsy, and review of the clinical history.1 Sudden unexpected infant death (SUID), also known as sudden unexpected death in infancy, is a term used to describe any sudden and unexpected death, whether explained or unexplained (including SIDS), that occurs during infancy. After case investigation, SUIDs can be at- tributed to suffocation, asphyxia, entrapment, , ingestions, metabolic diseases, arrhythmia-associated cardiac channelopathies, and trauma (accidental or nonaccidental). The distinction between SIDS and other SUIDs, particularly those that occur during an observed or unobserved sleep period (sleep-related infant deaths), such as ac-

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TABLE 1 Summary and Strength of Recommendations Level A recommendations Back to sleep for every sleep Use a firm sleep surface Room-sharing without bed-sharing is recommended Keep soft objects and loose bedding out of the crib Pregnant women should receive regular prenatal care Avoid smoke exposure during and after birth Avoid alcohol and illicit drug use during pregnancy and after birth Breastfeeding is recommended Consider offering a pacifier at nap time and bedtime Avoid overheating Do not use home cardiorespiratory monitors as a strategy for reducing the risk of SIDS Expand the national campaign to reduce the risks of SIDS to include a major focus on the safe sleep environment and ways to reduce the risks of all sleep- related infant deaths, including SIDS, suffocation, and other accidental deaths; pediatricians, family , and other primary care providers should actively participate in this campaign Level B recommendations Infants should be immunized in accordance with recommendations of the AAP and Centers for Disease Control and Prevention Avoid commercial devices marketed to reduce the risk of SIDS Supervised, awake is recommended to facilitate development and to minimize development of positional plagiocephaly Level C recommendations Health care professionals, staff in newborn nurseries and NICUs, and providers should endorse the SIDS risk-reduction recommendations from birth Media and manufacturers should follow safe-sleep guidelines in their messaging and advertising Continue research and surveillance on the risk factors, causes, and pathophysiological mechanisms of SIDS and other sleep-related infant deaths, with the ultimate goal of eliminating these deaths entirely These recommendations are based on the US Preventive Services Task Force levels of recommendation (www.uspreventiveservicestaskforce.org/uspstf/grades.htm). Level A: Recommendations are based on good and consistent scientific evidence (ie, there are consistent findings from at least 2 well-designed, well-conducted case-control studies, a systematic review, or a meta-analysis). There is high certainty that the net benefit is substantial, and the conclusion is unlikely to be strongly affected by the results of future studies. Level B: Recommendations are based on limited or inconsistent scientific evidence. The available evidence is sufficient to determine the effects of the recommendations on health outcomes, but confidence in the estimate is constrained by such factors as the number, size, or quality of individual studies or inconsistent findings across individual studies. As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion. Level C: Recommendations are based primarily on consensus and expert opinion.

cidental suffocation, is challenging makers, researchers, and profession- ronment should be used consistently and cannot be determined by autopsy als who care for or work on behalf of for infants up to 1 year of age. Individ- alone. Scene investigation and review infants. In addition, because certain ual medical conditions might warrant of the clinical history are also re- behaviors, such as smoking, can in- that a recommend other- quired. Many of the modifiable and crease risk for the infant, some recom- wise after weighing the relative risks nonmodifiable risk factors for SIDS mendations are directed toward and benefits. and suffocation are strikingly similar. women who are pregnant or may be- For the background literature review This document focuses on the subset come pregnant in the near future. and data analyses on which this policy of SUIDs that occurs during sleep. Table 1 summarizes the major recom- statement and recommendations are The recommendations outlined herein mendations, along with the strength of based, please refer to the accompany- were developed to reduce the risk of each recommendation. It should be ing “Technical Report—SIDS and Other SIDS and sleep-related suffocation, as- Sleep-Related Infant Deaths: Expansion noted that there have been no random- phyxia, and entrapment among infants of Recommendations for a Safe Infant ized controlled trials with regards to in the general population. As defined Sleeping Environment,” available in the SIDS and other sleep-related deaths; by epidemiologists, risk refers to the online version of this issue of instead, case-control studies are the probability that an outcome will occur Pediatrics.2 standard. given the presence of a particular fac- tor or set of factors. Although all of the Because most of the epidemiologic RECOMMENDATIONS 18 recommendations cited below are studies that established the risk fac- 1. Back to sleep for every intended for , health care pro- tors and on which these recommenda- sleep—To reduce the risk of viders, and others who care for in- tions are based include infants up to 1 SIDS, infants should be placed fants, the last 4 recommendations are year of age, these recommendations for sleep in a supine position also directed toward health policy for sleep position and the sleep envi- (wholly on the back) for every

