Drivers of decision-making regarding infant sleep practices among mothers with opioid use disorder.

OBJECTIVE: To understand the perspectives and perceived facilitators of and barriers to following safe infant sleeping practices among mothers with opioid use disorder (OUD). STUDY DESIGN: Using the Theory of Planned Behavior (TPB) framework, we conducted qualitative interviews with mothers with OUD regarding infant sleep practices. We created codes and generated themes, concluding data collection upon achieving thematic saturation. RESULTS: Twenty-three mothers with infants 1-7 months of age were interviewed from 08/2020 to 10/2021. Mothers chose sleeping practices they perceived made their infants safer, more comfortable, and minimized infant withdrawal symptoms. Mothers in residential treatment facilities were influenced by facility infant sleep rules. Hospital sleep modeling and varied advice by providers, friends and family influenced maternal decisions. CONCLUSIONS: Mothers reported factors unique to their experience with OUD that influenced their decisions about infant sleep that should be considered when developing tailored interventions to promote safe infant sleep in this population.

Understanding cigarette smoking among mothers with opioid use disorder.

BACKGROUND: Cigarette smoking is highly prevalent among mothers with opioid use disorder (OUD). Organizations such as the American College of Obstetrics and Gynecology recommend cessation of cigarettes during the pre- and postnatal periods. Factors that inform decisions to continue or stop smoking cigarettes among pregnant and postpartum mothers with OUD are unclear. AIMS: This study aimed to understand (1) the lived experience of mothers with OUD regarding cigarette smoking and (2) barriers and facilitators to reduction of cigarette smoking during the pre- and postnatal periods. METHODS: Guided by the Theory of Planned Behavior (TPB) framework, we completed semi-structured, in-depth interviews with mothers with OUD with infants 2-7 months of age. We used an iterative approach to analysis by conducting interviews and developing and revising codes and themes until we reached thematic saturation. RESULTS: Fifteen of 23 mothers reported smoking cigarettes prenatally and postnatally, 6 of 23 smoked cigarettes during the prenatal period only, and 2 mothers were non-smokers. We found that mothers: 1) believed that smoke exposure had negative health consequences and may exacerbate withdrawal symptoms for their infants; 2) implemented risk mitigation practices, which were dictated both by themselves and by outside rules, to reduce the harmful effects of smoke around infants; 3) were motivated to quit or cut-down on smoking because of the desire to optimize the health and well-being of their infants; 4) continued to smoke because they felt that the stress related to caregiving and their own recovery were a higher priority than quitting smoking; and 5) were influenced by exposure to smokers with whom they lived, as well as by the varied advice of medical providers, family, and friends. CONCLUSION: While mothers with OUD acknowledged the negative health impact of cigarette smoke exposure to their infants, many experienced stressors related to recovery and caregiving unique to those with OUD that impacted their cigarette smoking behaviors.

Understanding and Addressing Bias in Grading: Progress at Washington University School of Medicine.

In 2020, the authors published work examining disparities in clerkship grading and found students who identify as White were more likely to receive honors grades compared with students from races/ethnicities traditionally underrepresented in medicine. Through a quality improvement approach, the authors identified the following 6 areas where improvements could mitigate grading disparities and, therefore, put processes in place to: ensure equitable access to examination preparation resources, change student assessment, develop medical student curriculum interventions, improve the learning environment, change house staff and faculty recruitment and retention practices, and provide ongoing program evaluation and continuous quality improvement processes to monitor for success. While the authors cannot yet be sure that they have achieved their goal of promoting equity in grading, they believe this evidence-based, multipronged intervention is a clear step in the right direction and encourage other schools to consider a similar approach to tackling this critically important problem at their own institutions.

Student and Teacher Perspectives on Equity in Clinical Feedback: A Qualitative Study Using a Critical Race Theory Lens.

