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Mobile health (mHealth) safe sleep messaging increases rates of safe sleep. Bedsharing is more common among breastfeeders. Advice to not bedshare may negatively impact breastfeeding. We compared the impact of safe sleep or breastfeeding mHealth messaging on bedsharing and breastfeeding at 2 to 5 months.This is a secondary analysis of mothers who initiated breastfeeding from a cluster randomized clinical trial of mHealth messaging for safe sleep or breastfeeding. A multi-ethnic sample of 1600 mothers was recruited from 16 US birth hospitals and surveyed at 2 to 5 months regarding the previous 2 weeks' breastfeeding and bedsharing practices. Data on 997 mothers who initiated breastfeeding were analyzed with multivariable generalized estimating logistic regression models to examine the association of mHealth messaging with infant care practices.Overall, exposure to breastfeeding versus safe sleep messaging was not associated with a difference in any breastfeeding at 2 to 5 months (69.3% vs 65.5%, respectively; adjusted odds ratio [aOR] = 1.33 [95% confidence interval, 0.91, 1.94]). Women with shorter planned duration of breastfeeding who received breastfeeding messaging had increased odds of breastfeeding at 2 to 5 months (50% vs 31%; aOR 3.13 [95% CI, 1.47, 6.65]). Mothers who received safe sleep messaging had lower rates of bedsharing overall when compared to breastfeeding messaging (24.8% vs 35.2%; aOR = 0.58 [95% CI, 0.44, 0.78]).In this large multi-ethnic US sample, receipt of safe sleep mHealth messaging was associated with lower rates of bedsharing without negatively impacting breastfeeding rates. Future research should focus on continued development of interventions to improve adherence to both safe sleep and breastfeeding recommendations.

Examine the 1) prevalence of worries among US mothers of infants; 2) association between worries and American Academy of Pediatrics recommended infant care practices (breastfeeding, supine sleep, roomsharing without bedsharing); 3) association of maternal and household characteristics with worries.We analyzed a nationally representative sample of 3165 mothers who were surveyed regarding safe sleep and breastfeeding when infants were 2 to 6 months of age in 2011-2014. We examined the prevalence of 8 maternal worries (housing, job, income, neighborhood, family relationships, health, baby's health, family member health). We used multivariable logistic regression to examine associations of A) both overall number of worries and individual worries with each infant care practice; and B) maternal and household characteristics with worries.Twenty-six percent of mothers reported 0 worries, 26% reported 1-2 worries, 23% reported 3-4 worries, and 25% reported 5-8 worries. Compared to those with 0 worries, mothers with 5-8 worries had increased odds of bedsharing (adjusted odds ratio = 1.60 [1.19-2.14]) and non-supine sleep (aOR = 1.37 [1.07-1.74]). Specific worries associated with increased odds of bedsharing included: housing (aOR = 1.39 [1.09-1.78]), income (aOR = 1.35 [1.09-1.67]), neighborhood (aOR = 1.37 [1.05-1.78]), family relationships (aOR = 1.43 [1.10-1.86]), and health of a family member (aOR = 1.24 [1.06-1.46]). Maternal worries were not associated with infant feeding practices.We found a high prevalence of worries regarding basic needs, family relationships, and health among US mothers. Greater total worries and several individual worries were associated with higher odds of bedsharing. The "cognitive load" of maternal worries may impact adherence to safe sleep practices and requires further investigation.

Objective Describe the effects of the COVID-19 pandemic on subject enrollment in a multicenter randomized controlled trial. Study design We assessed the number of eligible infants approached and consented for enrollment over five separate epochs including baseline, peak pandemic, and gradual but incomplete recovery. Result The pandemic had a major effect on ability to approach parents for consent. Parents approached dropped from 95.4% baseline to 13.1% in the peak pandemic epoch and has not recovered to baseline even in the just-completed post-pandemic epoch (84.9%). Despite the decrease in subjects approached, there was no significant change in the overall consent rate for the study Conclusion The pandemic has significantly limited ability to approach parents of eligible infants for consent, with only partial recovery. Opportunities for interactions of investigators and study coordinators with parents continue to present challenges limiting full recovery.

BACKGROUND AND OBJECTIVES: Donor milk use has increased among very preterm infants because of mounting evidence of health benefits; however, the extent that donor milk is used among healthy term infants in level 1 nurseries is unclear. We aimed to determine (1) national prevalence of and (2) hospital factors associated with donor milk use in level 1 nurseries. METHODS: Among 3040 US birthing hospitals, we randomly selected hospitals from each of 4 US regions (119 in northeast, 120 in Midwest, 116 in west, and 103 in south) for a total of 458 hospitals. We surveyed the nursing leaders of these hospitals from October to December 2017 regarding routine use of donor milk in the level 1 nursery (yes or no). To estimate national prevalence, we weighted responses according to the number of birthing hospitals within each region. We examined relationships between routine donor milk use in the level 1 nursery and hospital characteristics using multivariable logistic regression. RESULTS: In total, 214 of 458 (47%) nursing leaders responded. The national prevalence of routine donor milk use in level 1 nurseries was 17.6%. Eighty-five percent of donor milk programs were ≤5 years old. Donor milk use occurred more often in hospitals with ≥1500 annual births (41.7%), compared to ≤500 annual births (6.3%) (adjusted odds ratio 7.8; 95% confidence interval 1.8–34.4), and in the west (30.9%), compared to the northeast (10.5%) (adjusted odds ratio 4.1; 95% confidence interval [1.1–14.9]). CONCLUSIONS: Although there is limited evidence to support donor milk for healthy infants in the nursery, nearly one-fifth of level 1 US nurseries routinely used donor milk in 2017.

Background Although higher education and healthier practices are positively associated, the explanatory mechanisms for this association remain unclear. The purpose of this study was to better understand mechanisms underlying this association by examining maternal adherence to 2 health-promoting infant care practices: supine placement and breastfeeding. Methods We analyzed nationally representative data from the Study of Attitudes and Factors Effecting Infant Care, which surveyed US mothers after infant birth and 2 months thereafter. Using the Theory of Planned Behavior as a framework, we used structural equation models to elucidate mediational pathways from maternal education to supine infant placement or any breastfeeding. Results Data from 3297 mothers demonstrated 77.0% of infants usually were placed supine, and 57.8% received any breastfeeding. The overall direct effect of maternal educational level on supine placement and any breastfeeding was odds ratio (OR) 1.31 (95% confidence interval [CI] 1.11–1.54) and OR 2.82 (95% CI 2.35–3.37), respectively. In pathway analyses, the strongest associations with both supine position and breastfeeding were seen with positive attitudes (supine: aOR 18.96, 95% CI 9.00–39.92; breastfeeding: aOR 3.86, 95% CI 2.19–6.82) and positive social norms (supine: aOR 6.69, 95% CI 4.52–9.89; breastfeeding: aOR 5.17, 95% CI 4.28–6.23). Mothers with more education had higher odds of both positive attitudes and positive norms for the 2 practices. Conclusions The associations linking educational attainment with health practices are intricate, with multiple mediating pathways. Attitudes and social norms are powerful forces that mediate the association between maternal educational attainment and both infant supine positioning and breastfeeding, and may be important mediators for other health behaviors.

