Pacifiers and Sudden Infant Death Syndrome (SIDS):
A Selected Annotated Bibliography

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Jenik AG, Vain N.
The pacifier debate.
Early Hum Dev. 2009 Sep 16. [Epub ahead of print]

A variety of studies have indicated that pacifier use lowers the risk of SIDS. Many observational studies have demonstrated a negative association between pacifier use and breastfeeding duration. However, observational studies cannot be used to determine whether the pacifier is the real cause of breastfeeding cessation. Evidence for causation can be better supplied by randomised controlled trials (RCTs). Three RCTs have been conducted on the relationship between pacifiers and breastfeeding, but each study has limitations, implying that the evidence of not causal effect can be questionated. We have recently presented the results of a large RCT which demonstrated that in mothers who are successfully breastfeeding at 2 weeks, the recommendation to offer a pacifier does not modify the prevalence of exclusive and any breastfeeding at different ages or the duration of lactation. It is therefore important that lactation consultants and international agencies reexamine their staunch position to discourage the use of pacifiers on the basis of a supposed adverse effect on the success and duration of breastfeeding.

 

Hanzer M, Zotter H, Sauseng W, Pichler G, Müller W, Kerbl R.
Non-Nutritive Sucking Habits in Sleeping Infants.
Neonatology. 2009 Jul 31;97(1):61-66. [Epub ahead of print]

Background: Pacifier use has been postulated to decrease the risk of sudden infant death syndrome (SIDS). The responsible mechanisms are, however, unclear. Objectives: Since little is known about the non-nutritive sucking (NNS) habits of infants during sleep, we investigated NNS patterns and changes of physiological parameters during NNS in sleeping infants. Methods: Polygraphic recordings were performed in 12 infants with a median age of 55 days (range 7-82) who regularly used a pacifier during sleep. Episodes of active suckling (bursts) and quiescent periods were differentiated by video observations. We evaluated the time of suckling in relation to the total time of pacifier use, the median number of bursts per min, the median duration of single bursts and the median interval between 2 sequent bursts. In 48 randomly selected bursts, we additionally analyzed changes in heart rate, respiratory frequency and oxygen saturation compared to the 10-second period preceding the burst. Results: Median sleep time with a pacifier held in mouth was 31.3 min (13.0-117.6), of which 15.5% (6.4-36.7%) was spent with active suckling. The median number of bursts per min was 2.2 (1.2-4.5). The median duration of a burst was 3 s (1-22) and the median interval between 2 bursts was 10 s (1-1,434). Heart rate, respiratory frequency and oxygen saturation did not change significantly during suckling bursts. Conclusions: This pilot study presents important data for sucking habits in pacifier users which may provide a basis for further investigations concerning the efficacy of pacifiers in SIDS prophylaxis. Copyright © 2009 S. Karger AG, Basel.

 

Jenik AG, Vain NE, Gorestein AN, Jacobi NE; Pacifier and Breastfeeding Trial Group.Collaborators (11)
Lopez N, Rossato N, Corral G, Russo S, Degregori MC, Covas MC, Ventura S, Rodríguez S, Fariña D, Bergel E, Abadie P.
Does the recommendation to use a pacifier influence the prevalence of breastfeeding?
J Pediatr. 2009 Sep;155(3):350-4.e1. Epub 2009 May 21.

OBJECTIVE: To evaluate whether the recommendation to offer a pacifier once lactation is well established reduces the prevalence or duration of breastfeeding. STUDY DESIGN: A multicenter, randomized, non-inferiority, controlled trial comprising 1021 mothers highly motivated to breastfeed whose newborns regained birth weight by 15 days. They were assigned to offer versus not to offer pacifiers. Primary outcome was prevalence of exclusive breastfeeding at 3 months. Main secondary outcomes were the prevalence of exclusive and any breastfeeding at different ages and duration of any breastfeeding. RESULTS: At 3 months, 85.8% infants in the offer pacifier group and 86.2% in the not offer pacifier group were exclusively breastfeeding (risk difference, 0.4%; 95% CI, -4.9%-4.1%), satisfying the pre-specified non-inferiority requirement of -7%. Furthermore, the recommendation to offer a pacifier did not produce a significant decrease in the frequency of exclusive and any breastfeeding at different ages or in the duration of lactation. CONCLUSIONS: The recommendation to offer a pacifier at 15 days does not modify the prevalence and duration of breastfeeding. Because pacifier use is associated with reduced incidence of sudden infant death syndrome, the recommendation to offer a pacifier appears safe and appropriate in similar populations.

 

Sexton S, Natale R.
Risks and benefits of pacifiers.
Am Fam Physician. 2009 Apr 15;79(8):681-5.

