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A narrative review of randomized, blinded, controlled studies assessing the antipyretic effect of ibuprofen versus acetaminophen or combined or alternating treatment in children was conducted.Searches of the PubMed and Embase literature databases were conducted to identify relevant articles. Selected articles were limited to studies published in English that investigated OTC oral tablet and syrup formulations of acetaminophen and ibuprofen; there were no publication date limits. Open-label studies, nonrandomized studies, and those evaluating intravenous or suppository formulations of acetaminophen or ibuprofen were excluded. Variations in designs, endpoints, methods, and patient populations precluded our ability to conduct a formal systematic review.At physician-directed dosing (acetaminophen 15 mg/kg vs ibuprofen 10 mg/kg), no significant differences in antipyretic effects from 0‒6 h and between 0‒6, ‒12, ‒24, or ‒48 h, with single or multiple-doses, respectively, were observed. Tolerability profiles at physician dosing were similar. In 14 over-the-counter dose comparisons (acetaminophen, 10-15 mg/kg; ibuprofen, 2.5-10 mg/kg), antipyresis favored ibuprofen in 6, was similar between groups in 7, and favored acetaminophen (15 mg/kg vs ibuprofen 5 mg/kg) in 1 comparison. Both medications were well tolerated. Efficacy favored combination over individual components in 3 of 4 studies; alternating use results were mixed. All combination or alternating treatments were well tolerated.Antipyretic effects of ibuprofen and acetaminophen are similar at physician-directed doses; ibuprofen may be modestly superior at over-the-counter doses.

Newborns with neonatal abstinence syndrome (NAS) display symptoms related to neurologic excitability and autonomic dysfunction that result in increased metabolic demands. These infants also exhibit feeding difficulties and/or hyperphagia. Because the effects of these symptoms and behaviors on growth are unknown, we sought to measure serial body composition measurements over the first 4 months in infants with NAS requiring pharmacologic treatment using air displacement plethysmography. Fourteen infants of singleton birth with appropriate-for-gestational-age (AGA) weight and a gestational age of ≥35 weeks and N = 5) requiring multidrug therapy for symptom control had lower mean fat percent (−1.2%, CI: −5.2–2.1), fat mass (−60 g, CI: −25–13), and fat-free mass (−270 g, CI: −610–80) across time compared to infants requiring monotherapy. We are the first to report how body composition measures change over time in a small group of patients with NAS. Infants with NAS were smaller and leaner in the first several weeks compared to previously reported body composition measurements in term infants, but grew similarly to their healthy counterparts by 16 weeks. Infants with more severe NAS may be at risk for abnormalities in longer term growth.

Objectives Previous research has demonstrated that accidental unsupervised ingestions (AUIs) were responsible for the majority of cough and cold medication (CCM) ingestions leading to significant adverse events (AEs) in children. The objective of this analysis was to characterize the role of AUIs in the morbidity associated with CCM exposure in children. Methods This surveillance study collected data from 5 United States data sources from 2009 to 2016, in children younger than 6 years with an AE from an AUI involving at least 1 CCM over-the-counter pharmaceutical ingredient. An expert panel reviewed each case to determine causality. Results From 4756 total cases reviewed, 3134 (65.9%) had an AE from an AUI determined to be at least potentially related to a CCM ingredient. The majority (61.3%) of cases occurred in children aged 2 to younger than 4 years. Most exposures occurred in the child's own residence (94.9%), and 43.8% were admitted to a health care facility (22.0% to a critical care unit). Dextromethorphan and diphenhydramine, when packaged alone or in combination products, contributed to 96.0% of AUIs. The most common specific products involved were single-ingredient pediatric liquid diphenhydramine (30.1%) and single-ingredient pediatric liquid dextromethorphan (21.4%). There were 3 deaths from solid diphenhydramine formulations. Conclusions There continues to be opportunities for the implementation of interventions to prevent AUIs of CCM in children. Additional emphasis on engineering controls, such as flow restrictors for liquid formulations targeting diphenhydramine and dextromethorphan products, represent additional opportunities to further reduce AEs from AUIs of CCM.

Medication administration errors that take place in the home are common, especially when liquid preparations are used and complex medication schedules with multiple medications are involved; children with chronic conditions are disproportionately affected. Parents and other caregivers with low health literacy and/or limited English proficiency are at higher risk for making errors in administering medications to children in their care. Recommended strategies to reduce home medication errors relate to provider prescribing practices; health literacy–informed verbal counseling strategies (eg, teachback and showback) and written patient education materials (eg, pictographic information) for patients and/or caregivers across settings (inpatient, outpatient, emergency care, pharmacy); dosing-tool provision for liquid medication measurement; review of medication lists with patients and/or caregivers (medication reconciliation) that includes prescription and over-the-counter medications, as well as vitamins and supplements; leveraging the medical home; engaging adolescents and their adult caregivers; training of providers; safe disposal of medications; regulations related to medication dosing tools, labeling, packaging, and informational materials; use of electronic health records and other technologies; and research to identify novel ways to support safe home medication administration.

BACKGROUND AND OBJECTIVES In 2008, over-the-counter cough and cold medications (CCMs) underwent labeling changes in response to safety concerns, including fatalities, reported in children exposed to CCMs. The objective of this study is to describe fatalities associated with exposures to CCMs in children METHODS Fatalities in children RESULTS Of the 180 eligible fatalities captured during the study period, 40 were judged by the expert panel to be either related or potentially related to the CCM. Of these, the majority (n = 24; 60.0%) occurred in children CONCLUSIONS Pediatric fatalities associated with CCMs occurred primarily in young children after deliberate medication administration with nontherapeutic intent by a caregiver.

Significance Mitochondria frequently carry different DNA—a state called heteroplasmy. Heteroplasmic mutations can cause mitochondrial diseases and are involved in cancer and aging, but they are also common in healthy people. Here, we study heteroplasmy in 96 multigenerational healthy families. We show that mothers effectively transmit very few mitochondrial DNA to their offspring. Because of this bottleneck, which intensifies with increasing maternal age at childbirth, mutation frequencies can change dramatically between a mother and her child. Thus, a child might inherit a disease-causing mutation at high frequency from an asymptomatic carrier mother and might develop a disease. We also demonstrate that natural selection acts against disease-causing mutations during germline development. Our study has important implications for genetic counseling of mitochondrial diseases., Heteroplasmy—the presence of multiple mitochondrial DNA (mtDNA) haplotypes in an individual—can lead to numerous mitochondrial diseases. The presentation of such diseases depends on the frequency of the heteroplasmic variant in tissues, which, in turn, depends on the dynamics of mtDNA transmissions during germline and somatic development. Thus, understanding and predicting these dynamics between generations and within individuals is medically relevant. Here, we study patterns of heteroplasmy in 2 tissues from each of 345 humans in 96 multigenerational families, each with, at least, 2 siblings (a total of 249 mother–child transmissions). This experimental design has allowed us to estimate the timing of mtDNA mutations, drift, and selection with unprecedented precision. Our results are remarkably concordant between 2 complementary population-genetic approaches. We find evidence for a severe germline bottleneck (7–10 mtDNA segregating units) that occurs independently in different oocyte lineages from the same mother, while somatic bottlenecks are less severe. We demonstrate that divergence between mother and offspring increases with the mother’s age at childbirth, likely due to continued drift of heteroplasmy frequencies in oocytes under meiotic arrest. We show that this period is also accompanied by mutation accumulation leading to more de novo mutations in children born to older mothers. We show that heteroplasmic variants at intermediate frequencies can segregate for many generations in the human population, despite the strong germline bottleneck. We show that selection acts during germline development to keep the frequency of putatively deleterious variants from rising. Our findings have important applications for clinical genetics and genetic counseling.