PEDIATRICS Volume 128, Number 5, November 2011 1031 sleep by every caregiver until 1 pated discharge, by 32 weeks’ check to make sure that the year of life.3–7 Side sleeping is not postmenstrual age.15 NICU product has not been re- safe and is not advised.4,6 personnel should endorse called. Cribs with missing a. The supine sleep position safe-sleeping guidelines with hardware should not be used, does not increase the risk of parents of infants from the and the or provider choking and aspiration in in- time of admission to the NICU. should not attempt to fix bro- fants, even those with gastro- c. There is no evidence that ken components of a crib, be- esophageal reflux, because placing infants on the side cause many deaths are asso- they have protective airway during the first few hours of ciated with cribs that are mechanisms.8,9 Infants with life promotes clearance of broken or have missing parts gastroesophageal reflux amniotic fluid and decreases (including those that have should be placed for sleep in the risk of aspiration. Infants presumably been fixed). Local the supine position for every in the newborn and organizations throughout the sleep, with the rare exception infants who are rooming in United States can help to pro- of infants for whom the with their parents should be vide low-cost or free cribs or risk of death from complica- placed in the supine position yards for families with fi- tions of gastroesophageal re- as soon as they are ready to nancial constraints. flux is greater than the risk of be placed in the bassinet. b. Only mattresses designed for SIDS (ie, those with upper air- d. Although data to make spe- the specific product should way disorders, for whom air- cific recommendations as to be used. Mattresses should way protective mechanisms when it is safe for infants to be firm and maintain their are impaired),10 including in- sleep in the prone or side po- shape even when the fitted fants with anatomic abnormal- sition are lacking, studies sheet designated for that ities such as type 3 or 4 laryn- that have established prone model is used, such that geal clefts who have not and side sleeping as risk fac- there are no gaps between undergone antireflux surgery. tors for SIDS include infants the mattress and the side of Elevating the head of the in- up to 1 year of age. Therefore, the crib, bassinet, portable fant’s crib while the infant is infants should continue to be crib, or play yard. Pillows or supine is not recommended.11 placed supine until 1 year of cushions should not be used It is ineffective in reducing gas- age. Once an infant can roll as substitutes for mattresses troesophageal reflux; in addi- from supine to prone and or in addition to a mattress. tion, it might result in the infant from prone to supine, the in- Soft materials or objects sliding to the foot of the crib fant can be allowed to remain such as pillows, quilts, com- into a position that might com- in the sleep position that he forters, or sheepskins, even if promise respiration. or she assumes. covered by a sheet, should b. Preterm infants are at in- 2. Use a firm sleep surface—A firm not be placed under a sleep- ing infant. If a mattress cover creased risk of SIDS,12,13 and crib mattress, covered by a fit- the association between ted sheet, is the recommended to protect against wetness is prone sleep position and SIDS sleeping surface to reduce the used, it should be tightly fit- among low in- risk of SIDS and suffocation. ting and thin. fants is equal to, or perhaps a. A crib, bassinet, or portable c. Infants should not be placed even stronger than, the asso- crib/play yard that conforms for sleep on beds because of ciation among those born at to the safety standards of the the risk of entrapment and term.14 Preterm infants and Consumer Product Safety suffocation.17,18 In addition, other infants in the NICU Commission and ASTM Inter- portable bed rails should not should be placed in the su- national (formerly the Ameri- be used with infants because pine position for sleep as can Society for Testing of the risk of entrapment and soon as the infant is medi- and Materials) is recom- strangulation. cally stable and significantly mended.16 In addition, par- d. The infant should sleep in an before the infant’s antici- ents and providers should area free of hazards, such