Physicians are often asked for guidance about pacifier use in children, especially regarding the benefits and risks, and when to appropriately wean a child. The benefits of pacifier use include analgesic effects, shorter hospital stays for preterm infants, and a reduction in the risk of sudden infant death syndrome. Pacifiers have been studied and recommended for pain relief in newborns and infants undergoing common, minor procedures in the emergency department (e.g., heel sticks, immunizations, venipuncture). The American Academy of Pediatrics recommends that parents consider offering pacifiers to infants one month and older at the onset of sleep to reduce the risk of sudden infant death syndrome. Potential complications of pacifier use, particularly with prolonged use, include a negative effect on breastfeeding, dental malocclusion, and otitis media. Adverse dental effects can be evident after two years of age, but mainly after four years. The American Academy of Family Physicians recommends that mothers be educated about pacifier use in the immediate postpartum period to avoid difficulties with breastfeeding. The American Academy of Pediatrics and the American Academy of Family Physicians recommend weaning children from pacifiers in the second six months of life to prevent otitis media. Pacifier use should not be actively discouraged and may be especially beneficial in the first six months of life.

 

Vennemann MM, Bajanowski T, Brinkmann B, Jorch G, Sauerland C, Mitchell EA; GeSID Study Group.Collaborators (26)
Bach P, Bockholt B, Bohnert M, Cremer U, Deml U, Freislederer A, Heide S, Huckenbeck W, Jachau K, Kaatsch HJ, Klein A, Kleemann WJ, Larsch KP, Fiegut A, Fischer D, Leukel W, Rauch E, Paulus W, Penning R, Rublack F, Sauerland C, Schlaud M, Schmidt B, Sperhake J, Zimmer G, Zweihoff R.
Sleep environment risk factors for sudden infant death syndrome: the German Sudden Infant Death Syndrome Study.
Pediatrics. 2009 Apr;123(4):1162-70.

OBJECTIVE: Our goal was to investigate the risk factors for sudden infant death syndrome in the infants' sleep environment for a population in which few infants sleep prone as a result of education campaigns. METHODS: This was a population-based sudden infant death syndrome case-control study over 3 years (1998-2001) in Germany. RESULTS: There were 333 sudden infant death syndrome cases and 998 matched controls. Although only 4.1% of the infants were placed prone to sleep, those infants were at a high risk of sudden infant death syndrome. Those who were unaccustomed to sleeping prone were at very high risk, as were those who turned to prone. Bed sharing (especially for infants younger than 13 weeks); duvets; sleeping prone on a sheepskin; sleeping in the house of a friend or a relative (compared with sleeping in the parental home); and sleeping in the living room (compared with sleeping in the parental bedroom) increased the risk for sudden infant death syndrome; pacifier use during the last sleep was associated with a significantly reduced risk of sudden infant death syndrome. CONCLUSIONS: This study has clarified the risk factors for sudden infant death syndrome in a population where few infants sleep prone. This study supports the current recommendations of the American Academy of Pediatrics. This study has identified several novel risk factors for sudden infant death syndrome: an increased risk if the infants sleeps outside the parental home, death in the living room, and the high risk when sleeping prone on a sheepskin; however, because the numbers of cases in these groups are small, additional studies are needed to confirm these findings.

Hanzer M, Zotter H, Sauseng W, Pfurtscheller K, Müller W, Kerbl R.
Pacifier use does not alter the frequency or duration of spontaneous arousals in sleeping infants.
Sleep Med. 2009 Apr;10(4):464-70. Epub 2008 Aug 5.

OBJECTIVE: It has been reported that pacifiers might reduce the risk of SIDS by favouring infants' arousability from sleep. We evaluated the influence of a pacifier on the frequency and duration of spontaneous arousals in healthy infants. METHODS: Polygraphic recordings were performed in 14 infants with an age of 51.7+/-19.9 days (means+/-SD) who regularly used a pacifier during sleep. Cortical and subcortical arousals were scored according to the recommendations of the "International Paediatric Work Group on Arousals." The number of arousals per 10-min-period and the duration of arousals were determined for periods of pacifier use as well as for periods after pacifier dislodgement and were compared with the data of 10 control infants (age 49.8+/-16.5 days) who never used a pacifier. RESULTS: Altogether, 211 arousals in pacifier users and 225 arousals in non-users were scored. In pacifier users, 2.0+/-1.6 arousals per 10-min-period with a duration of 12.2+/-3.0 s occurred during pacifier use, and 1.7+/-1.6 arousals per 10-min-period with a duration of 12.2+/-3.1s occurred during periods without pacifier. In pacifier non-users, 2.3+/-1.2 arousals per 10-min-period (duration 13.9+/-2.9s) were scored. The results did not show a significant difference concerning frequency and duration of spontaneous arousals between pacifier users and non-users. CONCLUSIONS: Our findings suggest that factors other than arousal mechanisms might be responsible for the efficacy of pacifiers in SIDS prophylaxis.