Objective This study was undertaken to assess the potential value of preoperative blood components as prognostic markers of outcome after lung cancer resection, and hence their potential to aid in the selection of patients for curative surgery. Methods This was a single-center study on 313 patients who underwent surgery for non-small-cell lung cancer from 2006 to 2008. Data were analyzed retrospectively from a prospectively maintained thoracic database. Preoperative blood results including plasma fibrinogen levels, serum C-reactive protein, hemoglobin concentration, and platelet count were included in the analysis. Results The mean age was 75 years, and 40% of the patients were females. The most common resection was lobectomy in 68% of patients, followed by pneumonectomy, wedge resection, and segmentectomy in 18%, 10%, and 1.6%, respectively. Patients with abnormal C-reactive protein, fibrinogen, and hemoglobin levels had a worse overall survival. Large tumor size and nodal metastasis on clinical staging was also associated with poor survival. However, on Cox regression analysis, plasma fibrinogen and nodal metastasis were the only independent predictors of survival after lung resection. Conclusions Among the different blood markers, elevated preoperative plasma fibrinogen was an independent marker of reduced survival in patients with resected non-small-cell lung cancer, and its value in selecting patients who may benefit from surgery needs further investigation.

Despite the known benefits of breastmilk, associations between breastfeeding and child overall health outcomes remain unclear. We aimed to understand associations between breastfeeding and health outcomes, including child weight, through age 3. Analysis included women (N = 3006) in the longitudinal, prospective First Baby Study from 2009 to 2014. For this analysis, breastfeeding initiation and duration were measured using self-reported data from the 1-, 6- and 12-month surveys; child illnesses were analyzed from the 6-, 12-, and 24-month interviews; height and weight at age 3 were used to determine overweight/obese (≥85th percentile) and obese (≥95th percentile). Adjusted logistic regressions were utilized to determine significance. Greater duration of breastfeeding was associated with fewer reported acute illnesses at 6 months (p 0.001) and fewer diarrheal illness/constipation episodes at 6, 12, and 24 months (p = 0.05) in adjusted analyses. Fewer breastfed children, compared to non-breastfed children, were overweight/obese (23.5% vs. 37.8%; p = 0.032) or obese (9.1% vs. 21.6%; p = 0.012) at age 3. Breastfeeding duration was negatively associated with overweight/obese (never breastfed: 37.8%, 0-6 months: 26.9%,6 months: 20.2%; p = 0.020) and obesity (never breastfed: 21.6%, 0-6 months: 11.0%,6 months: 7.3%; p = 0.012). Overall, our findings support the hypothesis that duration of breastfeeding is associated with fewer reported acute illnesses at 6 months of age and diarrheal illness and/or constipation episodes at 6, 12, and 24 months. Additionally, results from our study suggest a protective effect of breastfeeding from childhood overweight/obesity, as children who received breastmilk for 6 months or longer had lower odds of overweight/obesity at age 3 years.

Background Maternal glucose intolerance during pregnancy has been associated with developmental delays and impairments in offspring including worse motor function and a greater likelihood of inattention and/or hyperactivity. The First Baby Study recruited an observational cohort 3006 women during their first pregnancy and followed maternal-child dyads for 3 years. We sought to evaluate associations between diabetes during pregnancy and subjective concern for developmental delay among offspring at ages …

An amendment to this paper has been published and can be accessed via the original article.

BACKGROUND / AIMS: When conducting clinical trials comparing over-the-counter (OTC) medications, the wide availability of these treatments are a potential challenge to maintaining study integrity. We seek to describe adherence to a study protocol involving widely available OTC medications. METHODS: To prospectively evaluate associations between acetaminophen use and asthma in 300 children aged 1–5 years, we conducted a double blind, randomized, controlled trial where parents administered blinded forms of either acetaminophen or ibuprofen as needed to their children over a 48 week period. Written and verbal instructions encouraged the exclusive use of the blinded study medication and discouraged OTC use. Adherence was determined by evaluating the frequency of use of per-protocol blinded study medication compared to off-protocol use of OTC medications. RESULTS: 4,195 doses of acetaminophen or ibuprofen were received by children during the study which included 3,664 doses (87.3%) of blinded study medication adhering to the protocol and 531 doses (12.7%) of OTC products deviating from the protocol with better adherence among those randomized to ibuprofen as compared to acetaminophen (89.5% vs. 85.5% of doses, p

Initial research following regulatory changes addressing the pediatric safety of cough and cold medications (CCMs) demonstrated decreases in adverse events (AEs). Using a national multi-source surveillance system, we studied subsequent CCM-related AE case rate trends and associated health-care facility (HCF) evaluation in children.Data were collected from 2009 to 2016. Case eligibility included: age12 years; exposure to an over-the-counter product containing ≥1 CCM pharmaceutical ingredient; ≥1 significant AE that occurred in the United States.About 4756 (72.6%) cases were determined at least potentially related to an index ingredient. Accidental unsupervised ingestions (AUIs; 3134; 65.9%) were the most common case type. Nearly half of AE cases involved children 2 to4 years old (2,159; 45.4%). The AE case rate did not change significantly over time (The proportion of AE cases resulting in HCF admission increased from 2009 to 2016. Efforts to prevent AUIs such as packaging innovation and engineering controls, particularly for diphenhydramine and dextromethorphan-containing products, should be pursued.

BACKGROUND Socioeconomically disadvantaged newborns receive care from primary care providers (PCPs) and Women, Infants, and Children (WIC) nutritionists. However, care is not coordinated between these settings, which can result in conflicting messages. Stakeholders support an integrated approach that coordinates services between settings with care tailored to patient-centered needs. OBJECTIVE This analysis describes the usability of advanced health information technologies aiming to engage parents in self-reporting parenting practices, integrate data into electronic health records to inform and facilitate documentation of provided responsive parenting (RP) care, and share data between settings to create opportunities to coordinate care between PCPs and WIC nutritionists. METHODS Parents and newborns (dyads) who were eligible for WIC care and received pediatric care in a single health system were recruited and randomized to a RP intervention or control group. For the 6-month intervention, electronic systems were created to facilitate documentation, data sharing, and coordination of provided RP care. Prior to PCP visits, parents were prompted to respond to the Early Healthy Lifestyles (EHL) self-assessment tool to capture current RP practices. Responses were integrated into the electronic health record and shared with WIC. Documentation of RP care and an 80-character, free-text comment were shared between WIC and PCPs. A care coordination opportunity existed when the dyad attended a WIC visit and these data were available from the PCP, and vice versa. Care coordination was demonstrated when WIC or PCPs interacted with data and documented RP care provided at the visit. RESULTS Dyads (N=131) attended 459 PCP (3.5, SD 1.0 per dyad) and 296 WIC (2.3, SD 1.0 per dyad) visits. Parents completed the EHL tool prior to 53.2% (244/459) of PCP visits (1.9, SD 1.2 per dyad), PCPs documented provided RP care at 35.3% (162/459) of visits, and data were shared with WIC following 100% (459/459) of PCP visits. A WIC visit followed a PCP visit 50.3% (231/459) of the time; thus, there were 1.8 (SD 0.8 per dyad) PCP to WIC care coordination opportunities. WIC coordinated care by documenting RP care at 66.7% (154/231) of opportunities (1.2, SD 0.9 per dyad). WIC visits were followed by a PCP visit 58.9% (116/197) of the time; thus, there were 0.9 (SD 0.8 per dyad) WIC to PCP care coordination opportunities. PCPs coordinated care by documenting RP care at 44.0% (51/116) of opportunities (0.4, SD 0.6 per dyad). CONCLUSIONS Results support the usability of advanced health information technology strategies to collect patient-reported data and share these data between multiple providers. Although PCPs and WIC shared data, WIC nutritionists were more likely to use data and document RP care to coordinate care than PCPs. Variability in timing, sequence, and frequency of visits underscores the need for flexibility in pragmatic studies. CLINICALTRIAL ClinicalTrials.gov NCT03482908; https://clinicaltrials.gov/ct2/show/NCT03482908 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12887-018-1263-z