PURPOSE: The authors aimed to gain a better understanding of students' and teachers' perspectives about whether clinical clerkship feedback is provided equitably irrespective of a student's race/ethnicity. METHOD: A secondary analysis of existing interview data was conducted, focusing on racial/ethnic disparities in clinical grading. Data had been acquired from 29 students and 30 teachers at 3 U.S. medical schools. The authors performed secondary coding on all 59 transcripts, writing memos focused on statements related to aspects of feedback equity and developing a template for coding students' and teachers' observations and descriptions specific to clinical feedback. Using the template, memos were coded, and thematic categories emerged describing perspectives on clinical feedback. RESULTS: Forty-eight (22 teachers and 26 students) participants' transcripts provided narratives about feedback. Both student and teacher narratives described how students who are racially/ethnically underrepresented in medicine may receive less helpful formative clinical feedback needed for professional development. Thematic analysis of narratives yielded 3 themes related to feedback inequities: 1) teachers' racial/ethnic biases influence the feedback they provide students, 2) teachers have limited skill sets to provide equitable feedback, and 3) racial/ethnic inequities in the clinical learning environment shape clinical and feedback experiences. CONCLUSIONS: Narratives indicated that both students and teachers perceived racial/ethnic inequities in clinical feedback. Teacher- and learning environment-related factors influenced these racial/ethnic inequities. These results can inform medical education's efforts to mitigate biases in the learning environment and provide equitable feedback to ensure every student has what they need to develop into the competent physician they aspire to be.

Perspectives about Environmental Tobacco Smoke Exposure from Mothers of Premature Infants.

OBJECTIVE: The study aimed to better understand the perceptions of mothers of preterm infants regarding smoking behaviors and environmental tobacco smoke (ETS) exposure using qualitative methodology. STUDY DESIGN: Using a Grounded Theory approach, we conducted in-depth, semi-structured interviews with mothers of preterm infants, both smokers and nonsmokers. Using the Theory of Planned Behavior (TPB) as a conceptual framework for our questions, we conducted and analyzed interviews until theoretical saturation was reached. Analysis included an iterative coding process resulting in theme development. RESULTS: Our key themes aligned with the TPB domains of attitudes, perceived control, and social norms. Regarding attitudes, mothers expressed that smoking was bad for their infants and that preterm infants were more vulnerable than term infants. Regarding perceived control, mothers commented on their perceived ability to avoid ETS exposure with subthemes including strategies utilized to mitigate ETS exposure risk. Some mothers expressed difficulty avoiding ETS exposure, for example, when residing in high-density housing. Regarding perceived social norms, mothers whose family and friends were nonsmokers expressed ease avoiding ETS, while mothers whose family and friends were smokers expressed more difficulty avoiding ETS. CONCLUSION: Mothers used a variety of behaviors within the domains of the TPB to reduce ETS exposures in their preterm infants which can inform future neonatal intensive care unit-based interventional strategies. KEY POINTS: · Mothers felt ETS is harmful for preterm infants.. · Mothers reported strategies for ETS avoidance.. · Mothers reported barriers to ETS avoidance.. · TPB can frame mothers' ETS-related behaviors..

Racial and Ethnic Disparities in Breastfeeding Continuation Among U.S. Hispanic Mothers: Identification of Mechanisms.

Objective: We examined the extent to which social, maternal, and infant factors and Theory of Planned Behavior (TPB) domains-attitudes, perceived control, and subjective norms-mediate the relationship between maternal race and ethnicity and birth country, and breastfeeding continuation. Materials and Methods: A nationally representative cohort of 2,810 mothers with self-reported race, ethnicity, and birth country was used. Main outcomes included any and exclusive breastfeeding at 2-6 months of infant age. A conceptual framework with the aforementioned mediators of interest was developed. Logistic regression was used to examine main associations, and structural equation modeling was used to identify the extent to which proposed mediators explained the relationship between independent and dependent variables. Results: One thousand two hundred twenty-one mothers were U.S.-born non-Hispanic white (NHW), 432 U.S.-born Hispanic, 329 Mexico-born Hispanic, 107 Central- or South America-born Hispanic, 33 Caribbean-born Hispanic, and 688 U.S.-born non-Hispanic black (NHB). No differences in breastfeeding continuation among U.S.-born NHW and U.S.-born Hispanic mothers were found. In contrast, compared with U.S.-born NHW mothers, Mexico-born (odds ratio [OR] 1.99, 95% confidence interval [CI] 1.46-2.72) and Central- or South America-born (OR 3.42, 95% CI 1.89-6.17) Hispanic mothers had higher odds, and Caribbean-born Hispanic mothers had lower odds (OR 0.45, 95% CI 0.26-0.76) of any breastfeeding. These relationships were mediated by attitudes and subjective norms. Conclusions: Breastfeeding continuation among U.S. Hispanic mothers varied by birth country, highlighting the heterogeneity of breastfeeding populations of Hispanic mothers in the United States. Tailored interventions should strengthen policies supportive of positive attitudes toward and subjective norms around breastfeeding.