Tonkin SL, Vogel SA, Gunn AJ.
Upper airway size while sucking on a pacifier in an infant with micrognathia.
J Paediatr Child Health. 2008 Jan;44(1-2):78-9.

In an infant with micrognathia, who was being evaluated after an apparent life-threatening event, respiration timed lateral radiographs showed an increase in the width of the middle airway space during inspiration from 2 mm without the pacifier to 9 mm while sucking on a pacifier. This observation is consistent with the hypothesis that the well-documented association between the pacifier use and reduced risk of sudden infant death syndrome may be at least in part related to changes in airway size.

Marter A, Agruss JC.
Pacifiers: an update on use and misuse.
J Spec Pediatr Nurs. 2007 Oct;12(4):278-85.

PURPOSE: The use of pacifiers is a controversial topic; this article looks at the subject from both a historical and cultural perspective, with a review of current research. CONCLUSIONS: The use of pacifiers in infants older than 1 month is currently recommended by multiple researchers to prevent sudden infant death syndrome, and is associated with other benefits for premature infants. However, pacifier use has also been associated with higher risk of otitis media. PRACTICE IMPLICATIONS: Knowledge of the most recent evidence will enable providers to communicate appropriate guidelines on pacifier use to families.

 

Damato EG.
Safe sleep: can pacifiers reduce SIDS risk?
Nurs Womens Health. 2007 Feb;11(1):72-6.

Comment in: Nurs Womens Health. 2007 Aug;11(4):355; author reply 355-6.

In November 2005, the American Academy of Pediatrics (AAP) Task Force on Sudden Infant Death Syndrome (SIDS) (2005) released updated recommendations regarding sleep environment modifications aimed at reducing the risk of SIDS. Probably, the most controversial part of the updated guidelines involves the recommendation to offer a pacifier at nap time and bedtime to infants through the first year of life. To help nurses counsel new parents on infant care practices, this article presents a review of what's known about SIDS and about how pacifiers are believed to affect risk, and a discussion of the strengths and limitations of the research findings and of potential disadvantages related to pacifier use.

 

Soxman JA.
Non-nutritive sucking with a pacifier: pros and cons.
Gen Dent. 2007 Jan-Feb;55(1):59-62; quiz 63, 79-80.

The detrimental effects of prolonged pacifier use on the developing oral structures are often the primary focus of dental professionals; however, non-nutritive sucking with a pacifier has other consequences that include not only harmful effect but positive influences as well. This article will address some of the issues for consideration regarding the use of pacifiers and provide information for appropriate recommendations to parents of infants and toddlers regarding the use and cessation of non-nutritive sucking with a pacifier.

 

Tonkin SL, Lui D, McIntosh CG, Rowley S, Knight DB, Gunn AJ.
Effect of pacifier use on mandibular position in preterm infants.
Acta Paediatr. 2007 Aug 20; [Epub ahead of print].

Aim: It has been hypothesized that the association of pacifier use with reduced risk of sudden infant death is mediated by forward movement of the mandible and tongue that helps open the upper airway. Our aim was to examine whether the mandible is moved forward when an infant is sucking on a pacifier, and if so, whether the mandible remains advanced after the pacifier is removed. Methods: In sixty clinically stable premature infants (corrected gestation age 36.5 +/- 0.3 weeks, mean +/- SEM) the distance from each ear where the pinna met the cheek to the most prominent point of the chin was measured bilaterally, and the average was used as an index of mandibular position. Mandibular position was determined before and after allowing the infants to suck on a pacifier for 10-15 min, and after removing the pacifier. Results: There was a significant forward movement of the mandible when the infants were sucking on the pacifier (59.5 +/- 0.7 vs. 58.6 +/- 0.7 mm, p = 0.001), with no significant change after the pacifier was removed. Conclusions: Pacifier use in preterm infants was associated with a small significant forward displacement of the jaw. These data suggest that pacifier use may help protect the upper airway.

 

Comina E, Marion K, Renaud FN, Dore J, Bergeron E, Freney J.
Pacifiers: A microbial reservoir.
Nurs Health Sci. 2006 Dec; 8(4):216-23.

