Abbreviations
- AAP
American Academy of Pediatrics
- NICE
National Institute for Health and Care Excellence
- SIDS
Sudden Infant Death Syndrome
- SUDI
Sudden Unexplained Death in Infancy
Context and Policy Issues
Sudden Infant Death Syndrome (SIDS) is defined as the sudden and unexplained death of an infant under the age of one (i.e., death for which a cause is not found even after a thorough investigation including review of clinical history, examination of death scene and a complete autopsy).1 Sudden unexplained death in infancy (SUDI) also known as Sudden unexplained infant death is a term used to describe sudden, unexpected and unexplained death of an infant for which external risk factors may be present.2 SUDI is a blanket term that encompasses SIDS, other unexplained infant deaths, and explained infant suffocations.2 SIDS and SUDI are not diagnoses. Risk factors for SIDS fall under three groups: intrinsic risk factors (e.g., male sex, prematurity, exposure to cigarette smoke), extrinsic risk factors (e.g., prone or side sleep position, bed sharing, overheating) and exogenous factors (e.g., ethnicity, climate, geographical location).3 It has been shown that racial and ethnic disparities (such as Indigenous peoples and other racial minorities) and vulnerabilities (such as low socioeconomic status, fewer social supports, those experiencing problems with housing, violence or mental illness) may contribute to increased risk of SIDS.4,5
In Canada, the incidence of SUDI was the highest in 1980 with a rate of 2.07 SUDI per 1,000 live births.6 The rates of SUDI and SIDS have since decreased, especially since the 1990s. In 2018, there were ten deaths classified as SIDS in Canada.7 A global decrease in the incidence of SIDS can be attributed to widespread “Back-to-Sleep” campaigns, which were aimed to promote placing babies in a supine position for sleeping.8,9 Several similar risk reduction strategies, primarily focused on sleep position, have been implemented globally with the aim of reducing the incidence of SIDS and SUDI.5,10 The “Back-to-sleep” campaign was later expanded to the “Safe-to-sleep” campaign in 2012 to involve new and evolved evidence for preventing SIDS.11 As a result of continued research, guidelines regarding the prevention of SIDS and SUDI have been developed and updated throughout the last three decades.
A previous CADTH Summary of Abstracts report, published in 2016, briefly summarized evidence-based guidelines for the prevention of SIDS.12 The purpose of this report is to summarize and critically appraise evidence-based guidelines that were published within the last five years regarding interventions for the prevention of SIDS or SUDI.
Research Question
What are the evidence-based guidelines regarding interventions for the prevention of Sudden Infant Death Syndrome or Sudden Unexplained Death in Infancy in the community?
Key Findings
Two evidence-based guidelines were identified regarding interventions for the prevention of Sudden Infant Death Syndrome (SIDS) and Sudden Unexplained Death in Infancy.
The American Academy of Pediatrics (AAP) guideline recommends always placing infants in the supine position (on the back) to sleep, on a firm and separate surface without any soft or loose objects in the parental room (room sharing) for the first year of life. The AAP further recommend: breastfeeding, infant immunization in accordance with existing guidelines, avoidance of prenatal and post-natal exposure to smoke, supervised and awake tummy time, and that care be taken to avoid overheating. The AAP suggests that pacifiers can be used. Home cardiorespiratory monitoring devices are not recommended to reduce the risk of SIDS, and there was no evidence to recommend swaddling as a risk reduction strategy for SIDS. The AAP guideline also recommends continuing safe sleeping campaigns, continued research and accurate media messaging.
The second guideline, developed by the National Institute for Health and Care Excellence (NICE), focused mainly on post-natal care of women and babies, and advises healthcare providers to discuss the association between co-sleeping or bedsharing and risk of SIDS with parents.
Methods
Literature Search Methods
A limited literature search was conducted by an information specialist on key resources including MEDLINE, the Cochrane Library, the University of York Centre for Reviews and Dissemination (CRD) databases, the websites of Canadian and major international health technology agencies, as well as a focused internet search. The search strategy was comprised of both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search concepts were Sudden Infant Death Syndrome (SIDS) and infant sleep safety. Search filters were applied to limit retrieval to guidelines. Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between January 1, 2015 and August 12, 2020.
Selection Criteria and Methods
One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in .
Exclusion Criteria
Articles were excluded if they did not meet the selection criteria outlined in , they were duplicate publications, or were published prior to 2015. Guidelines with unclear methodology were excluded.