Racism and Quality of Neonatal Intensive Care: Voices of Black Mothers.

BACKGROUND AND OBJECTIVES: Black preterm infants are more likely to die than White preterm infants within the same NICU. Racism may lead to disparate quality of NICU care contributing to disparities in preterm infant health outcomes. The objective of our study was to understand Black mothers' perspectives of the impact of racism on the quality of care for Black preterm infants in the NICU and what might be done to address it. METHODS: Using qualitative research methods, we conducted in-depth, semistructured interviews with 20 Black mothers of preterm infants in a single Level IV NICU 6 to 18 months after hospital discharge regarding experiences with disparate quality of NICU care. We developed themes iteratively and conducted interviews until thematic saturation was reached. RESULTS: The majority of mothers believed that racism impacted the quality of NICU care and described examples of racism in the NICU at structural, institutional, and interpersonal levels. Mothers also provided ideas for interventions that would decrease racism and improve quality of NICU care for Black families, including increased Black representation, increased peer support, and improved staff education and training. CONCLUSIONS: Black mothers of preterm infants experienced racism during NICU hospitalization that impacted the quality of care they received. Interventional studies directed toward mitigating these racial disparities may focus on addressing racism during the NICU period and should include input from Black stakeholders at all stages of design, implementation, and analysis.

Racial/Ethnic Disparities in Clerkship Grading: Perspectives of Students and Teachers.

PURPOSE: Racial/ethnic disparities exist in clinical clerkship grading, yet little is known about medical student and faculty perspectives on why these disparities occur. This study explored what happens during clerkships that might explain grading disparities. METHOD: Medical students and clerkship teachers at 3 U.S. medical schools completed a demographic survey and semistructured interview. The constant comparative method was used to analyze transcripts by inductively developing codes; grouping codes in categories; and refining codes, descriptions, and group assignments to identify themes. Interpretations of and relationships among themes were iteratively discussed to develop a grounded theory. RESULTS: Fifty-nine participants (29 medical students, 30 teachers [28 clinical faculty, 2 residents]) were interviewed in 2020. The Social Milieu of Medical Education (relationships, fit, opportunities, and judgments in the clinical-learning setting) was the organizing theme, influenced by 5 additional themes: Societal Influence (experiences in society), Students' Characteristics and Background (personal characteristics and experiences outside medical school), Assessment Processes (collection of student performance data and how data inform grades), Learning Environment (resources available and messaging within the clinical setting), and Students' Interactions and Reactions (interactions with and reactions to peers and teachers). The grounded theory highlights complex, multilayered aspects of how the social milieu of medical education is shaped by and shapes students' experiences, relationships, and clerkship assessments and promotes clerkship-grading disparities. CONCLUSIONS: Mitigating clerkship-grading disparities will require intervening on interrelated, contextual factors to provide equitable opportunities for students from diverse backgrounds and with varying styles of engagement in clinical-learning settings, along with attending to modifying assessment processes.

Lived experiences of stress of Black and Hispanic mothers during hospitalization of preterm infants in neonatal intensive care units.

OBJECTIVE: To characterize the lived experiences of stress associated with having a preterm infant hospitalized in the NICU among Black and Hispanic mothers. METHODS: We performed a qualitative content analysis of secondary data from two prior studies that included 39 in-depth interviews with Black and Hispanic mothers of preterm infants at 3 U.S. NICUs. We used a constant comparative method to select important concepts and to develop codes and subsequent themes. RESULTS: Black and Hispanic mothers described stressors in the following domains and categories: Individual (feeling overwhelmed, postpartum medical complications, previous stressful life events, competing priorities); Hospital (perceived poor quality of care, provider communication issues, logistical issues); Community (lack of social supports, lack of financial resources, work challenges). CONCLUSIONS: The findings of this study suggest that stressors both inside and outside of the hospital affect the lived experiences of stress by Black and Hispanic mothers during NICU hospitalization.

Disparities in Breastfeeding Among U.S. Black Mothers: Identification of Mechanisms.