(1) Determine national prevalence and predictors of donor milk programs among levels 2–4 advanced neonatal care facilities; (2) describe characteristics of donor milk programs. We randomly selected 120 U.S. hospitals with levels 2–4 advanced neonatal care facilities among each of four U.S. regions and surveyed the medical directors from July 2017 to November 2017 regarding donor milk use. We weighted responses according to the number of birthing hospitals in each region. Response rate was 213/480 (44%). Twenty-eight percent of level 2 and 88% of levels 3 and 4 neonatal care facilities had donor milk programs. Donor milk programs occurred more often in the South vs. Northeast (aOR 3.7 [1.1, 12.5] and less often in safety-net hospitals (≥75% Medicaid patients) vs. nonsafety-net hospitals (aOR 0.3 [0.1, 0.8]). In 2017, the vast majority of levels 3 and 4 neonatal care facilities had donor milk programs but disparities existed according to the safety-net hospital status and region.

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.

Objective To determine predictors of maternal trust in doctors about advice on infant care practices. Methods Using probability sampling methods, we recruited mothers from 32 US maternity hospitals. Mothers completed a survey 2 to 6 months postpartum that included questions about maternal trust in doctors regarding 6 infant care practices and physician characteristics (doctor asked mother's opinion, doctor is qualified, infant sees 1 main doctor who is/is not of the same ethnicity/race). Prevalence estimates and 95% confidence intervals were calculated for maternal trust in physician advice for each infant care practice. Multivariate logistic regression was used to calculate the independent association of maternal and physician characteristics and trust for each infant care practice, controlling for sociodemographic characteristics. Results Of the 3983 mothers enrolled from January 2011 to March 2014, 3297 (83%) completed the follow-up survey. Maternal trust in the doctor varied according to infant care practice with highest trust for vaccination (89%) and lowest trust for pacifier use (56%). In the adjusted analyses, for all infant care practices, mothers were more likely to trust their doctors if they reported that the doctors were qualified (adjusted odds ratio [AOR], >3.0 for all practices) or if the doctor had asked their opinion (AOR, 1.76–2.43). For mothers who reported seeing 1 main doctor, white mothers were more likely to trust physicians for almost all infant care practices if they reported the doctor was the same race (AOR, 1.54–2.19). Conclusions Physician characteristics and ways of communication were significantly associated with maternal trust in doctors about advice on infant care practices.

To determine whether intermittent hypoxia (IH) persisting after 36 weeks postmenstrual age (PMA) can be attenuated using caffeine doses sufficient to maintain caffeine concentrations >20 μg ml−1. Twenty-seven infants born 20 μg ml−1 on study caffeine doses. IH was significantly attenuated through 38 weeks PMA compared with the control group. Caffeine doses of 14 to 20 mg kg−1 day−1 were sufficient to maintain caffeine concentrations >20 μg ml−1 and reduce IH in preterm infants at 36 to 38 weeks PMA.

Objective To describe the prevalence of breastfeeding and sleep location practices among US mothers and the factors associated with these behaviors, including advice received regarding these practices. Methods A nationally representative sample of 3218 mothers who spoke English or Spanish were enrolled at a sample of 32 US birth hospitals between January 2011 and March 2014. Results Exclusive breastfeeding was reported by 30.5% of mothers, while an additional 29.5% reported partial breastfeeding. The majority of mothers, 65.5%, reported usually room sharing without bed sharing, while 20.7% reported bed sharing. Compared to mothers who room shared without bed sharing, mothers who bed shared were more likely to report exclusive breastfeeding (adjusted odds ratio 2.46, 95% confidence interval 1.76, 3.45) or partial breastfeeding (adjusted odds ratio 1.75, 95% confidence interval 1.33, 2.31). The majority of mothers reported usually room sharing without bed sharing regardless of feeding practices, including 58.2% of exclusively breastfeeding mothers and 70.0% of nonbreastfeeding mothers. Receiving advice regarding sleep location or breastfeeding increased adherence to recommendations in a dose response manner (the adjusted odds of room sharing without bed sharing and exclusive breastfeeding increased as the relevant advice score increased); however, receiving advice regarding sleep location did not affect feeding practices. Conclusions Many mothers have not adopted the recommended infant sleep location or feeding practices. Receiving advice from multiple sources appears to promote adherence in a dose response manner. Many women are able to both breastfeed and room share without bed sharing, and advice to adhere to both of these recommendations did not decrease breastfeeding rates.

Aims Caffeine concentrations in preterm infants are usually measured in the blood. However, salivary assays may provide a valid and practical alternative. The present study explored the validity and clinical utility of salivary caffeine concentrations as an alternative to blood concentrations and developed a novel plasma/salivary caffeine distribution model. Methods Paired salivary and plasma samples were obtained in 29 infants. Salivary samples were obtained using a commercially available salivary collection system. Caffeine concentrations in the saliva and plasma were determined using high-performance liquid chromatography. A population pharmacokinetic (PK) model was developed using NONMEM 7.3. Results The mean (± standard deviation) gestational age (GA) at birth and birth weight were 27.9 ± 2.1 weeks and 1171.6 ± 384.9 g, respectively. Paired samples were obtained at a mean postmenstrual age (PMA) of 35.5 ± 1.1 weeks. The range of plasma caffeine concentrations was 9.5–54.1 μg ml−1, with a mean difference (95% confidence interval) between plasma and salivary concentrations of −0.18 μg ml−1 (−1.90, 1.54). Salivary and plasma caffeine concentrations were strongly correlated (Pearson's correlation coefficient = 0.87, P

Objectives (1) Determine the prevalence of maternal trust in advice sources on infant care practices; (2) Investigate the association of maternal and infant characteristics with trust in advice sources on infant care practices. Methods Using probability sampling methods, we recruited mothers from 32 U.S. maternity hospitals with oversampling of Black and Hispanic women resulting in a nationally representative sample of mothers of infants aged 2–6 months. Survey questions assessed maternal trust in advice sources (physicians, nurses, family, friends, and media) regarding infant care practices including infant sleep practices (sleep position, bed sharing, and pacifier use), feeding, and vaccination. Weighted frequencies of maternal trust in advice sources were calculated to obtain prevalence estimates. Multivariable logistic regression was used to assess the association of maternal and infant characteristics with maternal trust in advice sources. Results Mothers had the greatest trust in doctors for advice on all infant care practices (56–89 %), while trust was lowest for friends (13–22 %) and the media (10–14 %). In the adjusted analyses, there were significant associations of maternal race/ethnicity, education, and age with trust in advice sources. Conclusions for Practice Maternal trust in advice about infant care practices varied significantly by source. A better understanding of which advice sources are most trusted by mothers, as well as the factors associated with maternal trust, may guide the development of more effective strategies to improve adherence to health promoting infant care practices.