Critical Appraisal of Individual Studies
The included publications were critically appraised by one reviewer using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument13 for guidelines. Summary scores were not calculated for the included guidelines; rather, the strengths and limitations of each included guideline were described narratively.
Quantity of Research Available
A total of 61 citations were identified in the literature search. Following screening of titles and abstracts, 48 citations were excluded and 13 potentially relevant reports from the electronic search were retrieved for full-text review. Four potentially relevant publications were retrieved from the grey literature search for full-text review. Of these potentially relevant articles, 15 publications were excluded for various reasons. Two evidence-based met the inclusion criteria and were included in this report.14,15
Appendix 1 presents the PRISMA16 flowchart of the study selection. Additional references of potential interest are provided in Appendix 5.
Summary of Study Characteristics
Two evidence-based guidelines14,15 were included in this report. One guideline15 provided broad recommendations for post-natal care of women and babies up to eight weeks after delivery and infant sleeping guidelines for children up to one year after birth. Recognizing that not all infant caregivers are “parents”, when the term “parent” was used in the included guidelines we retained this term in our reporting. The characteristics and recommendations relevant to the current report are summarized below. Additional details regarding the characteristics of the included guidelines are provided in Appendix 2.
Study Design
Two evidence-based guidelines for the prevention of SIDS and SUDI were identified.14,15 One guideline was developed by the American Academy of Pediatrics (AAP).14 The guideline was published in 2016 as an update of its previous version which was published in 2011.17 The second guideline was developed by the National Institute of Health and Care Excellence (NICE).15 The NICE guideline was developed in 2006, updated in 2014, and amended in 2015 to include a post-publication change.
The AAP guideline14 was developed by a task force, who conducted a systematic literature search focusing on articles published since 2011 (since the previous update).4 The team also consulted a statistician. The draft version of the guideline was submitted to the relevant committees and the final draft was approved by the AAP executive committee. The guideline developers used the Strength of Recommendation Taxonomy (SORT) tool to determine the strength of recommendations. There were three levels of recommendation based on the availability and quality of evidence, as follows. Level A recommendations were based on good-quality patient-oriented evidence; Level B recommendations were based on inconsistent or limited-quality patient-oriented evidence; and Level C recommendations were based on evidence from consensus, disease-oriented evidence, usual practice, expert opinion, or case series.14 The quantity and quality of evidence were not reported.
The NICE guideline15 was developed by a multidisciplinary team who conducted systematic literature searches of multiple databases in 2014 (date limits for the searches were not specified). The development team identified 13 relevant studies through the searches, and an additional study was identified by the topic-specific committee members. The authors used a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach for rating the quality of evidence. The method for assigning the strength of recommendations was not explicitly reported, however the strength of recommendation was indicated in the wording of each individual recommendation. For the recommendations relevant to the current report, the term “association” was used based on the nature of evidence found. A cause effect relationship between co-sleeping and SIDS was not identified; for this reason, the guideline developers refrained from using the term “risk” while making recommendations.18 The guideline was finalized after public consultation.
Country of Origin
The AAP guideline14 was developed in the USA and the NICE guideline15 was developed in the UK. Both guidelines provided recommendations that could be applied globally.
Patient Population
The patient population of the guidelines14,15 was infants under the age of one year. The intended users of the AAP guidelines14 are anyone who is taking care of infants. Some recommendations are specifically aimed at health policy makers, researchers, and professionals who care for infants. Although the intended users of the NICE guidelines15 are not clearly defined, the recommendations are for health care professionals caring for infants.
Interventions and Comparators
The AAP guideline14 considered several interventions for the preventions of SIDS and SUDI. They included: sleep position, sleep surface, breastfeeding, infant sleep location, bedding, prenatal and post-natal exposures, overheating, immunization, pacifier use, home monitor use, tummy time, swaddling, potential toxicants, hearing screens along with educational interventions, media messages, and research.
The NICE guideline15 provided recommendations regarding co-sleeping.
Outcomes
The outcome considered in the AAP guideline14 was the incidence of SIDS and SUDI. The relevant outcome considered in the NICE guideline was the incidence of SIDS.15
Summary of Critical Appraisal
The evidence-based guidelines14,15 were critically appraised using AGREE II checklist.13 A summary of the critical appraisal is described below, and additional details regarding the AGREE II evaluation of the included guidelines are provided in Appendix 3.
