There is evidence from a poor quality single study of an association between this protective factor and the outcome of interest. Interventions Advice on safe sleeping NICE has issued guidance on routine post natal care of women and their babies. The guidance includes recommendations specific to the prevention of SIDS. NICE GUIDANCE Routine post natal care of women and their babies Addendum to Clinical guideline 37. Routine postnatal care of women and their babies. This guideline aims to identify the essential core (routine) care that every woman and her baby should receive in the first 6–8 weeks after birth, based on the best evidence available. This guideline is of relevance to those who work in or use the National Health Service (NHS) in England and Wales. The guideline is relevant to prevention of SUID, providing specific recommendations for prevention as well as guidance on establishing breast feeding. In 2013 new information on the association between co-sleeping and sudden infant death syndrome was published. In view of this NICE received a referral from the Department of Health requesting that a surveillance review be carried out in this area. An exceptional surveillance review took place in 2013 and concluded that the section of Postnatal care: routine postnatal care of women and their babies (NICE clinical guideline 37) on reducing the risk of SIDS should be updated. New recommendations on co-sleeping are made in this addendum. They are currently a draft for consultation but have been included in this document. National Institute for Clinical Excellence. 2006. Routine postnatal care of women and their babies. CG37. London: NICE. Access National Institute for Health and Care Excellence. 2014. Addendum to Clinical guideline 37, Postnatal Care. Routine postnatal care of women and their babies. Draft for consultation. NICE CG Addendum 37.1. Manchester: NICE. Access
Study details Results of the review Main findings and evidence grading Bed sharing Vennemann MM et al. 2012. Bed sharing and the risk of sudden infant syndrome: can we resolve the debate? J Pediatr 160 (1): 44-48 Risk factor: Bed sharing Type of source: Systematic review Searches were conducted between: 1 Jan 1970 to December 2009 Study Population: Quality of the review: Followed Moose guidelines. No mention of assessment of publication bias. Little detail on characteristics of included studies. Description of included studies: 11 studies were included yielding 710 SIDS cases and 863 controls. 5 of the included studies were conducted in the UK or Ireland, 3 in the USA, 1 in New Zealand, 1 Norway, 1 Germany. Included Risk factor: Bed sharing Evidence statement C: There is some evidence supporting the hypothesis that this risk factor is causal but it is not conclusive Author’s conclusions: Bed sharing is a risk factor for SIDS and is especially enhanced in smoking parents and in very young infants (< 12 weeks). Comment: This paper also reported odds ratios for smoking versus non smoking parents, age of
SIDs cases not further defined assume <1 year Included study types: Case control studies studies were conducted between 1984 and 2006. Quality of included studies: Provided inclusion criteria for including studies, no included study failed on any of these. There was a moderately large degree of heterogeneity in the analysis (I2 48.5 p= 0.04 with one study excluded; 57.3 p=0.009 when included – OR for bed sharing when this study excluded not provided). Synthesis: Meta-analysis Findings: Eleven studies met inclusion criteria and were included in the final The infant regardless of smoking status and routine sleep location. These have not been included because they used data from studies other than the 11 included studies and no explanation why or detail of these other studies was included in the text. Lack of detail on study quality reduces confidence in findings. There is an overlap with data included in the Carpenter 2013 but some more recent case control studies are included. Did not analyse individual level data as in Carpenter so could not adjust for maternal alcohol and drug use found to be a strong enhancing factor in Carpenter Some included studies counted sofa analysis.
combined OR for SIDS in all bed sharing versus sharing infants was 2.89 (95% CI, sleeping as and this may have increased OR. Studies were included from both before and after the Back to Sleep campaign Study details Results of the study Main findings and evidence grading Bed sharing Carpenter R et al. 2013. Bed sharing when parents do not smoke: is there a risk of SIDS? An individual level analysis of five major case–control studies. BMJ Open (3): e002299 Risk factor: Bed sharing when parents do not smoke Type of source: Quality of the review: This is based on a of 19 studies. These were not selected on the basis of a systematic literature search. The lead authors of the included studies conducted this Detail of the characteristics of the 19 Risk factor: Bed sharing for sleep when parents do not smoke or take alcohol or drugs Evidence statement C: There is some evidence supporting the hypothesis that this risk factor is causal but it is not conclusive Risk factor: Bed sharing and parental smoking analysis.