Background With increased use of telehealth, interventions to improve infant sleep environments have not been explored. This study sought to assess the feasibility and efficacy of using electronic health record patient portals to transmit photographs of infant sleep between mothers and healthcare professionals as part of an intervention to promote sleep environments consistent with AAP guidelines. Methods One hundred eighty-four mother-newborn dyads consented to participate in a randomized trial requiring patient portal registration within 1 month of delivery. We first assessed feasibility as measured by a) the proportion of consented mothers enrolling in the portal and b) maternal adherence to prompts to submit photographs of their infant sleeping to the research team through the patient portal. Intervention group mothers were prompted at 1 and 2 months; controls were prompted only at 2 months. Efficacy was determined via research assistant review of submitted photographs. These assistants were trained to detect sudden unexplained infant death risk factors utilizing AAP guidelines. Standardized feedback was returned to mothers through the patient portal. We used Fisher’s Exact test to assess group differences in guideline adherence at 2 months. Results One hundred nine mothers (59%) enrolled in the patient portal and were randomized to intervention (N = 55) and control (N = 54) groups. 21 (38, 95% CI 25–52%) intervention group participants sent photographs at 1 month and received personalized feedback. Across both groups at 2 months, 40 (37, 95% CI 28–46%) sent photographs; 56% of intervention group participants who submitted photographs met all safe sleep criteria compared with 46% of controls (difference 0.10, 95% CI − 0.26 to 0.46, p = .75). Common reasons for guideline non-adherence were sleeping in a room without a caregiver (43%), loose bedding (15%) and objects (8%) on the sleep surface. Conclusions Utilizing the patient portal to individualize safe infant sleep is possible, however, we encountered numerous barriers in this trial to assess its effects on promoting safe infant sleep. Photographs of infants sleeping showed substantial non-adherence to AAP guidelines, suggesting further needs for improvement to promote safe infant sleep practices. Trial registration Name: Improving Infant Sleep Safety With the Electronic Health Record; Clinicaltrials.gov: NCT03662048; Date of Registration: September 7, 2018; Data Sharing Statement: None

Objectives This study aimed to determine whether personal protective equipment (PPE) results in deterioration in chest compression (CC) quality and greater fatigue for administering health care providers (HCPs). Methods In this multicenter study, HCPs completed 2 sessions. In session 1 (baseline), HCPs wore normal attire; in session 2, HCPs donned full PPE. During each session, they performed 5 minutes of uninterrupted CCs on a child manikin. Chest compression rate, depth, and release velocity were reported in ten 30-second epochs. Change in CC parameters and self-reported fatigue were measured between the start and 2- and 5-minute epochs. Results We enrolled 108 HCPs (prehospital and in-hospital providers). The median CC rate did not change significantly between epochs 1 and 10 during baseline sessions. Median CC depth and release velocity decreased for 5 minutes with PPE. There were no significant differences in CC parameters between baseline and PPE sessions in any provider group. Median fatigue scores during baseline sessions were 2 (at start), 4 (at 2 minutes), and 6 (at 5 minutes). There was a significantly higher median fatigue score between 0 and 5 minutes in both study sessions and in all groups. Fatigue scores were significantly higher for providers wearing PPE compared with baseline specifically among prehospital providers. Conclusions During a clinically appropriate 2-minute period, neither CC quality nor self-reported fatigue worsened to a significant degree in providers wearing PPE. Our data suggest that Pediatric Basic Life Support recommendations for CC providers to switch every 2 minutes need not be altered with PPE use.

Background Women with elevated body mass index are encouraged to lose weight before pregnancy, but no trials have tested the effects of prepregnancy weight loss on health outcomes. Objective This study aimed to determine whether prepregnancy weight loss reduces gestational weight gain and improves pregnancy outcomes. Study Design Pragmatic randomized clinical trial was conducted between May 2015 and October 2019 at Kaiser Permanente Northwest, an integrated health system. Data collection was blind to condition assignment. Eligible participants were women aged 18 to 40 years with a body mass index of ≥27 kg/m2 who were planning pregnancy within 2 years. Recruitment contacts were sent to 27,665 health system members who met age and body mass index criteria; 329 women attended screening visits, and 326 were randomized. They were randomized to either a behavioral weight loss intervention or usual care control. The intervention consisted of health coaching phone sessions weekly for 6 months and then monthly for 18 months or until end of pregnancy. We used logistic regression to examine the a priori primary hypothesis that participants in the intervention would be less likely to exceed National Academy of Medicine guidelines for gestational weight gain during each trimester and overall. Secondary and exploratory outcomes included absolute weight gain before and during pregnancy and perinatal and newborn outcomes. Results Of the 326 participants, 169 had singleton pregnancies lasting ≥14 weeks (analytical cohort: intervention, 89; control, 80). At baseline, mean age was 31.3±3.5 years, and body mass index was 34.8±5.8 kg/m2. Participants in the intervention group lost more weight before pregnancy than those in the control group (−0.25±0.51 vs −0.03±0.21 kg/wk; P Conclusion Participation in the prepregnancy weight loss intervention had no effect on women’s likelihood of exceeding gestational weight gain guidelines. Although the intervention group successfully lost weight before conception, the intervention group was associated with greater weight gain in late pregnancy. To effectively reduce weight throughout pregnancy and improve maternal and child outcomes, prepregnancy weight loss interventions may need to be combined with intensive weight management that continues throughout delivery.

BACKGROUND: Although sleep duration is a risk factor for obesity in young children, less is known about other aspects of sleep health, including bedtime, on obesity risk. OBJECTIVE: To determine whether bedtime is associated with body mass index (BMI) z-score or obesity risk in children ages 2 to 5 years, and to determine if associations are independent of sleep duration. METHODS: Cohort analyses were undertaken using three early life obesity prevention trials (POI, INSIGHT, Healthy Beginnings) and a longitudinal cohort study (HOME). Bedtime was assessed by questionnaire and BMI through clinical measurement between 2 and 5 years in 1642 children. Adjusted regression models examined whether BMI z-score and obesity (BMI z-score ≥ 2) were associated with bedtime, nocturnal sleep time and 24-hour sleep time. A discrete mixture model categorized children into bedtime trajectory groups across time points. RESULTS: Bedtime was inconsistently associated with BMI z-score. Although each hour later of bedtime was associated with greater odds of obesity at ages 3 (OR; 95% CI: 1.05; 1.003, 1.10) and 5 (1.35; 1.08, 1.69) years, odds were attenuated after adjustment for nocturnal or 24-hour sleep time. Longer nocturnal sleep duration at 2 years was associated with lower odds of obesity (OR 0.90; 0.86, 0.94), as was longer 24-hour sleep duration at 3 years in girls (0.70; 0.62, 0.78). BMI z-score and odds of obesity were not significantly different between ‘early to bed’ and ‘late to bed’ trajectory groups. CONCLUSIONS: Timing of bedtime appears inconsistently related to obesity in young children, possibly via influencing overall sleep duration.

Key Points Question Is cesarean delivery at first childbirth associated with a lower rate of subsequent conception compared with vaginal delivery? Findings In this cohort study of 2423 women, first childbirth by cesarean delivery was associated with a lower rate of conception after unprotected intercourse when compared with conception rates of women after vaginal delivery. These results remained significant after controlling for relevant covariates. Meaning These findings suggest that women who deliver their first child by cesarean delivery may be less likely to conceive a second child in the 3 years following first delivery than women who deliver their first child vaginally., This cohort study examines the association of first childbirth by cesarean vs vaginal delivery with rates of subsequent conceptions and live births among US women., Importance More than 20% of births globally are by cesarean delivery, including more than 30% in the US. Prior studies have reported lower rates of childbearing after cesarean delivery, but it is not clear if this is due to maternal choice or lower conception rates. Objective To investigate the association between mode of first delivery and subsequent conceptions and live births. Design, Setting, and Participants The First Baby Study was a multicenter prospective cohort study of women aged 18 to 35 years with singleton pregnancies, enrolled and interviewed before first childbirth, who delivered in Pennsylvania from 2009 to 2011 and were followed up for 36 months after delivery (until April 2014). Data analysis for this study took place between May and July 2019 and in January 2020. Exposures Mode of first delivery (cesarean or vaginal). Main Outcomes and Measures Rates of subsequent conceptions and live births. Discrete-time Cox proportional hazard regression models were used to compare the rate of subsequent conception (vaginal vs cesarean) among those who completed the 36-month survey, accounting for reported months of unprotected intercourse during the follow-up period and adjusting for relevant covariates. A log binomial regression was used to compare the age-adjusted rate of subsequent live birth (vaginal vs cesarean) among those who completed the 36-month survey. Results The study population consisted of 2423 women who were retained to the 36-month survey (mean [SD] age at baseline was 27.2 [4.4] years and 712 [29.4%] delivered by cesarean). There were 2046 women who had unprotected intercourse during the follow-up period, 2021 of whom provided data on months of unprotected intercourse. Cesarean delivery was associated with lower rates of conception after unprotected intercourse during the follow-up period (413 of 599 [68.9%]) compared with vaginal delivery (1090 of 1422 [76.7%]) (adjusted hazard ratio, 0.85; 95% CI, 0.74-0.96). Cesarean delivery was also associated with reduced likelihood of a subsequent live birth (305 women [42.8%]) compared with vaginal delivery (857 women [50.1%]), with an age-adjusted risk ratio of 0.83 (95% CI, 0.75-0.92). Conclusions and Relevance In the 3 years following first childbirth, women who delivered their first child by cesarean had lower rates of conception after unprotected intercourse, and fewer of these women had a second child than those who delivered vaginally.