OBJECTIVES: To determine mediators of improvements in infant safe-sleep (SS) practices in a mobile health intervention. METHODS: In a cluster-randomized controlled trial, mothers received SS intervention or breastfeeding control videos for 60 days. Maternal responses about infant sleep position and location (outcomes) and mediators (attitudes, perceived social norms, and perceived control) from the theory of planned behavior were assessed. Intervention effects on mediators and association between mediators and outcomes were examined. RESULTS: Of 1600 recruited, 1263 mothers participated. Mothers receiving SS videos were more likely to have positive attitudes and norms for supine sleep (attitudes: adjusted odds ratio [aOR] = 2.35 [95% confidence interval (CI) 1.72 to 3.20]; norms: aOR = 1.75 [95% CI 1.27 to 2.42]) and recommended sleep location (attitudes: aOR = 1.91 [95% CI 1.54 to 2.36]; norms: aOR = 1.37 [95% CI 1.13 to 1.66]). Positive attitudes and norms toward supine sleep and room-sharing without bed-sharing were associated with higher odds of both practices (supine: aOR = 8.25 [95% CI 4.72 to 14.43] for positive attitudes and aOR = 6.67 [95% CI 4.25 to 10.46] for norms; room-sharing: aOR = 7.14 [95% CI 5.35 to 9.53] for positive attitudes and aOR = 4.44 [95% CI 3.03 to 6.51] for norms). Both positive attitudes and positive norms mediated the effect of the intervention. CONCLUSIONS: The intervention achieved success in improving adherence to SS recommendations by changing maternal attitudes and norms about supine sleeping and room-sharing without bed-sharing. Recognition that these attitudes and norms appear to be the main drivers of mothers’ choices regarding infant-sleep practices should inform health messaging strategies to promote SS.

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.

BACKGROUND: Advice has been associated with increased adherence to recommended infant care practices, and may represent a modifiable factor to promote infant health. METHODS: A stratified, 2-stage, clustered design, with oversampling of black and Hispanic mothers, was used to survey a nationally representative sample of 1031 mothers of infants aged 2 to 6 months. Survey questions assessed advice received from doctors, birth hospital nurses, family, and media regarding immunization, breastfeeding, sleep position, sleep location, and pacifier use. Weighted frequencies of no advice and advice consistent with recommendations were calculated to obtain prevalence estimates. Multivariable logistic regression analyses were performed to assess factors associated with receipt of recommendation consistent advice. RESULTS: Although doctors were the most prevalent source of reported advice, ∼20% of mothers reported no doctor advice for breastfeeding or sleep position, and more than 50% reported no advice regarding sleep location or pacifier use. Reported advice from nurses was generally similar to doctors. The prevalence of any advice from family or media was 20% to 56% for nearly all care practices, and advice given was often inconsistent with recommendations. The only factors that were consistently associated with receipt of recommendation consistent advice were race/ethnicity and parity; black and Hispanic mothers and first-time mothers were more likely to report recommendation consistent advice. CONCLUSIONS: Mothers commonly report receiving either no advice or recommendation inconsistent advice from each of the 4 sources we studied. By identifying care practices with low prevalence of recommendation consistent advice from potentially important advisors, our findings highlight opportunities for future intervention.

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.

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.

Although the incidence of sudden unexpected infant death declined by nearly 50% in the 1990s, there has been little improvement in the past 15 years. Significant disparities in infant sleep practices and sleep-associated death exist, particularly by maternal race/ethnicity. This article provides a brief overview of recent observational and intervention studies related to infant sleep practices to describe the context and motivation for the population-based Study of Attitudes and Factors Effecting Infant Care (SAFE). [ Pediatr Ann . 2017;46(8):e291–e296.]

BACKGROUND: Acute otitis media (AOM) is a common childhood illness and the leading indication for antibiotic prescriptions for US children. Xylitol, a naturally occurring sugar alcohol, can reduce AOM when given 5 times per day as a gum or syrup, but a more convenient dosing regimen is needed for widespread adoption. METHODS: We designed a pragmatic practice-based randomized controlled trial to determine if viscous xylitol solution at a dose of 5 g 3 times per day could reduce the occurrence of clinically diagnosed AOM among otitis-prone children 6 months through 5 years of age. RESULTS: A total of 326 subjects were enrolled, with 160 allocated to xylitol and 166 to placebo. In the primary analysis of time to first clinically diagnosed AOM episode, the hazard ratio for xylitol versus placebo recipients was 0.88 (95% confidence interval [CI] 0.61 to 1.3). In secondary analyses, the incidence of AOM was 0.53 episodes per 90 days in the xylitol group versus 0.59 in the placebo group (difference 0.06; 95% CI –0.25 to 0.13); total antibiotic use was 6.8 days per 90 days in the xylitol group versus 6.4 in the placebo group (difference 0.4; 95% CI –1.8 to 2.7). The lack of effectiveness was not explained by nonadherence to treatment, as the hazard ratio for those taking nearly all assigned xylitol compared with those taking none was 0.93 (95% CI 0.56 to 1.57). CONCLUSIONS: Viscous xylitol solution in a dose of 5 g 3 times per day was ineffective in reducing clinically diagnosed AOM among otitis-prone children.

A needle-free delivery system may lead to improved satisfaction and compliance, as well as reduced anxiety among patients requiring frequent or ongoing injections. This report describes a first-in-man assessment comparing Portal Instruments’ innovative needle-free injection system with subcutaneous injections using a 27G needle. Forty healthy volunteer participants each received a total of four injections of 1.0 mL sterile saline solution, two with a standard subcutaneous injection using a 27G needle, and two using the Portal injection system. Perception of pain was measured using a 100-mm visual analog scale (VAS). Injection site reactions were assessed at 2 min and at 20–30 min after each injection. Follow-up contact was made 24–48 h after the injections. Subject preference regarding injection type was also assessed. VAS pain scores at Portal injection sites met the criteria to be considered non-inferior to the pain reported at 27G needle injection sites (i.e., upper 95% confidence bound less than +5 mm). Based on a mixed effects model, at time 0, accounting for potential confounding variables, the adjusted difference in VAS scores indicated that Portal injections were 6.5 mm lower than the 27G needle injections (95% CI −10.5, −2.5). No clinically important adverse events were noted. Portal injections were preferred by 24 (60%) of the subjects (P = 0.0015). As an early step in the development of this new needle-free delivery system, the current study has shown that a 1.0-mL saline injection can be given with less pain reported than a standard subcutaneous injection using a 27G needle.