The permanent contact between the nipple part of pacifiers and the oral microflora offers ideal conditions for the development of biofilms. This study assessed the microbial contamination on the surface of 25 used pacifier nipples provided by day-care centers. Nine were made of silicone and 16 were made of latex. The biofilm was quantified using direct staining and microscopic observations followed by scraping and microorganism counting. The presence of a biofilm was confirmed on 80% of the pacifier nipples studied. This biofilm was mature for 36% of them. Latex pacifier nipples were more contaminated than silicone ones. The two main genera isolated were Staphylococcus and Candida. Our results confirm that nipples can be seen as potential reservoirs of infections. However, pacifiers do have some advantages; in particular, the potential protection they afford against sudden infant death syndrome. Strict rules of hygiene and an efficient antibiofilm cleaning protocol should be established to answer the worries of parents concerning the safety of pacifiers.

 

Thompson JM, Thach BT, Becroft DM, Mitchell EA
Sudden infant death syndrome: Risk factors for infants found face down differ from other SIDS cases.
J Pediatr. 2006 Nov;149(5):630-633.

OBJECTIVE: To test the hypothesis that infants with sudden infant death syndrome (SIDS) found face down (FD) would have SIDS risk factors different from those found in other positions (non-face-down position, NFD). STUDY DESIGN: We used the New Zealand Cot Death Study data, a 3-year, nationwide (1987 to 1990), case-control study. Odds ratios (univariate and multivariate) for FD (n = 154) and NFD SIDS (n = 239) were estimated separately, and statistical differences between the two groups were assessed. RESULTS: Of 12 risk factors for SIDS, there were 8 with a statistically significant difference between FD and NFD infants. After adjustment for the potential confounders, younger infant age, Maori ethnicity, low birth weight, prone sleep position, use of a sheepskin, and pillow use were all associated with a greater risk of SIDS in the FD than the NFD group. Sleeping during the nighttime, maternal smoking, and bed-sharing were associated with a risk of SIDS only in the NFD group. Pacifier use was associated with a decreased risk for SIDS only in the NFD group, whereas being found with the head covered was associated with a decreased risk for SIDS for the FD group. CONCLUSIONS: Infants with SIDS in the FD position appear to be a distinct subgroup of SIDS. These differences in risk factors provide clues to mechanisms of death in both SIDS subtypes.

 

Joanna Briggs Institute
Early childhood pacifier use in relation to breastfeeding, SIDS, infection and dental malocclusion.
Nurs Stand. 2006 May 31-Jun 6; 20(38):52-5.

This information on best practice is based on a systematic review (Callaghan et al 2005) conducted by the Institute Nurses' Network (Telethon Institute of Child Health Research), Western Australian community and child health nurses and the Western Australian Centre for Evidence Based Nursing and Midwifery, a collaborating centre of the Joanna Briggs Institute. The primary references on which this information is based are available online via Blackwell Synergy: http://www.blackwell-synergy.com and to members of the institute via the web site: http://www.joannabriggs.edu.au

 

Li DK, Willinger M, Petitti DB, Odouli R, Liu L, Hoffman HJ.
Use of a dummy (pacifier) during sleep and risk of sudden infant death syndrome (SIDS): population based case-control study.
BMJ. 2006 Jan 7; 332(7532):18-22. E-pub 2005 Dec 9.

Objectives: To examine the association between use of a dummy (pacifier) during sleep and the risk of sudden infant death syndrome (SIDS) in relation to other risk factors. Design: Population based case-control study. Setting: Eleven counties in California. Participants: Mothers or carers of 185 infants whose deaths were attributed to SIDS and 312 randomly selected controls matched for race or ethnicity and age. Main outcome Measures: Use of a dummy during sleep determined through interviews. Results: The adjusted odds ratio for SIDS associated with using a dummy during the last sleep was 0.08 (95% confidence interval 0.03 to 0.21). Use was associated with a reduction in risk in every category of sociodemographic 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 may reduce the impact of other risk factors for SIDS, especially those related to adverse sleep environment. For example, infants who did not use a dummy and slept prone or on their sides (v on their back) had an increased risk of SIDS (2.61, 1.56 to 4.38). In infants who used dummies, there was no increased risk associated with sleeping position (0.66, 0.12 to 3.59). While cosleeping with a mother who smoked was also associated with increased risk of SIDS among infants who did not use a dummy (4.5, 1.3 to 15.1), there was no such association among those who did (1.1, 0.1 to 13.4). 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.

 

American Academy of Pediatrics Task Force on Sudden Infant Death Syndrome
The changing concept of sudden infant death syndrome: Diagnostic coding shifts, controversies regarding the sleeping environment, and new variables to consider in reducing risk.
Pediatrics. 2005 Nov; 116(5):1245-55. E-pub 2005 Oct 10.