of case control studies not based on a systematic review Studies were conducted between:1987 and 2003 Population: Infants below 1 year Included types: Case control studies included studies was not provided. Description of included studies: 1472 SIDS cases, and 4679 controls. Each study effectively included all cases, by standard criteria. Controls were normal infants of similar age, time and place, not all appear to have been randomly selected. Included studies were conducted in Europe (contributing countries not further specified), Germany, Scotland, Ireland and New Zealand. Quality of included studies: Little detail on the included studies was provided and Evidence statement C: There is some evidence supporting the hypothesis that this risk factor is causal but it is not conclusive Risk factor: Bed sharing and alcohol use Evidence statement C: There is some evidence supporting the hypothesis that this risk factor is causal but it is not conclusive Author’s conclusions: Bed sharing for when the parents do not smoke or take alcohol or drugs increases the risk of SIDS. Risks associated with bed sharing are greatly increased when combined with parental smoking, maternal alcohol consumption and/or drug use. A substantial reduction of
the parents, the large combined effect showed evidence of a significant interaction. No excess risk was identified from bed sharing with non-smoking parents for infants born at term or birth weight >2500 g. Protective factors Study details Results of the review Main findings and evidence grading Breastfeeding Hauck FR et al. 2011. Breastfeeding and reduced risk of sudden infant death syndrome: a Quality of the review: Search of one database only. No check for publication bias. Protective factor: Breastfeeding Evidence statement C: There is some evidence supporting the hypothesis that this protective factor is
Pediatrics 128 (1): 103-110 Type of source: Systematic review Protective factor: Breastfeeding Study Population: SIDs assume infants up to 1 year Searches were conducted between: Jan 1966 and December 2009 Included study types: Case control studies Description of included studies: 18 studies were included in the meta analysis. 5 were conducted in the UK, 3 USA, 2 Scandinavia, 5 Australasia, 2 Germany, 1 Canada. Included studies were conducted between 1952 and 2003. Quality of included studies: Quality assessed American Academy of Pediatrics Task Force on positioning and SIDS criteria. All included studies met all criteria. Synthesis: Meta analysis Findings: Eighteen case-control studies were included in the causal but it is not conclusive Effect size: Multivariate of 7 case control studies breast feeding versus no breastfeeding SOR 0.55 (95% CI 0.44 to 0.69) Author’s conclusions: Breastfeeding is protective against SIDS, and this effect is stronger when breastfeeding is exclusive. The recommendation to breastfeed infants should be included with other SIDS messages to both reduce the risk of SIDS and promote breastfeeding for its many other infant and maternal health benefits. Comment: Whilst the association appears strong the reliability of the findings is compromised due to reliance on one source of studies and lack of check for publication bias, thus there is the possibility that negative studies have been missed. Further, NICE guidance 37.1 raises concerns about matching in some of the studies.
For infants who received any amount of breast milk for any duration, the univariate SOR was statistically significant at 0.40 (95% confidence interval [CI]: 0.35– 0.44, I2 = 71%). Multivariable ORs were reported for only 7 of the studies and the multivariable SOR was statistically significant at 0.55 (95% CI: I2=40%). studies provided information about any breastfeeding at 2months of age or older. The summary univariable estimate for the 3 studies was 0.38 (95% CI: 0.27– 0.54; I2= 78%). Because only There may be some confusion over the interpretation of I2. Authors state There was no heterogeneity (I2=40%) (Multivariate analysis of breast feeding versus no breastfeeding) but the developers of this approach state that a value of 0% indicates no observed heterogeneity, and larger values show increasing heterogeneity.