Diabetes mellitus (DM) is a leading risk factor for aging-related dementia; however, the underlying mechanisms are not well understood. The present study, utilizing a non-obese T2DN diabetic model, demonstrates that the myogenic response of the middle cerebral artery (MCA) and parenchymal arteriole (PA) and autoregulation of cerebral blood flow (CBF) in the surface and deep cortex were impaired at both young and old ages. The impaired CBF autoregulation was more severe in old than young DM rats, and in the deep than the surface cortex. The myogenic tone of the MCA was enhanced at perfusion pressure in the range of 40–100 mmHg in young DM rats but was reduced at 140–180 mmHg in old DM rats. No change of the myogenic tone of the PA was observed in young DM rats, whereas it was significantly reduced at 30–60 mmHg in old DM rats. Old DM rats had enhanced blood-brain barrier (BBB) leakage and neurodegeneration, reduced vascular density, tight junction, and pericyte coverage on cerebral capillaries in the CA3 region in the hippocampus. Additionally, DM rats displayed impaired functional hyperemia and spatial learning and short- and long-term memory at both young and old ages. Old DM rats had impaired non-spatial short-term memory. These results revealed that impaired CBF autoregulation and enhanced BBB leakage plays an essential role in the pathogenesis of age- and diabetes-related dementia. These findings will lay the foundations for the discovery of anti-diabetic therapies targeting restoring CBF autoregulation to prevent the onset and progression of dementia in elderly DM.

BACKGROUND In recent years, there has been increasing recognition of the importance of early maternal-newborn contact for the health and well-being of the newborn and promotion of breastfeeding. However, little research has investigated the association between early maternal-newborn contact and the mother's birth experience. METHODS As part of a large-scale prospective, cohort study (the First Baby Study [FBS]), nearly 3000 women who delivered in Pennsylvania (2009-2011) reported how soon after delivery they first saw, held, and fed their newborns. Birth experience was measured via telephone interview 1 month postpartum, using the FBS Birth Experience Scale, a 16-item scale which addresses women's feelings about the delivery. General linear models were used to measure associations between time to first maternal-newborn contact and birth experience, controlling for relevant confounders, including maternal age, race/ethnicity, insurance coverage, delivery mode, gestational age, and pregnancy and delivery complications. RESULTS The sooner that new mothers first saw, held, and fed their newborns after delivery the more positive their childbirth experiences (all P-values

Background What, when, how, how much, and how often infants are fed have been associated with childhood obesity risk. The objective of this secondary analysis was to examine the effect of a responsive parenting (RP) intervention designed for obesity prevention on parents’ infant feeding practices in the first year after birth. Methods Primiparous mother-newborn dyads were randomized to the Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study RP intervention or child safety control. Research nurses delivered intervention content at home at infant age 3–4, 16, 28, and 40 weeks, and at a research center at 1 year. RP feeding guidance advised feeding that was contingent (i.e., feed in response to hunger and satiety signs, alternatives to using food to soothe), and developmentally appropriate (i.e., delaying introduction of solids, age-appropriate portion sizes). Infant feeding practices (i.e., bottle use, introduction of solids, food to soothe) were assessed by phone interviews and online surveys and dietary intake was assessed using a food frequency questionnaire. Results RP mothers were more likely to use of structure-based feeding practices including limit-setting (p

Background:The study purposes were to examine (1) differences in postpartum exercise (EX) and related personal/psychological correlates in women according to prepregnancy weight and pregnancy gestational weight gain (GWG) status and (2) predictors of EX at 2 weeks, 2 months, and 6 months postpartum.Methods:Participants (N = 891) were recruited at maternity hospitalization and completed interviews to assess EX (Leisure-Time Exercise Questionnaire) and personal correlates (demographics, anxiety/depressive symptoms) before/during pregnancy. Telephone interviews were conducted to assess postpartum EX/psychological correlates. Women were categorized according to prepregnancy weight (normal and overweight) and pregnancy GWG status (above or within weight gain guidelines): normal-above, normal-within, overweight-above, and overweight-within.Results:Low levels of EX minutes were observed in all women with significant differences for strenuous EX minutes (overweight-within women had the lowest strenuous EX; normal-weight women had more strenuous EX than overweight women regardless of GWG). Correlates explained 14%–37% of the variance in postpartum EX; prepregnancy EX and pregnancy EX were strong determinants of early postpartum EX, and early postpartum EX predicted 6-month postpartum EX. Unique predictors of EX also emerged (eg, depressive symptoms for women with GWG above guidelines).Conclusions:These study findings highlight the benefits of EX before/during pregnancy for promoting postpartum EX and suggest tailoring postpartum EX interventions based on personal/psychological correlates to maximize effectiveness.

SummaryBackground Maternal psychological factors like depression, anxiety and stress have been associated with infant fussiness or colic. However, little research exists on whether positive factors such as social support and the happiness of the mother–partner relationship are associated with lower rates of infant fussiness or colic. Objectives We investigated the association between infant colic and three types of maternal support: general maternal social support (during pregnancy and post partum), the happiness of the mother–partner relationship (during pregnancy and post partum) and partner involvement in caring for the newborn. Methods Participants were 3006 women in the First Baby Study, a prospective study of the effect of mode of first delivery on subsequent childbearing. Women were interviewed by telephone during pregnancy and 1 month after first childbirth and asked about social support and if their baby had a variety of problems since birth, including ‘Colic – crying or fussiness three or more hours a day’. Multivariable logistic regression models were used to model the association between maternal support and infant colic, controlling for confounders, including maternal race or ethnicity, insurance, marital status, smoking, mode of delivery, maternal post-partum depression, breastfeeding, other neonatal illnesses and newborn gestational age. Results Infant colic was reported by 11.6% of new mothers. High general maternal social support (in comparison with low), measured during pregnancy, was associated with lower reported infant colic (adjusted odds ratio (AOR), 0.55, 95% confidence interval (CI), 0.40–0.75) and measured post partum (AOR, 0.51, 95% CI, 0.39–0.67); high relationship happiness (in comparison with low), measured during pregnancy (AOR, 0.71, 95% CI, 0.54–0.93), and measured post partum (AOR, 0.22, 95% CI, 0.12–0.40); and high partner involvement with newborn care (in comparison with low) (AOR, 0.60, 95% CI, 0.44–0.81). Conclusion Higher levels of maternal social support during pregnancy and post partum are associated with lower rates of maternal reported infant colic.

Until recently most of the scrutiny of opioid-containing cough and cold medications (CCMs) by the US Food and Drug Administration (FDA) was focused on codeine, only recently shifting equal focus to those containing hydrocodone. We characterized adverse events (AEs) in children12 years old associated with CCMs that include both an opioid and over-the-counter (OTC) ingredient.US cases from multiple sources collected as part of a safety surveillance program were included if AEs followed exposure to combination CCMs containing codeine or hydrocodone between January 2008 and December 2015. An expert panel reviewed cases to identify causal relationship between exposure and AEs and identify contributing factors. Each AE term was coded using the Medical Dictionary for Regulatory Activities with preferred terms reported.One hundred and fourteen of the 7035 (2%) cases reviewed involved an opioid-containing product. Ninety-eight cases involved an AE at least potentially related to the opioid ingredient (38 (39%) codeine; 60 (61%) hydrocodone). All three fatality cases involved hydrocodone with an antihistamine. Among non-fatalities, somnolence, lethargy, and/or respiratory depression were more commonly reported among hydrocodone cases than codeine cases (86% vs. 61%; p = .005).These safety surveillance data support the FDA's expanded label changes limiting opioid CCMs for children.