Objective To examine variation in safe sleep and breastfeeding practices among US non-Hispanic black (NHB) mothers according to birth country. Methods We analyzed NHB mothers who were surveyed regarding safe sleep and breastfeeding practices when their infants were 2 to 6 months of age in 2011 to 2014, as part of a larger national study. We examined prevalences of safe sleep and breastfeeding practices according to birth country and examined odds of adherence to American Academy of Pediatrics recommended safe sleep and breastfeeding practices in foreign-born NHB mothers, compared with US-born NHB mothers. Our multivariate models included adjustment for maternal age, education, income, and US geographic region, and infant age at the time of the survey. Results Among 828 NHB mothers, 690 (83%) were US-born, 42 (5%) were African-born, 47 (6%) were Haitian-born, 24 (3%) were Jamaican-born, and 25 (3%) were born elsewhere. In the analysis of 803 US, African-, Haitian-, and Jamaican-born mothers, we found that Jamaican-born mothers had a lower rate of supine sleep compared with US-born mothers (40% vs 66%; adjusted odds ratio, 0.34; 95% confidence interval, 0.18–0.63). African-born mothers had lower rates of bedsharing compared with US-born mothers (11% vs 25% adjusted odds ratio, 0.22; 95% confidence interval, 0.11–0.46). Foreign-born mothers had higher rates of any and exclusive breastfeeding, compared with US-born mothers (85% and 40% vs 23% and 13%, respectively). Conclusions Safe sleep and breastfeeding practices vary among US NHB mothers according to birth country. These data illustrate the importance of recognizing heterogeneity of safe sleep and breastfeeding practices within racial/ethnic groups.

Objective To assess how mothers' choice of e-mail or text messages (SMS) to receive safe sleep communications is associated with educational video viewing and responses to care practice queries. Methods Seven hundred ninety-two new mothers received safe sleep-related communications for 60 days after newborn hospital discharge as part of a trial of health education interventions on infant care practices. Mothers chose e-mail or SMS for study communications and were sent 22 short safe sleep videos and 41 queries regarding infant care practices. Results Study communications via e-mail were elected by 55.7% of participants. The SMS group had a modestly higher overall view rate of videos (59.1% vs 54.4%; adjusted odds ratio [aOR], 1.39; 95% confidence interval [CI], 1.07–1.81) and a substantially higher response rate to queries (70.0% vs 45.2%; aOR, 3.48; 95% CI, 2.74–4.43). Conclusions Participants more commonly opted to receive infant care practice videos and queries via e-mail. SMS was associated with higher viewing and response rates, especially for query responses. These results highlight the importance of understanding how specific modalities of communication might vary in reach.

Objective To assess the association between maternal birth country and adherence to the American Academy of Pediatrics safe sleep recommendations in a national sample of Hispanic mothers, given that data assessing the heterogeneity of infant care practices among Hispanics are lacking. Study design We used a stratified, 2-stage, clustered design to obtain a nationally representative sample of mothers from 32 US intrapartum hospitals. A total of 907 completed follow-up surveys (administered 2-6 months postpartum) were received from mothers who self-identified as Hispanic/Latina, forming our sample, which we divided into 4 subpopulations by birth country (US, Mexico, Central/South America, and Caribbean). Prevalence estimates and aORs were determined for infant sleep position, location, breastfeeding, and maternal smoking. Results When compared with US-born mothers, we found that mothers born in the Caribbean (aOR 4.56) and Central/South America (aOR 2.68) were significantly more likely to room share without bed sharing. Caribbean-born mothers were significantly less likely to place infants to sleep supine (aOR 0.41). Mothers born in Mexico (aOR 1.67) and Central/South America (aOR 2.57) were significantly more likely to exclusively breastfeed; Caribbean-born mothers (aOR 0.13) were significantly less likely to do so. Foreign-born mothers were significantly less likely to smoke before and during pregnancy. Conclusions Among US Hispanics, adherence to American Academy of Pediatrics safe sleep recommendations varies widely by maternal birth country. These data illustrate the importance of examining behavioral heterogeneity among ethnic groups and have potential relevance for developing targeted interventions for safe infant sleep.

The American Academy of Pediatrics (AAP) strongly recommends the supine-only sleep position for infants and issued 2 more sudden infant death syndrome (SIDS) reduction recommendations: avoid bed sharing and use pacifiers during sleep. In this study, we investigated the following: 1) if mothers from at risk populations rate physicians as qualified to give advice about sleep practices and 2) if these ratings were associated with reports of recommended practice.A cross-sectional survey of mothers (N=2355) of infants aged8 months was conducted at Women, Infants, and Children (WIC) Program centers in 6 cities from 2006 to 2008. The predictor measures were maternal rating of physician qualification to give advice about 3 recommended sleep practices and reported nature of physician advice. The dependent measures were maternal report of usage of recommended behavior: 1) "infant usually placed supine for sleep," 2) "infant usually does not share a bed with an adult during sleep," and 3) "infant usually uses a pacifier during sleep."Physician qualification ratings varied by topic: sleep position (80%), bed sharing (69%), and pacifier use (60%). High ratings of physician qualification were associated with maternal reports of recommended behavior: supine sleep (adjusted odds ratio [AOR] 2.1, 95% confidence interval [CI], 1.6-2.6); usually no bed sharing (AOR 1.5, 95% CI, 1.2-1.9), and usually use a pacifier during sleep (AOR 1.2, 95% CI, 1.0-1.5).High maternal ratings of physician qualification to give advice on 2 of the 3 recommended sleep practices targeted to reduce the risk of SIDS were significantly associated with maternal report of using these behaviors. Lower ratings of physician qualification to give advice about these sleep practices may undermine physician effectiveness in promoting the recommended behavior.

Midazolam in an autoinjector was evaluated in an openlabel dose escalation study involving 39 healthy participants. Safety and pharmacokinetic parameters were determined for doses ranging from 5 to 30 mg. No serious adverse events were noted during the study. Two participants (30 mg) experienced changes in their electrocardiogram (trigeminy and prolongation of QRS complex) that met the criteria for dose-limiting adverse events. No significant respiratory depression was noted during the study. The midazolam doses studied exhibited a median t max of 0.5 hours with a geometric mean terminal elimination half-life value of 4.1 hours (range, 2.9- 4 . 5 hours). The extent of systemic exposure, assessed by area under the curve (AUC) and maximum concentration (C max ), tended to increase proportionally with increasing doses from 5 to 30 mg; however, for the male 30-mg group, there was evidence of a larger than proportional increase in AUC.