with these 5 studies included. The resulting univariable SOR was 0.49 (95% CI: 0.45– 0.53). The multivariable SOR was 0.68 (95% CI: 0.58–0.80). These results are slightly higher than the SORs that excluded the respective studies. Study details Results of the review Main findings and evidence grading Pacifier(dummy) use Hauck FR, Omojokun OO and Siadaty MS. 2005. Do pacifiers reduce the risk of sudden infant death Quality of the review: Literature search limited to Medline. No detail on results of search. Description of included Protective factor: Pacifier use Evidence statement C: There is some evidence supporting the hypothesis that this protective
syndrome? A Pediatrics 116 (5): e716-723 Type of source: Systematic Review Protective factor: Pacifier use Study Population: Infants up to 1 years Searches were conducted between: Jan 1966 and May 2004 Included study types: Case control studies: 7 studies were included in the 1 each conducted in the UK, Europe, USA, Ireland, Scotland, New Zealand, Netherlands. Included studies were conducted between 1984 and 2000. Quality of included studies: Assessed against 6 criteria set by the developed by the American Academy of Pediatrics Task Force on infant positioning and SIDS. 6 of 8 included studies met all criteria. Synthesis: Meta-analysis Findings: Seven studies were included in the meta The factor is causal but it is not conclusive Author’s conclusions: Published studies demonstrate a significant reduced risk of SIDS with pacifier use, particularly when placed for sleep. Encouraging pacifier use is likely to be beneficial on a population-wide basis: 1 SIDS death could be prevented for every 2733 (95% CI: 2416 to 3334) infants who use a pacifier when placed for sleep (number needed to treat), based on the US SIDS rate and the last-sleep multivariate SOR resulting from this Therefore, we recommend that pacifiers be offered to infants as a potential method to reduce the risk of SIDS. The pacifier should
SOR calculated for usual pacifier use (with univariate ORs) is 0.90 (95% CI 0.79 to 1.03) and 0.71 (95% CI 0.59 to 0.85) with multivariate ORs. For pacifier use during last sleep, the SORs calculated using univariate and multivariate ORs are 0.47 (95% CI: 0.40–0.55) and 0.39 (95% CI: 0.31– 0.50), respectively. be offered to the infant when being placed for all sleep episodes, including daytime naps and night time sleeps. This is a US Preventive Services Task Force level B strength of recommendation based on the consistency of findings and the likelihood that the beneficial effects will outweigh any potential negative effects. In consideration of potential adverse effects, we recommend pacifier use for infants up to 1 year of age, which includes the peak ages for SIDS risk and the period in which the infant’s need for sucking is highest. For breastfed infants, pacifiers should be introduced after breastfeeding has been well established.
Comment: Whilst the association appears strong the reliability of the findings is compromised due to reliance on one source of studies and lack of check for publication bias, thus there is the possibility that negative studies have been missed. Study details Results of the study Main findings and evidence grading Use of pacifier (dummy) Li DK et al. 2006. Use of a dummy (pacifier) during sleep and risk of sudden infant death syndrome (SIDS): population based study. BMJ Description of study: Population based case control study involving 11 counties in California. 185 infants and 312 controls Quality of study: Low response rate 50% for cases and 41% for Protective factor: Use of pacifier (dummy) Evidence statement C: Evidence from a poor quality single study of an association between the protective factor and the outcome of interest
332 (7532): 18-22 Study type: Case control Protective factor: Pacifier (dummy) use Study Population: SIDS infants defined as above Duration: 1997 to 2000 controls, no information on non responders. Findings: The adjusted odds ratio for SIDS associated with using a dummy during the last sleep was 0.08 (95% CI 0.03 to 0.21). Use was associated with a reduction in risk in every category of characteristics and risk factors examined. The reduced risk associated with use seemed to be greater with adverse sleep conditions (such as sleeping prone or on side and sleeping with a mother who smoked), although the observed interactions were not significant. In addition, use of a dummy Author’s conclusions: Use of a dummy seems to reduce the risk of SIDS and possibly reduces the influence of known risk factors in the sleep environment. Comment: Study conducted in 11 counties in northern California findings may not generalise to UK or Wales setting. Low response rates and lack of information about increases risk of bias in results. responders