The two included guidelines14,15 described their objectives and the health questions covered clearly. The population of interest and the target users of the guideline were also reported (or implied) by both guidelines. The AAP guidelines were developed by task force of clinical experts.14 The NICE guidelines were developed by a multidisciplinary team including clinical experts of various specialties and lay members.15 The developers of the NICE guideline15 finalized the recommendations after consulting with the public whereas the AAP guideline14 did not seek the views and preferences of the indented users of the guideline from the community (caregivers of infants). regarding the developed recommendations. There were no conflicts of interest for the development teams, and the funding sources did not appear to have influenced the development and reporting of the recommendations.14,15
As for the rigor of development, both guidelines14,15 employed a systematic search for evidence which was reported in evidence documents that accompanied the guidelines.4,18 The methods for formulating the recommendations, and the clinical evidence supporting each recommendation, were described. The guidelines were planned to be updated regularly (every five years for the AAP guideline and three years for the NICE guideline, or as needed) The evidence identified, quality of evidence, and summary of evidence were described in detail in the evidence document of the NICE guideline.18 The quantity of evidence identified, criteria for selecting the evidence, and quality assessment of the evidence were not reported for the AAP guideline.14
Recommendations from both guidelines were reported with clarity.14,15 The specific recommendations were unambiguous and easily identifiable. Recommendations regarding co-sleeping were provided in a subsection in the NICE guideline.15 While several risk factors of SIDS, such as sleep position, sleep surface, breastfeeding, or overheating, were not addressed, it should be noted they were not considered within scope for the guideline update. The recommendations from AAP guideline14 had greater applicability to the current report as the guideline described potential barriers and facilitators to following the recommendations and offered clear advice on use of tools to aid in implementing the recommendations. However, neither of the guidelines considered cultural values or exogenous risk factors associated with vulnerable populations, in development of the recommendations. As Indigenous communities, other ethnic and racial minorities, and vulnerable families may be at increased risk of SIDS,5,17 recommendations that consider cultural values and practices could be beneficial. Lastly, although the included guidelines were developed in UK and the US, the recommendations could be applicable to Canadian settings, given the nature of recommendations.
Summary of Findings
The recommendations from the included guidelines14,15 are summarized below. Appendix 4 presents additional details on recommendations.
Guidelines
Recommendations regarding sleep position
The AAP guideline14 recommends that infants be placed in a supine position for every sleep until the first birthday (recommendation strength: Level A).14 Additionally, evidence showed that this sleeping position did not increase risk of choking and aspiration, even in infants with gastroesophageal reflux. This recommendation is also applied to preterm infants. Skin to skin care is recommended for all mothers and newborns as soon as possible after birth, after which the baby should be placed in a supine position in the bassinet. Once an infant is able to roll from supine to prone position during sleep, the infant can remain in the assumed position.4
Recommendations regarding sleep surfaces
The AAP guideline14 recommends that infants be placed to sleep on a firm sleep surface (recommendation strength: Level A).14 The firm sleep surface can be covered by a fitted sheet and should be devoid of any other objects (e.g., pillows, cushions, other bedding). The AAP also recommends a crib, bassinet, play yard, or portable crib that conforms to the safety standard of the Consumer Product Safety Commission Newer cribs are preferred due to this safety standard. There was insufficient evidence to provide a recommendation regarding bedside sleepers attached to the side of a caregiver’s bed. The AAP recommends against placing an infant on adult-sized beds for sleep due to risk of entrapment. Additionally, the AAP recommends that sitting devices such as car seats and strollers not be used for the routine sleep of infants at home.14
Recommendations regarding infant sleep location
Both included guidelines14,15 provide recommendations regarding co-sleeping or bed sharing (parent and infant sharing a sleep surface). The AAP guidelines recommend that infants sleep in the parents’ room (room sharing) but on a separate designated infant sleep surface.14 This practice should ideally be continued for the first year, and at least for the first six months of the baby’s life (recommendation strength: Level A).14 The AAP guideline cited evidence from case control studies and case series where bed-sharing (co-sleeping) was associated with increased the risk of SIDS, SUDI, or accidental injury to the infant. If the infant is brought to the adult bed for feeding or comforting, they should be placed back in the separate sleep surface afterward. The guideline did not identify adequate evidence in order to make a recommendation regarding the safety or risk of devices intended to make bed sharing safe. The AAP guideline also notes that surfaces such as armchairs and couches are “extremely dangerous places” for infants, however no recommendation specific to these surfaces was made.14