Background The Intervention Nurses Start Infant Growing on Healthy Trajectories (INSIGHT) study's responsive parenting (RP) intervention, initiated in early infancy, prevented the use of nonresponsive, controlling feeding practices and promoted use of structure-based feeding among first-time parents compared with controls. Objectives We sought to examine the spillover effect of the RP intervention on maternal feeding practices with their secondborn (SB) infants enrolled in an observational-only study, SIBSIGHT, and to test the moderating effect of spacing of births. Methods SB infants of mothers participating in the INSIGHT study were enrolled into the observation-only ancillary study, SIBSIGHT. SBs were healthy singleton infants ≥36 weeks of gestation. Infant feeding practices (i.e., food to soothe, structure vs. control-based practices) were assessed using validated questionnaires: Babies Need Soothing Questionnaire, Infant Feeding Styles Questionnaire, and the Structure and Control in Parent Feeding Questionnaire. Results SBs (n = 117 [RP: 57, control: 60]; 43% male) were delivered 2.5 ± 0.8 y after firstborns (FBs). At age 1 y, the Structure and Control in Parent Feeding Questionnaire revealed that the mothers in the RP group used more consistent feeding routines (4.19 [0.43] compared with 3.77 [0.62], P = 0.0006, Cohen's D: 0.69) compared with control group mothers. From the Infant Feeding Styles Questionnaire, RP group mothers also used less nonresponsive, controlling feeding practices such as pressuring their SB infant to finish (1.81 [0.52] compared with 2.24 [0.68], P = 0.001, Cohen's D: 0.68) compared with controls. In contrast to our hypotheses, no differences were detected in bottle-feeding practices such as putting to bed with a bottle/sippy cup or adding cereal to the bottle, despite observing study group differences in FBs. Spacing of births did not moderate intervention effects. Conclusions RP guidance given to mothers of FBs may prevent the use of some nonresponsive, controlling feeding practices while establishing consistent feeding routines in subsequent siblings.

Importance Breastfeeding through 6 and 12 months are 2 goals of the Centers for Disease Control and Prevention Healthy People 2020 initiative, but the 6-month goal is met for only 52% of US infants and the 12-month goal for 30% of US infants. Objective To determine whether structured, short-term formula supplementation for at-risk neonates affects the proportion still breastfeeding at 6 and 12 months. Design, Setting, and Participants This randomized clinical trial conducted at 2 US academic medical centers enrolled 164 exclusively breastfeeding mother-infant dyads of mothers who were not yet producing copious milk and infants who were 24 to 72 hours old with newborn weight loss at or above the 75th percentile for age. Participants were enrolled from January 2015 through September 2016. Interventions Early Limited Formula (ELF), a structured formula supplementation protocol (10 mL formula fed after each breastfeeding until mothers produced copious milk), compared with control dyads, who continued exclusive breastfeeding and received a safety teaching intervention. Main Outcomes and Measures The study’s primary outcome was any breastfeeding at 6 months. Secondary outcomes included age at breastfeeding cessation and any breastfeeding at 12 months. All outcomes were assessed by maternal phone survey. Results Eighty-two newborns were randomized to ELF and 82 to the control group. Mean (SD) maternal age was 31.4 (5.9) years, and 114 (69.5%) self-identified as non-Hispanic white; 20 (12.2%), Hispanic; 17 (10.4%), Asian; 5 (3.0%), non-Hispanic black; and 7 (4.3%), other. Compared with controls, mothers randomized to ELF were less likely to be married (n = 53 [64.6%] vs n = 66 [80.5%];P = .03) and had shorter mean (SD) intended duration of breastfeeding (8.6 [3.4] vs 9.9 [4.4] months;P = .049). Median (interquartile range) duration of breastfeeding in the cohort was 9 (6-12) months. At 6 months, 47 (65%) infants randomized to ELF were breastfeeding, compared with 60 (77%) of the control infants (absolute difference, –12%; 95% CI, –26% to 3%;P = .12). At 12 months, 21 of the 71 ELF infants available for analysis (29.6%) were breastfeeding, compared with 37 of the available 77 (48.1%) control infants (risk difference, –18%; 95% CI, –34% to –3%). Marital status and intended breastfeeding duration were both associated with breastfeeding duration; models adjusting for these found a hazard ratio for time-to-event of breastfeeding cessation through 12 months of 0.74 (95% CI, 0.48-1.14) for ELF infants compared with infants in the control group. Conclusions and Relevance In this cohort with high breastfeeding prevalence, ELF was not associated with any improvement in breastfeeding duration. Future research should examine the effect of ELF in populations at higher risk of early cessation. Trial Registration ClinicalTrials.gov identifier:NCT02313181

Out of hospital medication-related adverse events (AEs) from cough and cold medications (CCMs) can have significant public health impact. The objective of this study was to characterize pediatric medication error AEs involving over-the-counter (OTC) CCMs to identify preventable factors.Multisource national data surveillance system study using an expert panel evaluating CCM AEs related to medication errors.age12 years, and at least 1 significant AE from at least 1 index ingredient from a CCM OTC product.From 2009 through 2016, 4756 cases were determined to have a significant AE related to an OTC CCM ingredient and 513 (10.8%) cases were due to a medication error. Nearly half of medication errors involved children 2 to6 years old (n = 235; 45.8%). Many involved administration by a parent (n = 231; 45.0%) or alternative caregiver (n = 148; 28.8%). In nearly all cases (93.2%), the medication error involved the wrong dose of the medication. Health care facility evaluation occurred in 381 (74.3%) cases. Diphenhydramine and dextromethorphan were responsible for most medication errors and medication errors involving health care facility evaluation. There were no deaths from medication errors.In this multiyear surveillance study, medication errors most commonly occurred in children6 years old who received the wrong volume of a liquid product. Diphenhydramine and dextromethorphan dosing errors were the most common cause of medication errors resulting from CCM use. Continued standardization of measuring devices, concentrations, and units of measure along with consumer education are needed to further decrease medication errors from CCMs.

OBJECTIVE To determine whether a responsive parenting (RP) intervention affects infant dietary patterns. METHODS Primiparous mother-newborn dyads (n = 291) were randomized to the Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) RP intervention or control. Curricula were delivered at nurse home visits at ages 3, 16, 28, and 40 weeks. RP group feeding guidance advised responsive feeding, delayed introduction of solids, repeated exposure to novel foods, and age-appropriate portion sizes. Latent class analysis identified patterns of dietary exposure at 9 months. Class membership at 9 months was used to predict BMI percentile at 2 years. RESULTS Five dietary patterns were identified: "Breastfed, Fruits and Vegetables," "Breastfed, Low Variety," "Formula, Fruits and Vegetables," "Formula, Low Variety," and "Formula, High Energy Density." Over 60% of infants had patterns low in fruits and vegetables or high in energy-dense foods. RP group infants were less likely than control to be in the "Formula, Low Variety" class (OR = 0.40, 95% CI 0.23-0.71) or "Formula, High Energy Density" class (OR = 0.28, 95% CI 0.12-0.61) relative to the "Formula, Fruits and Vegetables" class. Dietary pattern at 9 months was significantly associated with BMI percentile at 2 years. CONCLUSIONS While a majority of infants consumed diets low in fruits and vegetables, the INSIGHT RP intervention was associated with healthier dietary patterns.

Dextromethorphan is the most common over-the-counter (OTC) antitussive medication. We sought to characterize adverse events associated with dextromethorphan in children12 years old from a surveillance program of OTC cough/cold medication exposures.This is a retrospective case series of oral exposures to dextromethorphan with ≥1 adverse event from multiple U.S. sources (National Poison Data System, FDA Adverse Event Reporting System, manufacturer safety reports, news/media, medical literature) reported between 2008 and 2014. An expert panel determined the relationship between exposure and adverse events, estimated dose ingested, intent of exposure, and identified contributing factors to exposure.1716 cases contained ≥1 adverse event deemed at least potentially related to dextromethorphan; 1417 were single product exposures. 773/1417 (55%) involved only one single-ingredient dextromethorphan product (dextromethorphan-only). Among dextromethorphan-only cases, 3% followed ingestion of a therapeutic dose; 78% followed an overdose. 69% involved unsupervised self-administration and 60% occurred in children4 years old. No deaths or pathologic dysrhythmias occurred. Central nervous system [e.g., ataxia (N = 420)] and autonomic symptoms [e.g., tachycardia (N = 224)] were the most common adverse events. Flushing and/or urticarial rash occurred in 18.1% of patients. Dystonia occurred in 5.4%.No fatalities were identified in this multifaceted surveillance program following a dextromethorphan-only ingestion. Adverse events were predominantly associated with overdose, most commonly affecting the central nervous and autonomic systems.