who did (1.1, 0.1 to 13.4). Moon RY et al. 2012. Pacifier use and SIDS: evidence for a consistently reduced risk. Matern Child Health J 16 (3): 609-614 Study type: Case control study Protective factor: Use of dummy Study population. SIDS Duration of study: November 1993 to April 1996 Description of study: Analysis of data from the Chicago Infant Mortality Study (CIMS). 260 SIDs cases and 260 living infant controls matched by maternal race/ethnicity, infant age and birth weight. Information on pacifier use collected via questionnaire 2 weeks after the death that ascertained detail of events leading to the death, risk factors and socioeconomic factors. Quality of study: No information was provided on recruitment of controls. No information on the questionnaire used or how it had been validated. Protective factor: Use of pacifier (dummy) Evidence statement C: is evidence from a poor quality single study of an association between this protective factor and the outcome of interest Author’s conclusions: In the Chicago Infant Mortality Study, a large population based case-control study we found pacifier use to be associated with a reduced risk of SIDS Comment: Study conducted in single city in USA, predominantly African American population recognised as up to 4 times more likely to die from SIDs than white or Hispanic infants – findings may not generalise to UK
was associated with a significantly increased risk of SIDS compared with supine sleeping position (OR 4.46, 95% CI 2.98 to 6.68). Three additional observational studies supported this finding. The authors found no systematic review or RCTs comparing advice to avoid prone sleeping position versus no advice (see comment). They found one non-systematic review (3 observational studies; 1 of which reported separately) and 13 additional observational studies (reported in 13 publications), which described campaigns delivering advice to avoid prone positioning, and a combination of different risk factors and conducted before and after analyses of incidence of SIDS. is good evidence to suggest that this intervention has a sound theoretical basis or that work in this area is likely to have an impact but this has not been demonstrated in trials (this would apply to interventions for which RCTs would be particularly difficult or unethical) Intervention: Advice to soft sleeping surfaces Outcome: Reduction in the incidence of SIDS Evidence statement Grade K: Evidence about the effectiveness of this intervention is lacking Intervention: National campaigns giving advice to overheating or overwrapping
Observational data also suggest that pre- or postnatal exposure to tobacco smoke and hyperthermia or over wrapping may also increase the risk of SIDS. The evidence for effectiveness of advice on smoking is drawn largely from observational studies – no SRs or RCTs. Advice to avoid exposure seems to reduce the incidence of SIDS but the campaigns included other advice in addition to avoiding tobacco-smoke exposure, and in some countries the incidence of SIDS had started to fall before the campaign started. Some national campaigns have included advice to avoid overheating/ overwrapping, in addition to recommendations on other risk Outcome: Reduction in the incidence of SIDS Evidence statement Grade E: There is good evidence to suggest that this intervention has a sound theoretical basis or that work in this area is likely to have an impact but this has not been demonstrated in trials (this would apply to interventions for which RCTs would be particularly difficult or unethical) Intervention: National campaigns giving advice to avoid bed sharing Outcome: Reduction in the incidence of SIDS Evidence statement Grade E: There is good evidence to suggest that this intervention
studies of sufficient quality of the effectiveness of advice on soft sleeping surfaces. Some national campaigns have included advice to avoid bed sharing, in addition to recommendations on other risk factors, and the contribution of avoiding bed sharing to the observed reduction in SIDS is unclear. The authors found no clinically important results from RCTs comparing advice to avoid bed sharing with no advice. One systematic review (23 studies) suggests an association between SIDS and lack of breastfeeding, reporting that the overall risk of SIDS was doubled for bottle-fed infants compared with breastfed infants (OR 2.11, 95% would be particularly difficult or unethical) Intervention: Advice to promote soother/pacifier use Outcome: Reduction in the incidence of SIDS Evidence statement Grade K: Evidence about the effectiveness of this intervention is lacking Intervention: Advice to promote room sharing (without bed sharing) Outcome: Reduction in the incidence of SIDS Evidence statement K: Evidence about the effectiveness of this intervention is lacking Author’s conclusions: In
CI 1.66 to 2.68). A more recent meta-analysis using more selective criteria found that breastfeeding was associated with a reduction in SIDS risk (OR 0.64, 95% CI 0.51 to 0.81).* Two systematic reviews found an association between SIDS and lack of soother or pacifier use. One of the two systematic reviews pooled data, and found a reduced risk of SIDS with pacifier use when used for sleep (OR 0.71, 95% CI 0.59 to 0.85). Some national campaigns have included advice to breastfeed, in addition to recommendations on other risk factors, and the contribution of breastfeeding to the observed reduction in SIDS is unclear. The authors found no clinically important results from RCTs this systematic review, we present information relating to the effectiveness and safety of the following interventions: advice to avoid prone sleeping; advice to avoid tobacco-smoke exposure; advice to avoid soft sleeping surfaces; advice to avoid overheating or overwrapping; advice to avoid bed sharing; advice to breastfeed; advice to promote soother/pacifier use; and advice to promote room sharing (without bed sharing). We found no systematic review or RCTs studying the effects of interventions to reduce the risk of SIDS due to the obvious difficulties in performing these trials. Therefore, we report only observational