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as dangling cords, electric should be placed in the par- parents that they avoid the wires, and window-covering ents’ bedroom close to the following situations at all cords, because they might parents’ bed. This arrange- times: present a strangulation risk. ment reduces SIDS risk and i. Bed-sharing when the in- e. Sitting devices, such as car removes the possibility of suf- fant is younger than 3 safety seats, strollers, focation, strangulation, and months, regardless of swings, infant carriers, and entrapment that might occur whether the parents are infant slings, are not recom- when the infant is sleeping in smokers or not.5,7,31–34 the ’ bed. It also allows mended for routine sleep in ii. Bed-sharing with a current 19–23 close parental proximity to the hospital or at home. smoker (even if he or she the infant and facilitates feed- Infants who are younger than does not smoke in bed) or if ing, comforting, and monitor- 4 months are particularly at the smoked during ing of the infant. risk, because they might as- pregnancy.5,6,34–36 sume positions that can cre- b. Devices promoted to make iii. Bed-sharing with someone ate risk of suffocation or air- bed-sharing “safe” (eg, in- who is excessively tired. way obstruction. When co-sleepers) are not slings and cloth carriers are recommended. iv. Bed-sharing with some- one who has or is using used for carrying, it is impor- c. Infants may be brought into medications (eg, certain tant to ensure that the in- the bed for feeding or com- , pain fant’s head is up and above forting but should be re- medications) or sub- the fabric, the is visible, turned to their own crib or stances (eg, alcohol, il- and that the nose and mouth bassinet when the parent is 24 licit drugs) that could im- are clear of obstructions. Af- ready to return to sleep.6,32 pair his or her alertness ter nursing, the infant should Because of the extremely high or ability to arouse.7,37 be repositioned in the sling so risk of SIDS and suffocation that the head is up, is clear of on couches and arm- v. Bed-sharing with anyone fabric, and is not against the chairs,3,5,6,31,32 infants should who is not a parent, in- ’s body or the sling. If an not be fed on a couch or arm- cluding other children.3 infant falls asleep in a sitting chair when there is a high vi. Bed-sharing with multi- device, he or she should be risk that the parent might fall ple persons.3 removed from the product asleep. vii. Bed-sharing on a soft and moved to a crib or other d. Epidemiologic studies have surface such as a water- appropriate flat surface as not demonstrated any bed- bed, old mattress, sofa, soon as is practical. Car sharing situations that are couch, or armchair.3,5,6,31,32 safety seats and similar prod- protective against SIDS or ucts are not stable on a crib viii. Bed-sharing on a surface suffocation. Furthermore, not mattress or other elevated with soft bedding, including all risks associated with bed- surfaces.25–29 pillows, heavy blankets, sharing, such as parental fa- quilts, and comforters.3,38 3. Room-sharing without bed- tigue, can be controlled. e. It is prudent to provide sepa- sharing is recommended— Therefore, the American rate sleep areas and avoid co- There is evidence that this ar- Academy of Pediatrics (AAP) bedding for and higher- rangement decreases the risk of does not recommend any 5,7,30,31 order multiples in the SIDS by as much as 50%. In specific bed-sharing situa- hospital and at home.39 addition, this arrangement is tions as safe. Moreover, there most likely to prevent suffoca- are specific circumstances 4. Keep soft objects and loose bed- tion, strangulation, and entrap- that, in epidemiologic stud- ding out of the crib to reduce the ment that might occur when the ies, substantially increase risk of SIDS, suffocation, entrap- infant is sleeping in an adult bed. the risk of SIDS or suffocation ment, and strangulation. a. The infant’s crib, portable while bed-sharing. In particu- a. Soft objects, such as pillows and crib, play yard, or bassinet lar, it should be stressed to pillow-like toys, quilts, comfort-

PEDIATRICS Volume 128, Number 5, November 2011 1033 ers, and sheepskins, should be shares with an adult reinserted once the infant kept out of an infant’s sleeping smoker.5,6,34–36 falls asleep. If the infant re- environment.40–45 7. Avoid alcohol and illicit drug use fuses the pacifier, he or she b. Loose bedding, such as blan- during pregnancy and after should not be forced to take kets and sheets, might be birth—There is an increased it. In those cases, parents can hazardous and should not be risk of SIDS with prenatal and try to offer the pacifier again used in the infant’s sleeping postnatal exposure to alcohol or when the infant is a little environment.3,6,46–51 illicit drug use. older. c. Because there is no evidence a. should avoid alco- b. Because of the risk of stran- that bumper pads or similar hol and illicit drugs pericon- gulation, pacifiers should not be hung around the infant’s products that attach to crib ceptionally and during 64–70 neck. Pacifiers that attach to slats or sides prevent injury pregnancy. infant should not be in young infants and because b. Parental alcohol and/or illicit used with sleeping infants. there is the potential