High frequency hearing loss (HFHL), often related to hazardous noise, affects one in six U.S. adolescents. Yet, only 20 states include school-based hearing screens for adolescents. Only six states test multiple high frequencies. Study objectives were to (1) compare the sensitivity of state school-based hearing screens for adolescents to gold standard sound-treated booth testing and (2) consider the effect of adding multiple high frequencies and two-step screening on sensitivity/specificity. Of 134 eleventh-grade participants (2013–2014), 43 of the 134 (32%) did not pass sound-treated booth testing, and 27 of the 43 (63%) had HFHL. Sensitivity/specificity of the most common protocol (1,000, 2,000, 4,000 Hz at 20 dB HL) for these hearing losses was 25.6% (95% confidence interval [CI] = [13.5, 41.2]) and 85.7% (95% CI [76.8, 92.2]), respectively. A protocol including 500, 1,000, 2,000, 4,000, 6,000 Hz at 20 dB HL significantly improved sensitivity to 76.7% (95% CI [61.4, 88.2]), p < .001. Two-step screening maintained specificity (84.6%, 95% CI [75.5, 91.3]). Adolescent school-based hearing screen sensitivity improves with high frequencies.

Background Invasive candidiasis (IC) is an important cause of sepsis in premature infants and is associated with a high risk of death and neurodevelopmental impairment. Prevention of IC has become a major focus in very low birth weight infants, with fluconazole increasingly used as prophylaxis. Methods We identified all randomized, placebo-controlled trials evaluating fluconazole prophylaxis in premature infants conducted in the United States. We obtained patient-level data from the study investigators and performed an aggregated analysis. The occurrence of each endpoint in infants who received prophylaxis with fluconazole vs placebo was compared. Endpoints evaluated were IC or death, IC, death, Candida colonization, and fluconazole resistance among tested isolates. Safety endpoints evaluated included clinical and laboratory parameters. Results Fluconazole prophylaxis reduced the odds of IC or death, IC, and Candida colonization during the drug exposure period compared with infants given placebo: odds ratios of 0.48 (95% confidence interval [CI], .30-.78), 0.20 (95% CI, .08-.51), and 0.28 (95% CI, .18-.41), respectively. The incidence of clinical and laboratory adverse events was similar for infants who received fluconazole compared with placebo. There was no statistically significant difference in the proportion of tested isolates that were resistant to fluconazole between the fluconazole and placebo groups. Conclusions Fluconazole prophylaxis is effective and safe in reducing IC and Candida colonization in premature infants, and has no impact on resistance.

Background Infants with neonatal abstinence syndrome (NAS) initially experience neurologic excitability, poor feeding, and/or hyperphagia in the setting of increased metabolic demand. Because the longitudinal effects of these early symptoms and behaviors on weight trends are unknown, we sought to contrast weight gain patterns through age 1 year for infants diagnosed with NAS with matched controls. Methods Retrospective cohort of 70 singletons with a gestational age of ≥37 weeks and an ICD-9 or ICD-10 diagnosis of NAS made ≤7 days after birth with institutional follow-up matched to patients without NAS. Infants were matched on gestational age (±2 weeks), birth weight (±20 g), sex (exact), and insurance type (exact). Quantile regression methods were used to estimate 10th, 25th, 50th, 75th and 90th percentiles of weight over time. Results The mean gestational age for an infant with NAS was 38.8 weeks (standard deviation [SD], 1.3). The mean birth weight was 3.141 kg (SD, 0.510). NAS patients had a median of 24 weights recorded between birth and 400 days (inter-quartile range [IQR], 16–32 weights). Patients without NAS had a median of 12 weights recorded (IQR, 10–16). Growth curves were similar over the first 400 days of life. Patients with NAS had non-significantly higher and lower estimated weights for the 90th and 10th percentiles, respectively. Conclusion Infants with a diagnosis of NAS grew similarly to controls during their first year. Given the frequently-encountered NAS symptoms of hyperphagia and irritability, future studies may evaluate whether early differences in caregiver feeding exist and whether they have longer-term impacts on growth.

Background Economically disadvantaged families receive care in both clinical and community settings, but this care is rarely coordinated and can result in conflicting educational messaging. WEE Baby Care is a pragmatic randomized clinical trial evaluating a patient-centered responsive parenting (RP) intervention that uses health information technology (HIT) strategies to coordinate care between pediatric primary care providers (PCPs) and the Special Supplemental Nutrition Program for Women, Infant and Children (WIC) community nutritionists to prevent rapid weight gain from birth to 6 months. It is hypothesized that data integration and coordination will improve consistency in RP messaging and parent self-efficacy, promoting shared decision making and infant self-regulation, to reduce infant rapid weight gain from birth to 6 months. Methods/design Two hundred and ninety mothers and their full-term newborns will be recruited and randomized to the “RP intervention” or “standard care control” groups. The RP intervention includes: 1) parenting and nutrition education developed using the American Academy of Pediatrics Healthy Active Living for Families curriculum in conjunction with portions of a previously tested RP curriculum delivered by trained pediatric PCPs and WIC nutritionists during regularly scheduled appointments; 2) parent-reported data using the Early Healthy Lifestyles (EHL) risk assessment tool; and 3) data integration into child’s electronic health records with display and documentation features to inform counseling and coordinate care between pediatric PCPs and WIC nutritionists. The primary study outcome is rapid infant weight gain from birth to 6 months derived from sex-specific World Health Organization adjusted weight-for-age z-scores. Additional outcomes include care coordination, messaging consistency, parenting behaviors (e.g., food to soothe), self-efficacy, and infant sleep health. Infant temperament and parent depression will be explored as moderators of RP effects on infant outcomes. Discussion This pragmatic patient-centered RP intervention integrates and coordinates care across clinical and community sectors, potentially offering a fundamental change in the delivery of pediatric care for prevention and health promotion. Findings from this trial can inform large scale dissemination of obesity prevention programs. Trial registration Restrospective Clinical Trial Registration: NCT03482908. Registered March 29, 2018.

Background The purpose of this report is to evaluate the quality of data sources used to study cough and cold medication (CCM) safety in children via the Pediatric Cough and Cold Safety Surveillance System. Methods The System utilized the National Poison Data System (NPDS), FDA Adverse Event Reporting System (FAERS), English-language medical literature, manufacturer postmarket safety databases, and news/media reports to identify cases from January 2008 through September 2016. Each data source was evaluated by the proportion of detected cases determined to be eligible (met case criteria) and the proportion determined to be evaluable (able to determine causal relationship between adverse event and exposure). Results A total of 7184 unique cases were identified from 27,597 detected reports. Of these, 6447 (89.7%) were evaluable. The data source with the highest volume of detected cases was news/media; however, only 0.3% of those cases were eligible for panel review and only 0.2% (24 out of 13,450 cases) were evaluable. The data source with the highest proportion of eligible and evaluable cases was NPDS with 7691 detected cases, 6113 (79.5%) eligible cases, and 5587 (72.6%) evaluable cases. Conclusions The data sources utilized to evaluate the safety profile of pediatric CCMs yielded variable detection and evaluation rates, but overall provided a comprehensive look at exposures that otherwise cannot be studied in clinical trials. While this study suggests that each source made a valuable contribution and that evaluable cases are generalizable, improvements are needed in case completeness and accuracy to enhance the quality of postmarket safety evaluations. Electronic supplementary material The online version of this article (10.1186/s12874-018-0626-3) contains supplementary material, which is available to authorized users.