comparing advice to breastfeed with no advice and in some countries the incidence of SIDS had started to fall before the campaign started. The authors found no direct information on the effects of advice to promote soother/pacifier use in the prevention of SIDS The incidence of SIDS has also been reported to be higher in the siblings of infants who died from SIDS. *The first of these is an SR by Ip etal 2007 which was located in our search but excluded at FT due to their being a more recent SR on the same topic, covering similar set of papers. The is Mc Vea etal 2000 which would not have been evidence in this review. • Campaigns that have advised avoiding sleeping have significantly reduced the incidence of SIDS. Observational studies have additionally shown that the incidence of prone positioning is dramatically reduced after national advice campaigns. • Advice to avoid exposure seems to reduce the incidence of SIDS. National campaigns that advise mothers to avoid tobacco-smoke exposure also seem to lead to a reduction in maternal smoking rates. • Some campaigns included advice to overheating, overwrapping, and bed sharing, and advice to breastfeed, although it is not
captured by our search due to date of publication. clear whether this contributed to the observed reduction in SIDS. • We found no studies looking at the effects of advice to avoid soft sleeping surfaces, to promote soother/pacifier use, or to promote room sharing (without bed sharing). Study details Results of the study Main findings and evidence grading Education for mothers D'Halluin AR et al. 2011. Formative evaluation to improve prevention of sudden infant syndrome (SIDS): a prospective study. Acta Paediatr 100 (10): e147-e151 Study type: Randomised controlled trial. Formative evaluation Intervention: Information plus educative questionnaire on avoidable risk factors for SIDS. Description of Study took place in the maternity department of Rennes university hospital (France). All mothers usually hospitalised for 3 days post delivery. All received package of information on prevention of SIDS before discharge. Mothers in test condition received an educative questionnaire in addition. Questionnaire repeated (by telephone interview) 3 months after leaving hospital Quality of study: Suggests that all eligible mothers took part in the study but not explicitly stated. Follow up rates < 90% for both test and control groups. Control group less likely to be working class (assume based on occupational status – not explicit). Self report of compliance with SIDS prevention recommendations. Findings: Mothers’ scores at the educative questionnaire was 5.12 (1.52) [mean (standard deviation)]. The scores performed 3 months later were Intervention: Leaflet on avoidable risk factors for SIDS plus and educative questionnaire on The control group did not receive the educative questionnaire. Outcome: Knowledge of risk and protective factors for SIDS, compliance with SIDS prevention recommendation Evidence statement Grade B: This intervention is supported by evidence of effectiveness from a moderate quality single study Effect size: From a single randomised controlled knowledge of main SIDS risk factors (test vs control) AOR 1.69 (95% CI 1.02 to 2.77) p<0.01; indications
Intervention: Survey on pacifier use and knowledge of SIDS prevention followed by education intervention where a research assistant discussed SIDS prevention with caregivers by explaining the contents of a printed one page brochure Outcome: Pacifier use in children aged under six months Study Population: Caregivers of 780 babies under 12 months of age attending the emergency department in a county teaching hospital serving a mixed urban, suburban and rural population in California, USA. Date: Conducted between 26/11/2008 and 1/8/2011 Findings: Analyzed data for 780 infants. Parents knew of advice against co-sleeping in 469/780 (60%), smoking in 660/776 (85%), and prone sleeping in 613/780 (79%). Only 268/777 (35%) knew the recommendation to offer a pacifier at bedtime. At enrolment 449/780 (58%) did not use a pacifier. Of 210/338 infants aged less than 6 months followed up 41/112 (37%) non-users had started using a pacifier at bedtime (NNT 3). Over the same period, 37/98 (38%) users had discontinued their pacifier. Otitis media did not differ between users and non-users at 12 months. Evidence statement Grade D: It is not possible to draw a conclusion on the effectiveness of the intervention Author’s conclusions: Parental knowledge of the role of pacifiers in SIDS prevention was modest and much less than for other recommendations. Starting a pacifier prior to hospital discharge after birth was associated with greater use and lower discontinuation rates in the following year. Our broadly targeted ED-based educational intervention was labour intensive but appeared successful in increasing pacifier use. Pacifier use was not associated with increased otitis media. Comment: An uncontrolled before and after study is not a robust design for testing an intervention. The study design means that a causal link between the intervention and the increase in pacifier use cannot be established. Conducted in a single US state, predominantly single mother households may not generalise to UK/Wales setting. Impact of interventions on SIDS rate not addressed. Because of the rarity of this intervention the number needed to treat (NNT) to prevent one case of SIDS would be 8199