There has been a major decrease in the incidence of sudden infant death syndrome (SIDS) since the American Academy of Pediatrics (AAP) released its recommendation in 1992 that infants be placed down for sleep in a non prone position. Although the SIDS rate continues to fall, some of the recent decrease of the last several years may be a result of coding shifts to other causes of unexpected infant deaths. Since the AAP published its last statement on SIDS in 2000, several issues have become relevant, including the significant risk of side sleeping position; the AAP no longer recognizes side sleeping as a reasonable alternative to fully supine sleeping. The AAP also stresses the need to avoid redundant soft bedding and soft objects in the infant's sleeping environment, the hazards of adults sleeping with an infant in the same bed, the SIDS risk reduction associated with having infants sleep in the same room as adults and with using pacifiers at the time of sleep, the importance of educating secondary caregivers and neonatology practitioners on the importance of "back to sleep," and strategies to reduce the incidence of positional plagiocephaly associated with supine positioning. This statement reviews the evidence associated with these and other SIDS-related issues and proposes new recommendations for further reducing SIDS risk.

 

Hauck FR, Omojokun OO, Siadaty MS.
Do pacifiers reduce the risk of sudden infant death syndrome? A meta-analysis.
Pediatrics. 2005 Nov; 116(5):e716-23. E-pub 2005 Oct 10.

Objective: Pacifier use has been reported to be associated with a reduced risk of sudden infant death syndrome (SIDS), but most countries around the world, including the United States, have been reluctant to recommend the use of pacifiers because of concerns about possible adverse effects. This meta-analysis was undertaken to quantify and evaluate the protective effect of pacifiers against SIDS and to make a recommendation on the use of pacifiers to prevent SIDS. Methods: We searched the Medline database (January 1966 to May 2004) to collect data on pacifier use and its association with SIDS, morbidity, or other adverse effects. The search strategy included published articles in English with the Medical Subject Headings terms "sudden infant death syndrome" and "pacifier" and the keywords "dummy" and "soother." Combining searches resulted in 384 abstracts, which were all read and evaluated for inclusion. For the meta-analysis, articles with data on the relationship between pacifier use and SIDS risk were limited to published original case-control studies, because no prospective observational reports were found; 9 articles met these criteria. Two independent reviewers evaluated each study on the basis of the 6 criteria developed by the American Academy of Pediatrics Task Force on Infant Positioning and SIDS; in cases of disagreement, a third reviewer evaluated the study, and a consensus opinion was reached. We developed a script to calculate the summary odds ratio (SOR) by using the reported ORs and respective confidence intervals (CI) to weight the ORs. We then pooled them together to compute the SOR. We performed the Breslow-Day test for homogeneity of ORs, Cochran-Mantel-Haenszel test for the null hypothesis of no effect (OR = 1), and the Mantel-Haenszel common OR estimate. The consistency of findings was evaluated and the overall potential benefits of pacifier use were weighed against the potential risks. Our recommendation is based on the taxonomy of the 5-point (A-E) scale adopted by the US Preventive Services Task Force. Results: Seven studies were included in the meta-analysis. The SOR calculated for usual pacifier use (with univariate ORs) is 0.90 (95% confidence interval [CI]: 0.79-1.03) and 0.71 (95% CI: 0.59-0.85) 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. Conclusions: Published case-control 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: 2416-3334) 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 analysis. Therefore, we recommend that pacifiers be offered to infants as a potential method to reduce the risk of SIDS. The pacifier should be offered to the infant when being placed for all sleep episodes, including daytime naps and nighttime 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.

 

Nelson EA, Yu LM, Williams S; International Child Care Practices Study Group Members.
International Child Care Practices study: Breastfeeding and pacifier use.
J Hum Lact. 2005 Aug; 21(3):289-95.

Although the Baby-Friendly Hospital Initiative advises that no pacifiers be given to breastfeeding infants, both breastfeeding and pacifier use may protect against sudden infant death syndrome. The International Child Care Practice Study data set on child care practices associated with sudden infant death syndrome risk from 21 centers in 17 countries was used to describe infant-feeding practices and pacifier use and assess factors associated with breastfeeding. At approximately 3 months of age, rates of breastfeeding only (4%-80%) and pacifier use (12.5%-71%) varied between centers. Pacifier use was negatively associated with breastfeeding, and a dose-response effect was noted. Other negative (multiple birth, smoking by mother) and positive (intention to breastfeed, bed sharing, mothers' education) associations with breastfeeding only were identified. Although causality should not be inferred, these associations are consistent with previous studies. Advice on pacifiers should include potential benefits as well as risks.

September 2009

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