The NICE guidelines recommend that healthcare providers discuss the association between co-sleeping and SIDS with parents and other infant caregivers.15 There was evidence that the association between co-sleeping and SIDS was likely to be greater with other risk factors such as caregiver (or their partner) smoking, recent alcohol consumption, drug usage, and low birth weight and premature infants. Due to the lack of causal evidence, the NICE guideline used the term “association” in the recommendation and refrained from stronger recommendations.15
Recommendations regarding the use of bedding
The AAP guideline14 provides recommendation regarding the use of bedding. The AAP guideline recommends keeping the infant’s sleep surface devoid of soft objects and loose bedding to lower the risk of suffocation, and SIDS (recommendation strength: Level A).14 Based on evidence suggesting that bumper pads are a factor contributing to entrapment and strangulation, the AAP guideline advises against the use of bumper pads for infants.14
Recommendations regarding the use of pacifier
The AAP guideline14 recommends considering offering pacifiers to infants during bedtime and naptime (recommendation strength: Level A).14 This recommendation was based on evidence of a protective effect of pacifier use on the incidence of SIDS; the protective effect was observed even after the pacifier fell out infants’ mouths during sleep. There was inadequate evidence regarding finger sucking on the incidence of SIDS.4
Recommendations regarding breastfeeding
The AAP guideline14 recommends breastfeeding as breastfeeding was associated with lower risk of SIDS (recommendation strength: Level A).14 The AAP guideline also noted that the protective effect of breastfeeding “increases with exclusivity”, while any amount of breastfeeding had a protective effect against SIDS compared to no breastfeeding.14
Recommendations regarding swaddling
The AAP guideline found insufficient evidence to recommend swaddling to reduce the risk of SIDS (recommendation strength: Level C).14 It was noted that, if swaddled, infants should always be placed in a supine position.
Recommendations regarding tummy time
The AAP guideline14 provides a recommendation regarding “tummy time” (the practice of placing a baby in a prone position). The AAP guideline recommends placing babies in the prone position while awake with supervision to facilitate achieving motor milestones and to mitigate development of positional plagiocephaly (recommendation strength: Level B).14
Recommendations regarding prenatal and post-natal exposures (including smoking and alcohol)
The AAP guideline14 provides recommendations regarding various prenatal and post-natal exposures. Specifically, the AAP guideline recommends that pregnant women obtain regular prenatal care (recommendation strength: Level A).14 The guideline advises against smoking, illicit drug use, and alcohol use during pregnancy and after birth (recommendation strength: Level A).14 As described earlier, the NICE guidelines also recommend advising parents about the higher risk of SIDS associated with co-sleeping when parental smoking, drug use, and recent alcohol use are present.15 The NICE guideline did not make recommendations specific to these exposures other than in relation to co-sleeping.15
Recommendations regarding heating, ventilation and fans
The AAP guidelines14 identified evidence showing an increased risk of SIDS associated with overheating of infants. They recommend avoiding overheating and head covering in infants (recommendation strength: Level A).14 Infants should be dressed appropriately for the sleeping environment. The guideline notes the lack of adequate evidence to recommend use of fans to prevent overheating.4
Recommendations regarding immunization
The AAP guideline14 recommends that infants be immunized according to the vaccine guidelines by AAP and the Centers for Disease Control and Prevention (CDC) recommendations (recommendation strength: Level A).14 There was no evidence suggesting immunization causes SIDS, and there was evidence that suggested vaccination may be protective against SIDS.4,14
Recommendations regarding use of home monitoring devices
The AAP guideline14 recommends against the use of home cardiorespiratory monitoring devices as a strategy to reduce SIDS risk (recommendation strength: Level A). There was no evidence suggesting that the use of home cardiorespiratory monitoring devices decreased the risk of SIDS or of Brief Resolved Unexplained Events (BRUEs). BRUEs were previously thought to be precursors to SIDS, however there was also no evidence of this.4
Recommendations regarding use of other commercial devices
The AAP guidelines recommend avoiding the use of commercial devices that are inconsistent with safe sleep guidelines (recommendation strength: Level B).14 Examples of such devices include wedges and position devices, which have a potential for suffocation and entrapment.