Interventions A (dark This intervention is supported by good quality evidence of its effectiveness NICE Recommended intervention/systematic review, of mostly good quality studies, with meta-analysis of majority of studies favouring intervention effect A (dark intervention is supported by evidence of its effectiveness from a good quality single study RCT with a very low risk of bias demonstrating positive effect B (light green): This intervention is supported by moderate quality evidence of its effectiveness Systematic review of moderate to good quality studies with majority, or demonstrating positive effect. NICE grade B recommendation. B (light green):This intervention is supported by evidence of its effectiveness from a moderate quality single study RCT with a low risk of bias demonstrating positive effect C (yellow): There is some evidence supporting the use of this intervention but it is not conclusive Systematic review of moderate to poor quality studies with majority, or meta - analysis favouring intervention or systematic review where studies may be of good quality and showing effect but the number of studies is too small to allow firm conclusions to be drawn C (yellow):There is some evidence from a poor quality single study supporting the use of this intervention but it is not conclusive RCT with a high risk of bias or well conducted cohort or case control study with a low risk of confounding, bias or chance, demonstrating positive effect D (orange): The evidence is inconsistent and it is not possible to draw a conclusion but there is some evidence of effect Systematic review with significant weakness and high risk of bias (positive results) or review of moderate quality with inconsistent findings in favour of the intervention D (orange):It is not possible to draw a conclusion on effectiveness of the intervention Single poor quality cohort or case control demonstrating positive effect E (bright orange): There is good evidence to suggest that this intervention has a sound theoretical basis or that work in this area is likely to have an impact but this has not been demonstrated in trials (this would apply particularly to pilot or novel interventions) Moderate to good quality systematic review of observational or qualitative studies or single observational (except cohort or case control) or qualitative study which suggest that the intervention addresses a significant risk factor or determinant of the behaviour of interest
F (blue): Expert opinion, formal consensus on experience not research evidence Recommended good practice based on clinical experience of an expert group e.g. NICE good practice recommendation G (pink): The evidence is inconsistent and it is not possible to draw a conclusion but it tends towards no effect Systematic review with studies judged as significant weak/risk of bias (evidence of no effect) or review of moderate quality studies with inconsistent findings in favour of no effect G (pink):It is not possible to draw a conclusion on effectiveness of the intervention Single poor quality cohort or case control study demonstrating negative effect H (red): is some evidence suggesting that this intervention is ineffective but it is not conclusive Systematic review of moderate to poor quality studies with majority favouring no effect H is evidence from a single study suggesting that this intervention is ineffective but it is not conclusive RCT with a high risk of bias or well conducted cohort or case control study with a low risk of confounding, bias or chance, demonstrating no effect I (dark red): There is moderate to good quality evidence that this intervention is unlikely to be effective Systematic review of moderate to good quality studies with majority in favour of control/no effect I (dark red):There is moderate to good evidence from a single study that this intervention is unlikely to be effective RCTs with a low risk of bias demonstrating no effect J (purple): There is high quality evidence of ineffectiveness or a specific recommendation that these interventions should not be introduced in the UK NICE specifically recommends this intervention should not be adopted or there is high quality review level evidence from meta-analysis of good quality studies that demonstrates no effect J (purple):There is high quality evidence of ineffectiveness from a single study RCT with a very low risk of bias demonstrating no effect K (grey): Evidence about the effectiveness of the intervention is lacking. Systematic review or NICE guidance which concludes that no reliable evidence of effectiveness of ineffectiveness, is available