Effect of Health Insurance Status and Visitation Restrictions on Virtual Visitation Technology in the Neonatal Intensive Care Unit.

OBJECTIVE: This study aimed to examine the relationship between virtual technology system utilization and insurance status or type of visitation restrictions in a single-center neonatal intensive care unit. STUDY DESIGN: Prospective cohort study with separate analyses performed based on insurance status (public vs. nonpublic) and "in effect" unit visitation restrictions. The three study epochs based on patient visitation restrictions were Epoch 1 (July to October 2019) with standard visitation restrictions, Epoch 2 (November 2019 to February 2020) with respiratory syncytial virus/influenza visitation restrictions, and Epoch 3 (March to June 2020) with coronavirus disease 2019 (COVID-19) visitation restrictions, respectively. RESULTS: Families of 357 infants used web-based cameras through most of the infant's hospitalization (median: 86.05%, Q3: 97.9%) with 165,795 total camera logins, indicating consistent utilization. There was a trend for fewer logins per infant and significantly longer time to consent (p = 0.03) in the Public Insurance group. Unit visitation restrictions impacted the time to consent, the shortest being in Epoch 3 during the COVID-19 pandemic (p = 0.03). CONCLUSION: Virtual visitation technology is well embraced by neonatal instensive care unit families; however, gaps in access and use among subgroups signals a form of social inequality that needs to be explored further. KEY POINTS: · Virtual visitation technology can bridge the distance gap for families of hospitalized infants.. · Utilization of virtual technology is affected by socioeconomic factors and seasonal unit visitation restrictions.. · Factors influencing disparities in access and utilization of virtual technology need to be investigated further..

A Standardized, 3-Tiered, Seizure Burden-Based Protocol for the Treatment of Neonatal Seizures.

OBJECTIVE: To evaluate use of a standardized, 3-tiered, seizure burden-based protocol for treatment of all electroencephalography (EEG)-confirmed seizures in a level IV neonatal intensive care unit (NICU). STUDY DESIGN: All infants admitted to the NICU with EEG-confirmed seizures over a 25-month period were enrolled in the study. We compared short-term outcomes before and after implementation of a standardized, 3-tiered protocol. RESULTS: A total of 107 infants were enrolled in the study. Use of midazolam infusions was reduced by 53.7% (p = 0.02). Midazolam infusion duration increased from 4 to 7.5 days (p = 0.003); however, when excluding 3 outliers, there was no significant difference between groups (-p = 0.67). Duration of EEG monitoring decreased from 5 to 3 days (p = 0.005). Hospital length of stay was unchanged. CONCLUSION: Implementation of a standardized, 3-tiered protocol for treatment of neonatal seizures improved short-term outcomes. Although not measured directly, reductions in EEG duration and midazolam use are promising indicators of overall seizure burden. More research is needed to evaluate impact on long-term neurodevelopmental outcomes.

Financial Incentives for COVID-19 Vaccines Among People Experiencing Homelessness.

INTRODUCTION: Novel strategies are needed to address barriers to COVID-19 vaccination among people experiencing homelessness (PEH), a population that faces increased COVID-19 risk. Although growing evidence suggests that financial incentives for vaccination are acceptable to PEH, their impact on uptake is unknown. This study aimed to assess whether offering $50 gift cards was associated with the uptake of the first doses of COVID-19 vaccine among PEH in Los Angeles County. METHODS: Vaccination clinics began on March 15, 2021; the financial incentive program was implemented from September 26, 2021 to April 30, 2022. Interrupted time-series analysis with quasi-Poisson regression was used to evaluate the level and slope change in the number of weekly first doses administered. Time-varying confounders included the weekly number of clinics and the weekly number of new cases. Demographic characteristics were compared for PEH vaccinated before and after the implementation of the incentive program using chi-square tests. RESULTS: Offering financial incentives was associated with the administration of 2.5 times (95% CI=1.8, 3.1) more first doses than would have been expected without the program. Level (-0.184, 95% CI= -1.166, -0.467) and slope change (0.042, 95% CI=0.031, 0.053) were observed. Individuals who were unsheltered, aged <55 years, and identified as Black or African American accounted for a higher percentage of those vaccinated during the post-intervention period than during the pre-intervention period. CONCLUSIONS: Financial incentives may be an effective tool for increasing vaccine uptake among PEH, but important ethical considerations must be made to avoid coercion of vulnerable populations.

Adverse Childhood Experiences and Health-Related Quality of Life in Adulthood in American Indians and Alaska Natives.

Adverse childhood experiences (ACEs) can result in trauma that persists into adulthood. The goal of this study was to estimate the associations of ACEs with health-related quality of life (HRQOL) metrics in American Indian and Alaska Native (AI/AN) adults in the United States using data from the 2015-2019 Behavioral Risk Factor Surveillance System. Adults (n = 1,389) were asked about current health and ACEs during childhood. ACE score was defined as the total number of ACEs reported. HRQOL outcomes included fair or poor general health, poor general health, poor physical health, poor mental health, and poor physical or mental health. Weighted logistic regression was used to measure the association between ACE score and HRQOL outcomes. A unit increase in ACE score was associated with 14% greater odds of fair or poor general health (OR = 1.14, 95% CI: 1.06, 1.23) and nearly 30% greater odds of poor mental health in the last 30 days (OR = 1.29, 95% CI: 1.20, 1.40). ACEs pose a threat to quality of life in AI/AN adults. These results highlight the need for ACEs prevention in AI/AN communities. Future studies should identify factors associated with resilience to best inform prevention and treatment strategies.