Recommendations regarding potential toxicants and hearing screens
The AAP guidelines14 sought evidence regarding toxicants (e.g., nitrites in drinking water, antimony, phosphorus, or arsenic released from mattresses), however no evidence substantiating a causal relation was identified.4 Additionally, based on available evidence, the AAP guideline advises against the use of newborn hearing screens (i.e., hearing tests) as a valid screening tool for risk of SIDS.4
Recommendations regarding educational interventions
The AAP task force found that intervention campaigns for SIDS, especially regarding infant sleep position, were “extremely effective”.4 There was evidence for the effectiveness of primary care based educational interventions in changing practice. The guideline recommends continuing the “Safe to Sleep” campaign. It is recommended that pediatricians and other primary care providers actively participate in this campaign (recommendation strength: Level A)14 Healthcare professionals, staff in newborn nurseries and Neonatal Intensive Care Units (NICUs), and childcare providers should endorse and model recommendations for SIDS risk reduction among infants from their birth.4
Recommendations regarding media messages and other recommendations for policy makers and researchers
The AAP guidelines14 recommend that research and surveillance on the risk factors of SIDS be continued, along with future research on the pathophysiologic mechanisms of SIDS and other sleep-related infant deaths, with the ultimate aim of eliminating these deaths altogether (recommendation strength: Level C).14
The AAP guidelines also recommend that the media and manufacturers follow safe sleep guidelines in advertising and messaging (recommendation strength: Level A).14
Limitations
The main limitation of this report was the limited quantity of guidelines identified. Only two systematically developed guidelines, that were published in 201614 and 2015,15 were identified. The evidence-based guidelines were developed in USA14 and UK;15 no guidelines that were developed in Canada were identified. However, the recommendations could be generalizable to Canadian settings given the commonalities in practice. The recommendations provided by the guidelines were not inclusive of cultural values and exogenous risk factors associated with vulnerable population. As Indigenous communities, other ethnic and racial minorities, and vulnerable families are at increased risk of SIDS,5 recommendations inclusive of cultural values and practices could be beneficial.
Conclusions and Implications for Decision or Policy Making
Two evidence-based guidelines regarding interventions for the prevention of SIDS and SUDI in the community were identified and summarized in this report.14,15 A previous CADTH report,12 published in 2016, found recommendations that are consistent with the current report. These recommendations focused on providing education to parents and caregivers regarding interventions for prevention of SIDS. Interventions included sleep positions, sleep surfaces, sleep location (co-sleeping), pacifier use, smoke exposure, breastfeeding and immunization. The current report builds on the previous report, and reflects recent guidelines based on current evidence.
The two included guidelines, developed by the AAP and NICE,14,15 provided recommendations regarding co-sleeping or bed-sharing. Specifically, the NICE guideline15 recommends that healthcare professionals discuss this association between co-sleeping and SIDS with the parents or carers of infants. The AAP guideline recommends room sharing but recommends against co-sleeping for infants. The AAP guidelines14 further recommend always placing infants in a supine position for sleep, on a firm sleep surface (separate from but close to the caregivers’ sleep surface) that is devoid of bedding and soft objects. The AAP guidelines also recommend: breastfeeding; optional pacifier use; avoidance of overheating, smoke exposure, and parental use of alcohol and illicit drugs; vaccination in accordance with other guidelines; and supervised and awake tummy time. Home cardiorespiratory monitoring devices are not recommended to reduce risk of SIDS There was no evidence to recommend swaddling as a risk reduction strategy for SIDS. The AAP guideline recommends continuing “safe sleeping” campaigns and calls for healthcare providers to participate in and endorse these campaigns. They recommend that media messaging and manufacturers follow safe sleep guidelines in advertising, and healthcare professionals actively endorse recommendations for SIDS reduction among infants from their time of birth. Most of the recommendations were supported by evidence described as “good quality” and “patient-oriented” by the guideline developers.
Overall, the recommendations from AAP14 and NICE15 were of good quality, supported by evidence and developed with sound methodology and are generalizable to Canadian settings. These recommendations are consistent with Canadian guidelines that were published in 2011,19 and with infant sleep safety guidelines used in other industrialized countries (such as Italy, Denmark, New Zealand and Australia) that were either not considered evidence-based or published prior to 2015.20 Focus on research and recommendations inclusive of various cultural practices and addressing Indigenous populations and other minorities as well as vulnerable families is needed.
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Appendix 1. Selection of Included Studies
Appendix 5. Further Information
Guidelines with unclear methodology
Other articles of interest
Doering
JJ, Salm Ward
TC, Strook
S, Campbell
JK. A Comparison of Infant Sleep Safety Guidelines in Nine Industrialized Countries.
J Community Health. 2019
02;44(1):81–87.
PubMed: PM30019197 [
PubMed: 30019197]
About the Series
CADTH Rapid Response Report: Summary with Critical Appraisal
Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
Suggested citation:
Interventions for the Prevention of Sudden Infant Death Syndrome and Sudden Unexplained Death in Infancy: A Review of Guidelines. Ottawa: CADTH; 2020 September. (CADTH rapid response report: summary with critical appraisal).
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