Objective To identify factors associated with infant sleep location. Study design Demographic information and infant care practices were assessed for 708 mothers of infants ages 0 to 8 months at Women, Infants and Children centers. Generalized linear latent mixed models were constructed for the outcome, sleeping arrangement last night (room-sharing without bed-sharing versus bed-sharing, and room-sharing without bed-sharing versus sleeping in separate rooms). Results Two-thirds of the mothers were African-American. A total of 48.6% mothers room-shared without bed-sharing, 32.5% bed-shared, and 18.9% slept in separate rooms. Compared with infants who slept in separate rooms, infants who room-shared without bed-sharing were more likely to be Hispanic (odds ratio [OR], 2.58, 95% CI 1.11-5.98) and younger (3.66- and 1.74-times more likely for infants 0-1 month old and 2-3 months old, respectively, as compared with older infants). Compared with infants who bed-shared, infants who room-shared without bed-sharing were more likely to be 0 to 1 month old (OR, 1.57; 95% CI, 1.05-2.35) and less likely to be African-American (OR, 0.43; 95% CI, 0.26-0.70) or have a teenage mother (OR, 0.37; 95% CI, 0.23-0.58). Conclusions Approximately one-third of mothers and infants bed-share, despite increased risk of sudden infant death syndrome (SIDS). The factors associated with bed-sharing are also associated with SIDS, likely rendering infants with these characteristics at high risk for SIDS.

In 1,079 infants monitored for >700,000 hr at home for apnea or bradycardia, we found an association between infants having multiple events exceeding conventional or a priori defined more extreme thresholds and less favorable developmental outcome at 1 year of age than infants with few or no events. If it is necessary to prevent such events to minimize risk for developmental morbidity, there is reason to determine whether there are disturbances in advance of the apnea or bradycardia that herald their onset. In the 85 infants with at least 1 extreme event and 1 conventional event, we hypothesized that apnea and bradycardia do not occur de novo but rather are preceded by cardiorespiratory and hemoglobin O2 saturation changes. We compared recorded time intervals preceding these events, and we analyzed three preceding time intervals for each conventional and extreme event, and each non-event recording: Time-2 hr: up to 2 hr before; Time-1 hr: up to 1 hr before; and Time-75 sec: the 75 sec immediately preceding each event. O2 saturation progressively decreased preceding both conventional and extreme events, and progressive increases occurred in heart and breathing rate variability. Duration of respiratory pauses and of periodic breathing progressively increased preceding conventional events, respiratory rate variability increased immediately preceding conventional events and at 1 hr preceding extreme events, and O2 saturation decreased immediately preceding both conventional and extreme events. Thus, conventional and extreme events do not occur de novo but rather are preceded by autonomic instability of the cardiorespiratory system. Pediatr Pulmonol. 2008; 43:87–98. © 2007 Wiley-Liss, Inc.

OBJECTIVE: To determine the extent to which post-discharge feeding behaviors and interactions among caregiver-preterm infant dyads are associated with infant neurodevelopment at one year corrected gestational age (CGA). STUDY DESIGN: We studied 119 preterm infants born

Context: Anemia is common in the critically ill and results in a large number of red blood cell transfusions. Recent data have shown that red blood cell transfusions in critically ill patients can be decreased with recombinant human erythropoietin (rHuEPO) therapy during their intensive care unit stay. Objective: To assess the efficacy of rHuEPO therapy in decreasing the occurrence of red blood cell transfusions in patients admitted to a long-term acute care facility (LTAC). Design: A prospective, randomized, double-blind, placebocontrolled, multiple-center trial. Setting: Two long-term acute care facilities. Patients: A total of 86 patients who met eligibility criteria were enrolled in the study with 42 randomized to rHuEPO and 44 to placebo. Interventions: Study drug (rHuEPO 40,000 units) or a placebo was administered by subcutaneous injection before day 7 of long-term acute care facility admission and continued weekly for up to 12 doses. Main Outcome Measures: The primary efficacy end point was cumulative red blood cell units transfused. Secondary efficacy end points were the percent of patients receiving any red blood cell transfusion; the percent of patients alive and transfusion independent; cumulative mortality; and change in hematologic variables from baseline. Logistic regression was used to adjust the odds ratio for red blood cell transfusion. All end points were assessed at both study day 42 and study day 84. Results: The baseline hemoglobin level was higher in the rHuEPO group (9.9 1.15 g/dL vs. 9.3 1.41 g/dL, p .02) as was the pretransfusion hemoglobin level (8.0 0.5 g/dL vs. 7.5 0.8 g/dL, p .04). At day 84, patients receiving rHuEPO received fewer red blood cell transfusions (median units per patient 0 vs. 2, p .05), and the ratio of red blood cell transfusion rates per day alive was 0.61 with 95% confidence interval of 0.2, 1.01, indicating a 39% relative reduction in transfusion burden for the rHuEPO group compared with placebo. There was also a trend at day 84 toward a reduction in the total units of red blood cells transfused in the rHuEPO group (113 units of placebo vs. 73 units of rHuEPO). Patients receiving rHuEPO were also less likely to be transfused (64% placebo vs. 41% rHuEPO, p .05; adjusted odds ratio 0.47, 95% confidence interval 0.19, 1.16). Most of the transfusion benefit of rHuEPO occurred by study day 42. Increase in hemoglobin from baseline to final was greater in the rHuEPO group (1.0 2 g/dL vs. 0.4 1.7 g/dL, p < .001). Mortality rate (19% rHuEPO, 29.5% placebo, p .17; relative risk, 0.55, 95% confidence interval 0.21‐1.43) and serious adverse clinical events (38 % rHuEPO, 32% placebo, p .65) were not significantly different between the two groups. Conclusions: In patients admitted to a long-term acute care facility, administration of weekly rHuEPO results in a significant reduction in exposure to allogeneic red blood cell transfusion during the initial 42 days of rHuEPO therapy, with little additional benefit achieved with therapy to 84 days. Despite receiving fewer red blood cell transfusions, patients treated with rHuEPO achieve a higher hemoglobin level. (Crit Care Med 2006; 34:2310‐2316)