Objective: Disparities in U.S. breastfeeding rates persist among Black mothers according to birth country and between Black and White mothers, necessitating further investigation of modifiable mediating factors to inform interventions. This study seeks to examine the extent that social, maternal, infant factors and Theory of Planned Behavior (TPB) domains (attitudes, perceived control, and subjective norms) mediate the association of maternal race/birth country and breastfeeding continuation. Methods: A national cohort of 2,050 mothers self-identifying as U.S.-born non-Hispanic Black (n = 689), foreign-born non-Hispanic Black (n = 139), and U.S.-born non-Hispanic White (n = 1,222) was analyzed. Using logistic regression, associations of race/birth country and any/exclusive breastfeeding at 2-6 months were examined. Structural equation modeling was used to determine whether social, maternal, and infant factors and TPB domains mediate these relationships. Results: 40.0% of U.S.-born Black, 82.2% of foreign-born Black, and 57.3% of U.S.-born White mothers reported any breastfeeding at 2-6 months. Compared with U.S.-born Black mothers, odds of any breastfeeding were sevenfold higher among foreign-born Black mothers (odds ratio [OR] = 7.04 95% confidence interval [CI] = 4.80-10.31), which was explained partly by social/maternal/infant factors and TPB domains. Compared with U.S.-born White mothers, any breastfeeding was lower (OR = 0.54, 95% CI = 0.40-0.73) among U.S.-born Black mothers and higher (OR = 3.81, 95% CI = 2.48-5.87) among foreign-born Black mothers; these differences were also mediated by the aforementioned factors. Conclusions: Among Black mothers in the United States, breastfeeding continuation varied substantially by birth country. Promotion of interventions targeting positive attitudes, perceived control, and subjective norms may reduce disparities among Black and between Black and White mothers.

Understanding the barriers and facilitators to safe infant sleep for mothers of preterm infants.

OBJECTIVE: To identify barriers and facilitators to adherence to safe sleep practices (SSP) among mothers of preterm infants using qualitative methodology. DESIGN: We conducted 23 in-depth interviews in English or Spanish with mothers of preterm infants who were recently discharged from four hospitals, utilizing a grounded-theory approach and framework of the Theory of Planned Behavior (attitudes, perceived control, social norms). RESULTS: For attitudes, mothers' fear about their infants' vulnerable preterm state related to suffocation, apnea of prematurity, and reflux influenced infant sleep practices. For social norms, education received in the NICU and advice from other health care providers, family, friends, and media impacted their choices. For perceived control, mothers adapted infant sleep practices to meet their own needs and address the perceived safety and comfort of infants. CONCLUSION: Factors identified that influence maternal decision-making about infant sleep practices can inform interventions to address sudden unexpected infant death reduction in preterm infants.

Washington University School of Medicine in St. Louis Case Study: A Process for Understanding and Addressing Bias in Clerkship Grading.

In 2018, in response to a news story featuring the Icahn School of Medicine's decision to eliminate its chapter of Alpha Omega Alpha (AOA) due to perceived racial inequities, students at Washington University School of Medicine in St. Louis (WUSM) brought similar concerns to leadership. WUSM leadership evaluated whether students' race, ethnicity, and gender were associated with their receipt of honors in the 6 core clerkships, key determinants of AOA selection. In preliminary analysis of the school's data, statistically significant racial and ethnic disparities were associated with receipt of honors in each clerkship. Leaders shared these findings with the WUSM community along with a clear message that such discrepancies are unacceptable to the school. An effort to further analyze what lay behind the findings as well as to identify steps to resolve the problem was launched. Using a quality improvement framework, data from focus groups and student surveys were analyzed and 2 overarching themes emerged. Students perceived that both assessment and the learning environment impacted racial/ethnic disparities in clerkship grades. In multivariable logistic regression models, shelf exam scores (a part of student assessment) were found to be associated with receipt of honors in each clerkship; in some (but not all) clerkships, shelf exam scores attenuated the effect of race/ethnicity on receipt of honors, so that when the shelf scores were added to the model, the race/ethnicity effect was no longer significant. This case study describes WUSM's process to understand and address bias in clerkship grading and AOA nomination so that other medical schools might benefit from what has been learned.

Use of the Theory of Planned Behavior Framework to Understand Breastfeeding Decision-Making Among Mothers of Preterm Infants.