for suf- drug use in combination with focation, entrapment, and bed-sharing places the infant c. Objects such as stuffed toys, strangulation, these products at particularly high risk of which might present a suffo- are not recommended.52,53 SIDS.7,37 cation or choking risk, should not be attached to pacifiers. d. Infant sleep clothing that is 8. Breastfeeding is recommended. d. For breastfed infants, delay designed to keep the infant a. Breastfeeding is associated pacifier introduction until warm without the possible with a reduced risk of breastfeeding has been hazard of head covering or SIDS.71–73 If possible, mothers firmly established,74 usually entrapment can be used. should exclusively breastfeed by 3 to 4 weeks of age. 5. Pregnant women should receive or feed with expressed hu- e. There is insufficient evidence regular prenatal care—There is man (ie, not offer any that finger-sucking is protec- substantial epidemiologic evi- formula or other non– tive against SIDS. dence linking a lower risk of milk–based supplements) SIDS for infants whose mothers for 6 months, in alignment 10. Avoid overheating—Although obtain regular prenatal care.54–57 with recommendations of the studies have revealed an in- AAP.74 creased risk of SIDS with over- 6. Avoid smoke exposure during b. The protective effect of heating,75–78 the definition of pregnancy and after birth— overheating in these studies Both maternal smoking during breastfeeding increases with 73 varied. Therefore, it is difficult pregnancy and smoke in the in- exclusivity. However, any breastfeeding has been to provide specific room- fant’s environment after birth shown to be more protective temperature guidelines for are major risk factors for SIDS. against SIDS than no avoiding overheating. a. Mothers should not smoke breastfeeding.73 a. In general, infants should be during pregnancy or after the 9. Consider offering a pacifier at dressed appropriately for the infant’s birth.1,58–61 nap time and bedtime— environment, with no more b. There should be no smoking Although the mechanism is yet than 1 layer more than an near pregnant women or in- unclear, studies have reported a adult would wear to be com- fants. Encourage families to protective effect of pacifiers fortable in that environment. set strict rules for smoke- on the incidence of SIDS.3,7,32 b. Parents and caregivers free homes and cars and to The protective effect persists should evaluate the infant for eliminate secondhand to- throughout the sleep period, signs of overheating, such as bacco smoke from all places even if the pacifier falls out of sweating or the infant’s chest in which children and other the infant’s mouth. feeling hot to the touch. nonsmokers spend time.62,63 a. The pacifier should be used c. Overbundling and covering of c. The risk of SIDS is particularly when placing the infant for the face and head should be high when the infant bed- sleep. It does not need to be avoided.79

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d. There is currently insufficient There is also no evidence that ginning at birth and well be- evidence to recommend the routine in-hospital cardiorespi- fore anticipated discharge. use of a fan as a SIDS risk- ratory monitoring before dis- c. All physicians, nurses, and reduction strategy. charge from the hospital can other health care profession- 11. Infants should be immunized in ac- identify newborn infants at risk als should receive education cordance with recommendations of SIDS. on safe infant sleep. of the AAP and the Centers for Dis- 14. Supervised, awake tummy time d. All child care providers ease Control and Prevention— is recommended to facilitate should receive education on There is no evidence that there is development and to minimize safe infant sleep and imple- a causal relationship between development of positional ment safe sleep practices. It immunizations and SIDS.80 In- plagiocephaly. is preferable that they have deed, recent evidence suggests a. Although there are no data to written policies. that immunization might have make specific recommenda- 16. Media and manufacturers a protective effect against tions as to how often and how should follow safe-sleep guide- SIDS.81–83 Infants should also be long it should be undertaken, lines in their messaging and seen for regular well-child supervised, awake tummy advertising. checks in accordance with AAP time is recommended on a recommendations. Media exposures (including daily basis, beginning as movie, television, magazines, 12. Avoid commercial devices mar- early as possible, to promote newspapers, and Web sites), keted to reduce the risk of motor development, facilitate SIDS—These devices include manufacturer advertisements, development of the upper and store displays affect individ- wedges, positioners, special body muscles, and minimize mattresses, and special sleep ual behavior by influencing be- the risk of positional liefs and attitudes.89,91 Media and surfaces. There is no evidence plagiocephaly.88 that these devices reduce the advertising messages contrary b. Diagnosis, management, and risk of SIDS or suffocation or to