INTRODUCTION: Factors that occur between consecutive pregnancies may influence repeated excessive gestational weight gain (GWG) and infants born large-for-gestational age (LGA). We examined inter-pregnancy interval, weight retention, and GWG in women’s 1(st) pregnancy as predictors of excessive GWG and LGA in women’s 2(nd) pregnancy. STUDY DESIGN: We used data from women’s first 2 live births during the First Baby Study, a 3-year prospective observational cohort of first-time mothers (N=549). GWG was calculated as weight at delivery minus pre-pregnancy weight for 1(st) and 2(nd) pregnancies and categorized using the Institute of Medicine guidelines. Weight retention at 6 and 12 months and inter-pregnancy interval (time from 1(st) live birth to conception of 2(nd) infant) were quantified. Infants were considered LGA if birthweight was ≥90(th) percentile for gestational age. RESULTS: Many (51.7%) women exceeded GWG recommendations in both pregnancies. Women who exceeded guidelines in their 1(st) pregnancy had 5.08 (p

Background Sedentary behaviors, including screen time, in childhood have been associated with an increased risk for overweight. Beginning in infancy, we sought to reduce screen time and television exposure and increase time spent in interactive play as one component of a responsive parenting (RP) intervention designed for obesity prevention. Methods The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study is a randomized trial comparing a RP intervention with a safety control intervention. Primiparous mother-newborn dyads (N = 279) were randomized after childbirth. Research nurses delivered intervention content at infant ages 3, 16, 28, and 40 weeks and research center visits at 1 and 2 years. As one component of INSIGHT, developmentally appropriate messages on minimizing screen time, reducing television exposure in the home, and promoting parent-child engagement through interactive play were delivered. Mothers self-reported their infant’s screen time at ages 44 weeks, 1, 1.5, 2 and 2.5 years; interactive play was reported at 8 and 20 weeks and 2 years. Results More RP than control parents reported their infants met the American Academy of Pediatrics’ no screen time recommendation at 44 weeks (53.0% vs. 30.2%) and at 1 year on weekdays (42.5% vs. 27.6%) and weekends (45.5% vs. 26.8%), but not after age 1 year. RP mothers and RP children had less daily screen time than controls at each time point (p ≤ 0.01). Fewer RP than control group mothers reported the television was ever on during infant meals (p

Objective To assess appropriate pantoprazole dosing for obese children, we conducted a prospective pharmacokinetics (PK) investigation of pantoprazole in obese children, a patient population that is traditionally excluded from clinical trials. Study design A total of 41 obese children (6-17 years of age), genotyped for CYP2C19 variants * 2, * 3, * 4, and * 17, received a single oral dose of pantoprazole, ~1.2 mg/kg lean body weight (LBW), with LBW calculated via a validated formula. Ten post-dose pantoprazole plasma concentrations were measured, and PK variables generated via noncompartmental methods (WinNonlin). Linear and nonlinear regression analyses and analyses of variance were used to explore obesity, age, and CYP2C19 genotype contribution to pantoprazole PK. PK variables of interest were compared with historic nonobese peers treated with pantoprazole. Results Independent of genotype, when normalized to dose per kg total body weight, pantoprazole apparent clearance and apparent volume of distribution were significantly lower ( P P Conclusions LBW dosing of pantoprazole led to pantoprazole PK similar to nonobese peers. Additional factors, other than body size (eg, age-related changes in CYP2C19 activity), appear to affect pantoprazole PK in children Trial registration ClinicalTrials.gov : NCT02186652

Exposure to unpredictable chronic mild stress (CUS) is a commonly used protocol in rats that is reported to evoke antidepressant-reversible behaviors such as loss of preference for a sweetened water solution which is taken as an analog of the anhedonia seen in major depression. However, the induction of anhedonic-like behavior by chronic mild stress, gauged by an animal's preference for sucrose solution, is not fully reproducible and consistent across laboratories. In this study, we compared a widely used behavioral marker of anhedonia - the sucrose preference test, with another phenotypic marker of emotional valence, social interaction-associated ultrasonic vocalizations as well as a marker of an anxiety-like phenotype, novelty-suppressed feeding, and cognitive performance in the eight arm radial maze task in adult male Sprague-Dawley rats. Chronic four-week exposure to unpredictable mild stressors resulted in 1) attenuation of social interaction-associated ultrasonic vocalizations 2) attenuation of spatial memory performance on the radial arm maze 3) attenuation of body weight gain and 4) increased latency to feed in a novelty-suppressed feeding task. However, chronic exposure to CUS did not result in any significant change in sucrose preference at one-week and three-week intervals. Our results argue for the utility of ultrasonic vocalizations in a social interaction context as a comparable alternative or adjunct to the sucrose preference test in determining the efficacy of CUS to generate an anhedonic-like phenotypic state.

To evaluate the impact of psychosocial stress during pregnancy on infant health outcomes in the first postnatal year. A sample of 3000 women completed a stress inventory (the Psychosocial Hassles Scale) during their third trimester before first childbirth. Infant health outcomes were measured via maternal report at 1, 6 and 12 months postpartum. Poisson regression was used to model the effect of maternal stress during pregnancy on infant health outcomes in the first year, controlling for age, race/ethnicity, education, insurance coverage, marital status, and cigarette smoking during pregnancy. Women who were younger, minority, unmarried, publicly insured and without a college degree were more likely to report high levels of prenatal stress. High prenatal stress was a significant predictor of maternal reporting of gastrointestinal illness (p

Anecdotally, breastfeeding experiences differ between those who have previously nursed an infant and those who are primiparous. This analysis contrasted breastfeeding outcomes between primiparous women and those with previous experience spanning from maternity stay through 6 months postpartum.A secondary analysis was conducted of data collected in a randomized, controlled trial with mothers and "well" newborns ≥34 weeks of gestation comparing two post-hospital discharge care models. Mothers completed an in-person interview during the postpartum stay and phone surveys at 2 weeks, 2 months, and 6 months where questionnaires related to breastfeeding were completed. All participants intended to breastfeed. Chi-squared and Wilcoxon rank sum tests were used to test for differences between parity groups. Breastfeeding duration by parity group was compared using a Kaplan-Meier plot and a logrank test. A Cox proportional hazards model was used to evaluate the relationship between breastfeeding duration and parity after adjusting for covariates.Among 1,099 mothers available for analysis, 542 (49%) were primiparous. Multiparous mothers had a longer intended breastfeeding duration (median, 9 vs. 6 months; p0.001). Following delivery, primiparous mothers had a longer median time to first breastfeeding attempt (119 vs. 96 minutes; p0.001) and were more likely to have eight or fewer feeding attempts in the first 24 hours (33% vs. 44%; p0.001)). More primiparous women reported early breastfeeding problems (35% vs. 20%; p0.001) and mixed feeding at hospital discharge (39% vs. 23%; p0.001) despite reporting less breastfeeding-associated pain during the first week (p=0.04). Multiparous women were more likely to breastfeed through 6 months (p0.001). In a multivariable Cox model for breastfeeding duration, an interaction existed between intended breastfeeding duration and parity (p=0.006); among those intending to breastfeed for 12 months, multiparous mothers had a significantly lower hazard of stopping breastfeeding (hazard ratio=0.66; p=0.03) than primiparous mothers.Women who have breastfed previously have significantly different breastfeeding experiences than primiparous women. Pre- and postdelivery breastfeeding support should differentially target primiparous women to improve breastfeeding outcomes.