Background: Mothers of preterm infants face significant challenges to breastfeeding. The theory of planned behavior (TPB) is a well-known framework comprising three domains (attitudes, perceived control, and social norms), which has been used to conceptualize the array of factors that influence health-related behaviors and develop interventions to promote behaviors. Aim: We used the TPB framework to determine the array of factors that contribute to breastfeeding among mothers of preterm infants. Materials and Methods: Using qualitative research methods, we conducted in-depth, semistructured interviews with mothers regarding their experiences feeding their preterm infants according to TPB domains. We developed themes based on an iterative process of review of transcripts and conducted interviews until thematic saturation was reached. Results: We interviewed 23 mothers in 3 states 2 to 6 months after hospital discharge; 22 mothers initiated milk production and 6 were breastfeeding at the time of the interview. Factors that were positive and negative toward breastfeeding were present for all three TPB domains. Regarding attitudes, mothers felt that breastfeeding was a way to bond, that breast milk was healthy and protective, and that breast milk alone was insufficient for a growing preterm infant. Regarding perceived control, mothers felt empowered to breastfeed due to encouragement from hospital staff, friends, and family, and had difficulty overcoming their infant's immature oral feeding skills, competing responsibilities, and perceived infant preference for bottle feeding. Regarding social norms, mothers reported support for and against breastfeeding among hospital and Special Supplemental Nutrition Program for Woman, Infants, and Children (WIC) providers, family, friends, and the media. Conclusion: Interventional studies geared toward breastfeeding promotion among mothers of preterm infants may focus on addressing barriers to direct breastfeeding during the neonatal intensive care unit and early post-discharge time periods.

Facilitators and Barriers to Implementation of Safe Infant Sleep Recommendations in the Hospital Setting.

OBJECTIVE: To identify facilitators and barriers to the implementation of safe sleep recommendations from the American Academy of Pediatrics from the perspective of hospital staff as part of a needs assessment that was used to design a successful quality improvement intervention to change clinical practice. DESIGN: Qualitative design. SETTING: Multiple sites of three hospitals in the northeastern and southern United States. PARTICIPANTS: We used purposeful sampling to identify 46 participants who cared for infants on inpatient hospital units (nurses and other staff members). METHODS: A qualitative researcher used grounded theory to moderate the focus groups. We constructed the initial interview guide and then changed it as needed to capture more information about new ideas as they arose. Researchers from diverse backgrounds participated in the analysis and used the constant comparative method to select important concepts and to develop codes and subsequent themes. We continued to collect data until saturation was reached. RESULTS: We identified themes and subthemes, and the taxonomy fit into the Grol and Wensing framework for change in clinical practice. The six primary themes included The Innovation Itself, The Individual Health Care Professional, The Patient, The Social Context, The Organizational Context, and The Economic and Political Context. CONCLUSION: Participants described facilitators and barriers to the implementation of the American Academy of Pediatrics recommendations for safe infant sleep. Identification of these themes informed our quality improvement intervention to promote safe infant sleep. Findings can be used by others when faced with the need for similar change.

TodaysBaby Quality Improvement: Safe Sleep Teaching and Role Modeling in 8 US Maternity Units.

BACKGROUND AND OBJECTIVES: Nursing education and role modeling can increase adherence to safe sleep practices. Eight US hospital maternity units with variable baseline approaches to education participated in a national multicenter nursing quality improvement (QI) intervention to promote safe sleep practices. The goals at participating maternity units were to (1) increase the rate of mothers who reported receiving safe sleep information from nurses to ≥90% and (2) increase the rates of infants observed sleeping supine in a safe environment to ≥90%. METHODS: A safe sleep QI toolkit, designed for and provided to all sites, included an educational curriculum and tools to use for staff and parent education. Local teams implemented safe sleep education using the tools as plan-do-study-act cycles. After each cycle, audits assessing maternal report of nursing education on safe sleep and inpatient infant sleep position and environment were performed. RESULTS: The QI interventions lasted a median of 160 days (range, 101-273). Mothers reported receiving information on 4 primary safe sleep topics 72% to 95% of the time (a 24%-57% increase over the baseline). Additionally, 93% of infants were observed in a supine sleep position, and 88% of infants were observed in a safe sleep environment (a 24% and 33% increase over baseline, respectively). These rates were sustained up to 12 months later. CONCLUSIONS: Implementation of a multisite QI intervention for safe sleep parenting education and role modeling led to increased knowledge of and compliance with safe sleep practices during postpartum hospitalization.