safe-sleep recommendations other prevention strategies that they are safe. might create misinformation for positional plagiocephaly, about safe sleep practices.92 a. The AAP concurs with the US such as avoidance of exces- Food and Drug Administra- 17. Expand the national campaign to sive time in car safety seats reduce the risks of SIDS to in- tion and Consumer Product and changing the infant’s ori- Safety Commission that man- clude a major focus on the safe entation in the crib, are dis- sleep environment and ways to ufacturers should not claim cussed in detail in the recent that a product or device pro- reduce the risks of all sleep- AAP clinical report on posi- related infant deaths, including tects against SIDS unless tional deformities.88 there is scientific evidence SIDS, suffocation, and other acci- to that effect. 15. Health care professionals, staff dental deaths. Pediatricians, in newborn nurseries and neo- family physicians, and other 13. Do not use home cardiorespira- natal intensive care nurseries, primary care providers should tory monitors as a strategy and child care providers should en- actively participate in this to reduce the risk of SIDS— dorse the SIDS risk-reduction rec- campaign. Although cardiorespiratory ommendations from birth.89–91 monitors can be used at home a. Public education should con- to detect apnea, bradycardia, a. Staff in NICUs should model tinue for all who care for in- and, when pulse oximetry is and implement all SIDS risk- fants, including parents, child used, decreases in oxyhemo- reduction recommendations care providers, grandparents, globin saturation, there is no as soon as the infant is clini- foster parents, and baby- evidence that use of such de- cally stable and significantly sitters, and should include vices decreases the incidence before anticipated discharge. strategies for overcoming bar- of SIDS.84–87 They might be of b. Staff in newborn nurseries riers to behavior change. value for selected infants but should model and implement b. The campaign should con- should not be used routinely. these recommendations be- tinue to have a special focus

PEDIATRICS Volume 128, Number 5, November 2011 1035 on the black and American In- timate goal of eliminating these and other primary care pro- dian/Alaskan Native popula- deaths entirely. viders, should be supported tions because of the higher a. Education campaigns need to and funded. incidence of SIDS and other be evaluated, and innovative d. Improved and widespread sleep-related infant deaths in intervention methods need to surveillance of SIDS and SUID these groups. be encouraged and funded. cases should be imple- c. The campaign should specifi- b. Continued research and im- mented and funded. cally include strategies for in- proved surveillance on the e. Federal and private funding creasing breastfeeding while etiology and pathophysiologi- agencies should remain com- decreasing bed-sharing and cal basis of SIDS should be mitted to all aspects of the eliminating tobacco smoke funded. aforementioned research. exposure. c. Standardized protocols for LEAD AUTHOR d. These recommendations should death-scene investigations Rachel Y. Moon, MD be introduced before preg- should continue to be imple- TASK FORCE ON SUDDEN INFANT nancy and ideally in second- mented. Comprehensive au- DEATH SYNDROME, 2010–2011 ary school curricula for topsies that include full exter- Rachel Y. Moon, MD, Chairperson both boys and . The im- nal and internal examination Robert A. Darnall, MD of all major organs and tis- Michael H. Goodstein, MD portance of maternal pre- Fern R. Hauck, MD, MS conceptional health and sues (including the brain), complete radiographs, meta- CONSULTANTS avoidance of substance use Marian Willinger, PhD – Eunice Kennedy (including alcohol and bolic testing, and toxicology Shriver National Institute for Child Health smoking) should be in- screening should be per- and Human Development Carrie K. Shapiro-Mendoza, PhD, MPH – cluded in this training. formed. Training about how to conduct comprehensive Centers for Disease Control and Prevention e. Safe-sleep messages should death-scene investigation of- STAFF be reviewed, revised, and re- James Couto, MA fered to medical examiners, issued at least every 5 years coroners, death-scene inves- ACKNOWLEDGMENTS to address the next genera- tigators, first responders, The task force acknowledges the con- tion of new parents and prod- and law enforcement should tributions provided by others to the ucts on the market. continue, and resources for collection and interpretation of data 18. Continue research and surveil- maintaining training and con- examined in preparation of this report. lance on the risk factors, causes, duct of these investigations The task force is particularly grateful and pathophysiological mecha- need to be allocated. In addi- for the report submitted by Dr Suad nisms of SIDS and other sleep- tion, child death reviews, with Wanna-Nakamura (Consumer Product related infant deaths, with the ul- involvement of pediatricians Safety Commission). REFERENCES

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