OBJECTIVES. The risk for sudden infant death syndrome in black infants is twice that of white infants, and their parents are less likely to place them in the supine position for sleep. We previously identified barriers for parents to follow recommendations for sleep position. Our objective with this study was to quantify these barriers, particularly among low-income, primarily black mothers. DESIGN/METHODS. We conducted face-to-face interviews with 671 mothers, 64% of whom were black, who attended Women, Infants, and Children Program centers in Boston, Massachusetts, Dallas, Texas, Los Angeles, California, and New Haven, Connecticut. We used univariate analyses to quantify factors that were associated with choice of sleeping position and multivariate logistic regression to calculate adjusted odds ratios for the 2 outcome variables: “ever” (meaning usually, sometimes, or last night) put infant in the prone position for sleep and “usually” put infant in the supine position to sleep. RESULTS. Fifty-nine percent of mothers reported supine, 25% side, 15% prone, and 1% other as the usual position. Thirty-four percent reported that they ever placed infants in the prone position. Seventy-two percent said that a nurse, 53% a doctor, and 38% a female friend or relative provided source of advice. Only 42% reported that a nurse, only 36% a doctor, and only 15% a female friend or relative recommended the supine position for sleep. When a female friend or relative recommended the prone position, mothers were more likely ever to place their infants in the prone position and less likely usually to choose supine compared with those who received no advice from friends or relatives. When a doctor or a nurse recommended a nonsupine position, the mothers were less likely to choose supine compared with those who received no advice from a doctor or a nurse. Mothers who trusted the opinion of a doctor or a nurse about infant sleeping position were more likely to place their infants in the supine position. Half of the mothers believed that infants were more likely to choke when supine, and they were less likely to place their infants supine. Mothers who believed that infants are more comfortable in the prone position (36%) were more likely to place their infants prone. Twenty-nine percent believed that having their infants sleep with an adult helps prevent sudden infant death syndrome, and only 43% believed that sudden infant death syndrome is related to sleeping position. CONCLUSIONS. We identified specific barriers to placing infants in the supine position for sleep (lack of or wrong advice, lack of trust in providers, knowledge and concerns about safety and comfort) in low-income, primarily black mothers that should be considered when designing interventions to get more infants onto their back for sleep.

OBJECTIVE. The objective of this study was to compare the respiratory physiologic features of healthy term infants placed in either a car bed or a car safety seat.METHODS. Within the first 1 week of life, 67 healthy term infants were recruited and assigned randomly to be monitored in either a car bed (33 infants) or a car safety seat (34 infants). Physiologic data, including oxygen saturation and frequency and type of apnea, were obtained and analyzed in a blinded manner.RESULTS. The groups spent similar amounts of time in the devices (car bed: 71.6 minutes; car seat: 74.2 minutes). The mean oxygen saturation values were not different between the groups (car bed: 97.1%; car seat: 97.3%). The percentages of time with oxygen saturation of CONCLUSIONS. The respiratory physiologic features of infants in the 2 car safety devices were observed to be similar. Of note, substantial periods of time with oxygen saturation of

Background.—African American infants have a higher incidence of SIDS and increased risk of being placed in the prone position for sleep. Objective.—To determine new barriers and more information about previously identified barriers that interfere with adherence to the Back-to-Sleep recommendations among inner-city, primarily African Americans. Design/Methods.—We conducted 9 focus groups with caregivers of infants and young children from women, infants, and children centers and clinics in New Haven and Boston. Themes were identified using standard qualitative techniques. Results.—Forty-nine caregivers participated, of whom 86% were African American, 6% were Hispanic, 4% were white, and 4% were other. Four themes were identified: 1) Safety: Participants chose the position for their infants based on which position they believed to be the safest. Some participants did not choose to put their infants in the supine position for sleep because they feared their infants would choke; 2) Advice: Participants relied on the advice of more experienced female family members. Health care providers were not uniformly a trusted source of advice; 3) Comfort: Participants made choices about their infants sleeping positions based on their perceptions of whether the infants appeared comfortable. Participants thought that their infants appeared more comfortable in the prone position; 4) Knowledge: Some participants had either limited or erroneous knowledge about the Back-to-Sleep recommendations. Conclusions.—We identified multiple barriers to adherence to recommendations regarding infant sleep position. Data obtained from these focus groups could be used to design educational interventions aimed at improving communication about and adherence to the Back-to-Sleep recommendations.

To determine if infants with cardiorespiratory events detected by home memory monitoring during early infancy have decreased neurodevelopmental performance.Infants (n = 256) enrolled in the Collaborative Home Infant Monitoring Evaluation also completed the Bayley Scales of Infant Development II at 92 weeks' postconceptional age. Infants were classified as having 0, 1 to 4, or 5+ cardiorespiratory events. Events were defined as apneaor=20 seconds or heart rate60 to 80 bpm or50 to 60 bpm, foror=5 to 15 seconds, depending on age.For term infants, having 0, 1 to 4, and 5+ cardiorespiratory events was associated with unadjusted mean Mental Developmental Index (MDI) values (+/-SD) of 103.6 (10.6), 104.2 (10.7), and 97.7 (10.9), respectively, and mean Psychomotor Developmental Index (PDI) values of 109.5 (16.6), 105.8 (16.5), and 100.2 (17.4). For preterm infants, having 0, 1 to 4, and 5+ cardiorespiratory events was associated with unadjusted mean MDI values of 100.4 (10.3), 96.8 (11.5), and 95.8 (10.6), respectively, and mean PDI values of 91.7 (19.2), 93.8 (15.5), and 94.4 (17.7). The adjusted difference in mean MDI scores with 5+ events compared with 0 events was 5.6 points lower in term infants ( P = .03) and 4.9 points lower in preterm infants ( P = .04).Having 5+ conventional events is associated with lower adjusted mean differences in MDI in term and preterm infants.

Objective. A review of the evidence concerning the effect of chronic or intermittent hypoxia on cognition in childhood was performed by using both a systematic review of the literature and critical appraisal criteria of causality. Because of the significant impact of behavioral disorders such as attention-deficit/hyperactivity disorder on certain cognitive functions as well as academic achievement, the review also included articles that addressed behavioral outcomes.Methods. Both direct and indirect evidence were collected. A structured Medline search was conducted from the years 1966-2000 by using the OVID interface. Both English- and non–English-language citations were included. Significant articles identified by the reviewers up to 2003 were also included. To be included as direct evidence, an article needed to be an original report in a peer-reviewed journal with data on cognitive, behavioral, or academic outcomes in children up to 14 years old, with clinical conditions likely to be associated with exposure to chronic or intermittent hypoxia. Indirect evidence from other reviews and publications in closely related fields, including experimental studies in adults, was used to help formulate conclusions. Two reviewers screened abstracts and titles. Each article included as direct evidence received a structured evaluation by 2 reviewers. Adjudication of differences was performed by a group of 2 reviewers and a research consultant. After this review, tables of evidence were constructed that were used as the basis for group discussion and consensus development. Indirect evidence assigned by topic to specific reviewers was also presented as part of this process. A formal procedure was used to rank the studies by design strength. The critical appraisal criteria for causation described in Evidence Based Pediatrics and Child Health (Moyer V, Elliott E, Davis R, et al, eds. London, United Kingdom: BMJ Books; 2000:46–55) were used to develop consensus on causality.Results. A total of 788 literature citations were screened. For the final analysis, 55 articles met the criteria for inclusion in the direct evidence. Of these, 43 (78.2%) reported an adverse effect. Of the 37 controlled studies, 31 (83.8%) reported an adverse effect. Adverse effects were noted at every level of arterial oxygen saturation and for exposure at every age level except for premature newborns. The studies were classified into 5 clinical categories: congenital heart disease (CHD), sleep-disordered breathing (SDB), asthma, chronic ventilatory impairment, and respiratory instability in infants. Two of these categories, CHD and SDB, which accounted for 42 (76.4%) of the included articles, fulfilled the Evidence Based Pediatrics and Child Health criteria for causation. The indirect evidence included 8 reviews, 1 meta-analysis, and 10 original reports covering the fields of adult anoxia, animal research, SDB in adults, natural and experimental high-altitude studies, perinatal hypoxic-ischemic encephalopathy, anemia, and carbon-monoxide poisoning. The studies of high-altitude and carbon-monoxide poisoning provided evidence for causality.Conclusions. Adverse impacts of chronic or intermittent hypoxia on development, behavior, and academic achievement have been reported in many well-designed and controlled studies in children with CHD and SDB as well as in a variety of experimental studies in adults. This should be taken into account in any situation that may expose children to hypoxia. Because adverse effects have been noted at even mild levels of oxygen desaturation, future research should include precisely defined data on exposure to all levels of desaturation.