Factors Associated With Choice of Infant Sleep Position.

BACKGROUND AND OBJECTIVES: The American Academy of Pediatrics recommends infants be placed supine for sleep. Our objectives in this study were to, in a nationally representative sample, examine (1) prevalence of maternal intention regarding infant sleeping position and of actual practice and (2) factors associated with their choices. METHODS: We recruited mothers from 32 US hospitals, oversampling African American and Hispanic mothers, in a nationally representative sample of mothers of infants aged 2 to 6 months. Survey questions assessed choice of usual infant sleeping position, all sleeping positions, intention for sleep position, as well as actual practice. Multivariable logistic regression analyses controlled for demographic, receipt of doctor advice, and theory of planned behavior variables (attitudes, subjective norms, and perceived control). RESULTS: Of the 3297 mothers, 77.3% reported they usually placed their infants in the supine position for sleep, but fewer than half reported that they exclusively did so. Only 43.7% of mothers reported that they both intended to and then actually placed their infants exclusively supine. African American mothers and those who did not complete high school were more likely to intend to use the prone position. Theory of planned behavior factors (attitudes, subjective norms, and perceived control) and doctor advice were associated with maternal choice. CONCLUSIONS: Not all mothers place their infants exclusively supine for sleep. Many mothers intend to place their infants supine yet often do not do so in actual practice. Factors potentially amenable to intervention including attitudes, subjective norms, and doctor advice are associated with intention and practice.

The Effect of Nursing Quality Improvement and Mobile Health Interventions on Infant Sleep Practices: A Randomized Clinical Trial.

Importance: Inadequate adherence to recommendations known to reduce the risk of sudden unexpected infant death has contributed to a slowing in the decline of these deaths. Objective: To assess the effectiveness of 2 interventions separately and combined to promote infant safe sleep practices compared with control interventions. Design, Setting, and Participants: Four-group cluster randomized clinical trial of mothers of healthy term newborns who were recruited between March 2015 and May 2016 at 16 US hospitals with more than 100 births annually. Data collection ended in October 2016. Interventions: All participants were beneficiaries of a nursing quality improvement campaign in infant safe sleep practices (intervention) or breastfeeding (control), and then received a 60-day mobile health program, in which mothers received frequent emails or text messages containing short videos with educational content about infant safe sleep practices (intervention) or breastfeeding (control) and queries about infant care practices. Main Outcomes and Measures: The primary outcome was maternal self-reported adherence to 4 infant safe sleep practices of sleep position (supine), sleep location (room sharing without bed sharing), soft bedding use (none), and pacifier use (any); data were collected by maternal survey when the infant was aged 60 to 240 days. Results: Of the 1600 mothers who were randomized to 1 of 4 groups (400 per group), 1263 completed the survey (78.9%). The mean (SD) maternal age was 28.1 years (5.8 years) and 32.8% of respondents were non-Hispanic white, 32.3% Hispanic, 27.2% non-Hispanic black, and 7.7% other race/ethnicity. The mean (SD) infant age was 11.2 weeks (4.4 weeks) and 51.2% were female. In the adjusted analyses, mothers receiving the safe sleep mobile health intervention had higher prevalence of placing their infants supine compared with mothers receiving the control mobile health intervention (89.1% vs 80.2%, respectively; adjusted risk difference, 8.9% [95% CI, 5.3%-11.7%]), room sharing without bed sharing (82.8% vs 70.4%; adjusted risk difference, 12.4% [95% CI, 9.3%-15.1%]), no soft bedding use (79.4% vs 67.6%; adjusted risk difference, 11.8% [95% CI, 8.1%-15.2%]), and any pacifier use (68.5% vs 59.8%; adjusted risk difference, 8.7% [95% CI, 3.9%-13.1%]). The independent effect of the nursing quality improvement intervention was not significant for all outcomes. Interactions between the 2 interventions were only significant for the supine sleep position. Conclusions and Relevance: Among mothers of healthy term newborns, a mobile health intervention, but not a nursing quality improvement intervention, improved adherence to infant safe sleep practices compared with control interventions. Whether widespread implementation is feasible or if it reduces sudden and unexpected infant death rates remains to be studied. Trial Registration: clinicaltrials.gov Identifier: NCT01713868.