Milk supply concern is the most common reason for breastfeeding discontinuation and maternal anxiety is also associated with reduced breastfeeding duration. Newborn excess weight loss (EWL) could trigger milk supply concern and anxiety and might be amenable to modification. Our objective was to determine the relationship between EWL and the development of milk supply concern and anxiety and the effect of such development on breastfeeding duration. We conducted a cohort analysis using data previously obtained from a randomised controlled trial comparing two post-hospital discharge follow-up strategies. For 1107 well, singleton infants born at ≥34 weeks, we extracted data on all inpatient infant weights. EWL was defined as the loss of ≥10% of birthweight. We surveyed mothers to obtain data on state anxiety and milk supply concern at birth and at 2 weeks. Our final outcome was breastfeeding at 6 months. Seventy (6.3%) infants developed EWL during the birth hospitalisation. At 2 weeks, milk supply concern and positive anxiety screen were more common (42% and 18%, respectively) among mothers whose infants had had EWL than among mothers whose infants had not had EWL (20% and 6%, respectively) (P

BACKGROUND: The majority of newborns are exclusively breastfed during the birth hospitalization, and weight loss is nearly universal for these neonates. The amount of weight lost varies substantially among newborns with higher amounts of weight loss increasing risk for morbidity. No hour-by-hour newborn weight loss nomogram exists to assist in early identification of those on a trajectory for adverse outcomes. METHODS: For 161 471 term, singleton neonates born at ≥36 weeks’ gestation at Northern California Kaiser Permanente hospitals in 2009–2013, data were extracted from the birth hospitalization regarding delivery mode, race/ethnicity, feeding type, and weights from electronic records. Quantile regression was used to create nomograms stratified by delivery mode that estimated percentiles of weight loss as a function of time among exclusively breastfed neonates. Weights measured subsequent to any nonbreastmilk feeding were excluded. RESULTS: Among this sample, 108 907 newborns had weights recorded while exclusively breastfeeding with 83 433 delivered vaginally and 25 474 delivered by cesarean. Differential weight loss by delivery mode was evident 6 hours after delivery and persisted over time. Almost 5% of vaginally delivered newborns and >10% of those delivered by cesarean had lost ≥10% of their birth weight 48 hours after delivery. By 72 hours, >25% of newborns delivered by cesarean had lost ≥10% of their birth weight. CONCLUSIONS: These newborn weight loss nomograms demonstrate percentiles for weight loss by delivery mode for those who are exclusively breastfed. The nomograms can be used for early identification of neonates on a trajectory for greater weight loss and related morbidities.

Background Anthropometric data prove valuable for screening and monitoring various medical conditions. In young infants, however, only weight, length and head circumference are represented in publicly accessible databases. Aim To characterise length and circumferential measures in pre-term and full-term infants up to 90 days post-natal. Subjects and methods In eight US medical centres, trained raters recorded humeral, ulnar, femoral, tibial and fibular lengths along with mid-upper arm, mid-thigh, chest, abdominal and neck circumference. Data were pooled by post-menstrual age into 1-week intervals and population curves created using the lambda, mu and sigma (LMS) method. Goodness-of-fit was assessed by examining de-trended quantile-quantile plots, Q statistics and fitted centiles overlaid on empirical centiles. Results In total, 2097 infants were enrolled in this study with a mean ± SD gestational age and post-natal age of 37.1 ± 3.3 weeks and 27.3 ± 25.3 days, respectively. A re-scale option was used to describe all curves. The resultant models reliably characterised anthropometric measures from 33-52 weeks PMA, with less certainty at the extremes (27-55 weeks). Conclusion The population curves generated under this investigation expand existing reference data on a comprehensive set of anthropometric traits in infants through the first 90 days post-natal.

Although widely used by infants, little is known about the long-term effects of pacifiers. We investigated relationships between pacifier use in infancy and appetite, temperament, feeding, and weight outcomes through age 2 years using data from the Intervention Nurses Start Infants Growing on Healthy Trajectories study.Mother-newborn dyads were randomized to a responsive parenting intervention for obesity prevention or a control group. Infants with data on pacifier use (n = 250) were categorized as using a pacifier beyond early infancy (≥4 months of age) or not. Anthropometrics were measured at 6 months, 1, and 2 years with overweight defined as weight-for-length ≥95th percentile at 1 year and BMI ≥85th percentile at 2 years. Mothers completed questionnaires on temperament, appetite, and feeding.Infants who used a pacifier at 4 months or later (68%) had greater conditional weight gain from birth to 6 months (p = 0.01), weight-for-length z-score at 1 year (p 0.001), and BMI z-score at 2 years (p 0.001) than infants who did not. Infants using a pacifier at ≥4 months were more likely to be overweight at ages 1 year (11.7% vs. 1.3%, p = 0.03) and 2 years (20.1% vs. 7.9%, p = 0.03). Pacifier use was associated with shorter breastfeeding duration and less responsive parent feeding styles, but these variables did not mediate the relationship between pacifiers and weight. Parent-reported temperament and appetite were unrelated to pacifier use.Pacifier use beyond early infancy is associated with accelerated infant growth and toddler overweight, although the reasons for this relationship are unclear.

INTRODUCTION: To prevent errors, healthcare professional and safety organizations recommend using milliliters (mL) alone for oral liquid medication dosing instructions and devices. In 2018, for federal incentives under the Quality Payment Program, one requirement is for Electronic Health Records (EHRs) to automatically use mL alone whenever oral liquid medications are prescribed. Current perceptions and practices of primary care providers (PCPs) regarding dosing units for oral liquid medications were assessed. METHODS: Pediatricians, family practitioners, nurse practitioners, and internists participating in the 2015 DocStyles web-based survey were asked about their perceptions and practices regarding dosing units for oral liquid medications. RESULTS: Three-fifths of PCPs (59.0%) reported that using mL alone is safest for dosing oral liquid medications; however, nearly three-quarters (72.0%) thought that patients/caregivers prefer instructions that include spoon-based units. Within each specialty, fewer PCPs reported they would prescribe using mL alone than reported that using mL alone is safest (P

Objective To determine whether using 10 mL formula after each breastfeeding before copious maternal milk production affects breastfeeding duration, readmission, and intestinal microbiota through 1 month of age. Study design In this randomized controlled trial, we enrolled 164 exclusively breastfeeding newborns, 24-72 hours old, whose weight loss was ≥75th percentile for age, and whose mothers had not yet begun mature milk production. Enrolled newborns were assigned randomly to either supplement breastfeeding with early limited formula (ELF), 10 mL of formula after each breastfeeding stopped at the onset of copious maternal milk production (intervention), or to continue exclusive breastfeeding (control). Outcomes assessed through 1 month included breastfeeding duration, readmission, and intestinal microbiota. Results At 1 week of age, 95.8% of infants receiving ELF and 93.5% of control infants were still breastfeeding (P > .5); readmission occurred for 4 (4.8%) control infants and none of the infants receiving ELF (P = .06). At 1 month of age, 86.5% of infants receiving ELF and 89.7% of control infants were still breastfeeding (P > .5); 54.6% of infants receiving ELF and 65.8% of controls were breastfeeding without formula (P = .18). ELF did not lead to decreased abundance of Lactobacillus or Bifidobacterium and was not associated with expansion of Clostridium. Conclusion In this population of healthy newborns with weight loss ≥75th percentile, ELF did not interfere with breastfeeding at 1 month, breastfeeding without formula at 1 month, or intestinal microbiota. ELF may be an important therapeutic option for newborns with the potential to reduce readmission rates. Trial Registration Clinicaltrials.gov : NCT02313181.

OBJECTIVES: The American Academy of Pediatrics recommends infant-parent room-sharing until age 1. We assessed the association between room-sharing and sleep outcomes. METHODS: The Intervention Nurses Start Infants Growing on Healthy Trajectories study is an obesity prevention trial comparing a responsive parenting intervention with a safety control among primiparous mother-infant dyads. Mothers completed the Brief Infant Sleep Questionnaire at 4, 9, 12, and 30 months. Reported sleep duration and overnight behaviors, adjusted for intervention group, were compared among early independent sleepers (own room RESULTS: At 4 months, reported overnight sleep duration was similar between groups, but compared with room-sharers, early independent sleepers had better sleep consolidation (longest stretch: 46 more minutes, P = .02). At 9 months, early independent sleepers slept 40 more minutes nightly than room-sharers and 26 more minutes than later independent sleepers (P = .008). The longest stretch for early independent sleepers was 100 and 45 minutes more than room-sharers and later independent sleepers, respectively (P = .01). At 30 months, infants sleeping independently by 9 months slept >45 more minutes nightly than those room-sharing at 9 months (P = .004). Room-sharers had 4 times the odds of transitioning to bed-sharing overnight at both 4 and 9 months (P < .01 for both). CONCLUSIONS: Room-sharing at ages 4 and 9 months is associated with less nighttime sleep in both the short and long-term, reduced sleep consolidation, and unsafe sleep practices previously associated with sleep-related death.