Ontogeny of arousal data constitute a vital supplement to the sparse literature on spontaneous neuronal activity. These data demonstrate that measurable infant spontaneous arousals (SAs) with an inherent oscillatory entrainment occur six times more in active sleep than in quiet sleep of the same duration and are identifiable as a human neurobiologic function. These SAs are not significantly associated with race or ethnicity, gender, total hours spent sleeping, percent time spent in active or quiet sleep, preterm status, history of a life-threatening event, having had a sibling who died of sudden infant death syndrome (SIDS), or having had a mother who smoked during this pregnancy. As measurable neurophysiologic events, SAs establish parameters for research at molecular and molar levels focusing on several critical areas: (1) the neuronal control of SA related to neurotransmitters, (2) as a significant antecedent factor in clinical cardiorespiratory events occurring in infants at high epidemiologic risk for SIDS; (3) as a regulatory biologic factor underlying temperament and executive cognitive functioning, and (4) morbidity and mortality effects possibly related to therapeutic interventions that alter SA levels.

Bed sharing has been promoted as facilitating breastfeeding but also may increase risks for sudden, unexpected infant deaths. This prospective cohort study was performed to determine the prevalence of adult and infant bed sharing and its association with maternal and infant characteristics. Demographic data were collected from 10,355 infant-mother pairs at birth hospitals in Eastern Massachusetts and Northwest Ohio, and follow-up data were collected at 1, 3, and 6 months by questionnaire. Associations with bed sharing were estimated using odds ratios and 95% confidence intervals from multiple logistic regression models while adjusting for confounding variables. At 1, 3, and 6 months, 22%, 14%, and 13% of infant-mother pairs shared a bed, respectively. On multivariate analysis, race/ethnicity and breastfeeding seemed to have the strongest association with bed sharing. These factors need to be considered in any comprehensive risk to benefit analysis of bed sharing.

Because racial discrimination might contribute to their excess of preterm births, we assessed experiences of racism in relation to preterm birth among African-American women.We used data from the Black Women's Health Study, a follow-up study of African-American women begun in 1995. Data on subsequent singleton births were obtained using follow-up questionnaires in 1997 and 1999; nine questions about experiences of racism were asked in 1997. We compared mothers of 422 babies born 3 or more weeks early (because of premature labor for unknown reasons or rupture of membranes) with mothers of 4544 babies of longer gestation. We used generalized estimating equation models to estimate odds ratios (ORs) for preterm birth, controlling potential confounders.The adjusted ORs for preterm birth were 1.3 (95% confidence interval [CI] = 1.1-1.6) for women who reported unfair treatment on the job and 1.4 (1.0-1.9) for women who reported that people acted afraid of them at least once a week. Overall ORs for the seven other racism questions were close to 1.0. Among 491 women with/=12 years of education, ORs were 2.0 or greater for four racism variables.These data provide some evidence for an increase in preterm birth among women who report experiences of racism, particularly women with lower levels of education.

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

BACKGROUND:Use of potentially hazardous bedding, as defined by the American Academy of Pediatrics (eg, pillows, quilts, comforters, loose bedding), is a modifiable risk factor for sudden infant death syndrome and unintentional sleep-related suffocation. The proportion of US infants sleeping with these types of bedding is unknown.METHODS:To investigate the US prevalence of and trends in bedding use, we analyzed 1993–2010 data from the National Infant Sleep Position study. Infants reported as being usually placed to sleep with blankets, quilts, pillows, and other similar materials under or covering them in the last 2 weeks were classified as bedding users. Logistic regression was used to describe characteristics associated with bedding use.RESULTS:From 1993 to 2010, bedding use declined but remained a widespread practice (moving average of 85.9% in 1993–1995 to 54.7% in 2008–2010). Prevalence was highest for infants of teen-aged mothers (83.5%) and lowest for infants born at term (55.6%). Bedding use was also frequently reported among infants sleeping in adult beds, on their sides, and on a shared surface. The rate of decline in bedding use was markedly less from 2001–2010 compared with 1993–2000. For 2007 to 2010, the strongest predictors (adjusted odds ratio: ≥1.5) of bedding use were young maternal age, non-white race and ethnicity, and not being college educated.CONCLUSIONS:Bedding use for infant sleep remains common despite recommendations against this practice. Understanding trends in bedding use is important for tailoring safe sleep interventions.

To determine whether the administration of recombinant human erythropoietin (rHuEPO) to critically ill patients in the intensive care unit (ICU) would reduce the number of red blood cell (RBC) transfusions required.A prospective, randomized, double-blind, placebo-controlled, multicenter trial.ICUs at three academic tertiary care medical centers.A total of 160 patients who were admitted to the ICU and met the eligibility criteria were enrolled in the study (80 into the rHuEPO group; 80 into the placebo group).Patients were randomized to receive either rHuEPO or placebo. The study drug (300 units/kg of rHuEPO or placebo) was administered by subcutaneous injection beginning ICU day 3 and continuing daily for a total of 5 days (until ICU day 7). The subsequent dosing schedule was every other day to achieve a hematocrit (Hct) concentration of38%. The study drug was given for a minimum of 2 wks or until ICU discharge (for subjects with ICU lengths of stay2 wks) up to a total of 6 wks (42 days) postrandomization.The cumulative number of units of RBCs transfused was significantly less in the rHuEPO group than in the placebo group (p.002, Kolmogorov-Smirnov test). The rHuEPO group was transfused with a total of 166 units of RBCs vs. 305 units of RBCs transfused in the placebo group. The final Hct concentration of the rHuEPO patients was significantly greater than the final Hct concentration of placebo patients (35.1+/-5.6 vs. 31.6+/-4.1; p.01, respectively). A total of 45% of patients in the rHuEPO group received a blood transfusion between days 8 and 42 or died before study day 42 compared with 55% of patients in the placebo group (relative risk, 0.8; 95% confidence interval, 0.6, 1.1). There were no significant differences between the two groups either in mortality or in the frequency of adverse events.The administration of rHuEPO to critically ill patients is effective in raising their Hct concentrations and in reducing the total number of units of RBCs they require.

A new physiologic monitor for use in the home has been developed and used for the Collaborative Home Infant Monitor Evaluation (CHIME). This monitor measures infant breathing by respiratory inductance plethysmography and transthoracic impedance; infant electrocardiogram, heart rate and R-R interval; haemoglobin O2 saturation of arterial blood at the periphery and sleep position. Monitor signals from a representative sample of 24 subjects from the CHIME database were of sufficient quality to be clinically interpreted 91.7% of the time for the respiratory inductance plethysmograph, 100% for the ECG, 99.7% for the heart rate and 87% for the 16 subjects of the 24 who used the pulse oximeter. The monitor detected breaths with a sensitivity of 96% and a specificity of 65% compared to human scorers. It detected all clinically significant bradycardias but identified an additional 737 events where a human scorer did not detect bradycardia. The monitor was considered to be superior to conventional monitors and, therefore, suitable for the successful conduct of the CHIME study.

Study Objectives: Epoch lengths from 20 seconds to 1 minute, and smoothing strategies from zero to three minutes are encountered in the infant sleep and waking literature. The present study systematically examined the impact of various epoch lengths and smoothing strategies on infant sleep state architecture. Design: Overnight polysomnographic recordings were visually assessed by epoch as wake or as each of four sleep state parameters: electroencephalographic patterns, respiration, body movement, and eye movement. From these findings, sleep and waking states were assigned for each of six combinations of epoch length (30-second or 1-minute) and smoothing window length (none, 3-epoch, or 5-epoch). Setting: N/A Participants: Subjects were 91 term infants, 42-46 weeks postconceptional age, from the Collaborative Home Infant Monitoring Evaluation (CHIME) study. Interventions: N/A Measurements and Results: A greater epoch length resulted in more active and less quiet sleep as a percentage of total study; however, the size of the smoothing window did not affect the percentage of sleep/waking states. In general, the greater the epoch length and the greater the smoothing window length, the fewer the number of, the greater the mean duration of, and the greater the longest continuous episode of sleep/waking states. Analysis of significant interactions indicated that a 1-minute epoch length relative to a 30-second epoch length resulted in increasingly longer episodes of quiet and especially active sleep with a greater smoothing window length. Conclusions: Smoothing strategy significantly altered sleep state architecture in infants and may explain part of the variability in infant sleep state findings between laboratories.

As part of the Collaborative Home Infant Monitoring Evaluation (CHIME) we compared apnea identified by a customized home monitor using respiratory inductance plethysmography (RIP) with simultaneously recorded polysomnography-acquired nasal end-tidal CO2 (Pet CO2 ) and nasal/oral thermistor in 422 infants during overnight laboratory recordings to determine concordance between techniques, sources of disagreement, and capacity of RIP to detect obstructed breaths within an apnea. Among 233 episodes of apnea identified by at least one method as ⩾ 16 s, 120 were observed by the CHIME monitor, 219 by Pet CO2 , and 163 by thermistor. The positive predictive value of the CHIME-identified apnea was 89.2% (95% CI 83, 95) and 73% (95% CI 65, 81) for Pet CO2 and thermistor, respectively. However, the sensitivity of the CHIME monitor in identifying events detected by the other methods was only ∼ 50%. Among 87 apnea events identified by all three techniques, no two methods showed high agreement in measurement of apnea d...

Limitations in home monitoring technology have precluded longitudinal studies of hemoglobin oxygen saturation during unperturbed sleep. The memory monitor used in the Collaborative Home Infant Monitoring Evaluation addresses these limitations. We studied 64 healthy term infants at 2 to 25 weeks of age. We analyzed hemoglobin oxygen saturation by pulse oximetry (SpO(2)), respiratory inductance plethysmography, heart rate, and sleep position during 35, 127 epochs automatically recorded during the first 3 minutes of each hour. For each epoch baseline SpO(2) was determined during >/=10 s of quiet breathing. Acute decreases of at least 10 saturation points and /=5 s were identified, and the lowest SpO(2) was noted. The median baseline SpO(2) was 97.9% and did not change with age or sleep position. The baseline SpO(2) was /=16% were associated with isolated apnea. With the use of multivariate analyses, the odds of having an acute decrease increased as the number of epochs with periodic breathing increased, and they lessened significantly with age. We conclude that healthy infants generally have baseline SpO(2) levels >95%. The transient acute decreases are correlated with younger age, periodic breathing, and apnea and appear to be part of normal breathing and oxygenation behavior.

There are numerous reports of cardiorespiratory patterns in infants on home monitors, but no data to determine whether "experts" agree on the description of these patterns. Therefore, we evaluated agreement among four experienced investigators and five trained technicians who assessed independently the same sample of physiologic waveforms recorded from infants enrolled in a multicenter study. The monitor used respiratory inductance plethysmography and recorded waveforms for apnea > or = 16 s or a heart rate or = 5 s. The investigators and technicians initially assessed 88 waveforms. After additional training, the technicians assessed another 113 additional waveforms. In categorizing waveforms as apnea present or absent, agreement among technicians improved considerably with additional training (kappa 0.65 to 0.85). For categorizing waveforms as having bradycardia present versus absent, the trends were the same. Agreement in measurement of apnea duration also improved considerably with additional training (intraclass correlation 0.33-0.83). Agreement in measurement of bradycardia duration was consistently excellent (intraclass correlation 0.86-0.99). Total agreement was achieved among technicians with additional training for measurement of the lowest heart rate during a bradycardia. When classifying apnea as including > or = 1, > or = 2, > or = 3, or > or = 4 out-of-phase breaths, agreement was initially low, but after additional training it improved, especially in categorization of apneas with > or = 3 or > or = 4 out-of-phase breaths (kappa 0.67 and 0.94, respectively). Although researchers and clinicians commonly describe events based on cardiorespiratory recordings, agreement amongst experienced individuals may be poor, which can confound interpretation. With clear guidelines and sufficient training raters can attain a high level of agreement in describing cardiorespiratory events.