American Indian/Alaska Native Birth and Maternal Health Outcomes in Louisiana: Investigating Regional Disparities.

OBJECTIVES: To report regional maternal and infant health characteristics in the Louisiana American Indian/Alaska Native (AIAN) population. METHODS: This was a cross-sectional descriptive analysis using 2016-2019 Louisiana birth certificate data (N = 242,359; 3205 AIAN births). Prevalence of health characteristics and disparities from population averages were calculated. Health characteristics included low birth weight, preterm birth, very low birth weight, very preterm birth, high birth weight, NICU admission, breastfeeding at discharge, rurality, cesarean section, inadequate prenatal care, and maternal smoking. RESULTS: Low birth weight prevalence ranged from 5.7% in central Louisiana to 20.7% in northeast Louisiana. Most other infant outcomes followed a similar pattern. Disparities from regional averages also varied. AIAN infants had 8% higher risk of LBW than the northeast Louisiana average and 4% lower risk in central Louisiana. Maternal smoking was most prevalent in northern and western Louisiana. Across Louisiana, maternal smoking was as or more prevalent in mothers of AIAN infants compared to regional averages. CONCLUSIONS FOR PRACTICE: There is substantial regional variability in maternal and infant health characteristics in Louisiana AIAN populations, motivating emphasis on locally focused epidemiology to better serve Indigenous communities.

Interdisciplinary Treatment for Survivors of Critical Illness due to COVID-19: Expanding the Post-Intensive Care Recovery Model and Impact on Psychiatric Outcomes.

BACKGROUND: Post-intensive care unit recovery programs for survivors of critical illness related to COVID-19 remain limited, ever-evolving, and under active investigation. Mental health professionals have an emerging role within this multidisciplinary care model. OBJECTIVE: This article explores the design and implementation of an intensive care unit follow-up clinic in New Orleans during the era of COVID-19. Survivors of a critical illness due to COVID-19 were offered multidisciplinary outpatient treatment and systematic psychological screening up to 6 months after the initial clinic visit. METHODS: We implemented a prospective, observational study at a post-intensive care syndrome (PICS) clinic for survivors of a critical illness related to COVID-19 embedded within an academic Veterans Affairs hospital. Our team identified patients at high risk of PICS and offered them a clinic consultation. Patients were provided the following interventions: review of the critical care course, medication reconciliation, primary care, psychopharmacotherapy, psychotherapy, and subspecialty referrals. Patients were followed up at 1- to 3-month intervals. Psychological symptom screening was conducted with Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition, 9-question Patient Health Questionnaire, and 7-item Generalized Anxiety Disorder assessments. RESULTS: Seventy-seven total patients were identified to be at high risk of PICS from March to November 2020, and of this cohort, 44 (57.14%) survived their COVID-19 hospitalizations. Of the surviving 44 patients contacted, 21 patients established care in the PICS clinic and returned for at least 1 follow-up visit. At initial evaluation, 66.7% of patients demonstrated clinically meaningful symptoms of post-traumatic stress disorder. At 3-month follow-up, 9.5% of patients showed significant post-traumatic stress disorder symptoms. Moderate-to-severe symptoms of anxiety were present in 38.1% of patients at initial evaluation and in 4.8% of patients at 3 months. Moderate-to-severe symptoms of depression were present in 33.4% and 4.8% of patients at initial visit and at 3 months, respectively. CONCLUSIONS: A PICS clinic serves as a posthospitalization model of care for COVID-19 intensive care unit survivors. This type of health care infrastructure expands the continuum of care for patients enduring the consequences of a critical illness. We identified a high prevalence of post-traumatic stress, anxiety, and depression, along with other post- intensive care unit complications warranting an intervention. The prevalence of distressing psychological symptoms diminished across all domains by 3 months.

Trends in Postpartum Contraceptive Use in 20 U.S. States and Jurisdictions: The Pregnancy Risk Assessment Monitoring System, 2015-2018.

INTRODUCTION: In the last decade, state and national programs and policies aimed to increase access to postpartum contraception; however, recent data on population-based estimates of postpartum contraception is limited. METHODS: Using Pregnancy Risk Assessment Monitoring System data from 20 sites, we conducted multivariable-adjusted weighted multinomial regression to assess variation in method use by insurance status and geographic setting (urban/rural) among people with a recent live birth in 2018. We analyzed trends in contraceptive method use from 2015 to 2018 overall and within subgroups using weighted multinomial logistic regression. RESULTS: In 2018, those without insurance had lower odds of using permanent methods (adjusted odds ratio [AOR], 0.72; 95% confidence interval [CI], 0.53-0.98), long-acting reversible contraception (LARC) (AOR, 0.67; 95% CI, 0.51-0.89), and short-acting reversible contraception (SARC) (AOR, 0.61; 95% CI, 0.47-0.81) than those with private insurance. There were no significant differences in these method categories between public and private insurance. Rural respondents had greater odds than urban respondents of using all method categories: permanent (AOR, 2.15; 95% CI, 1.67-2.77), LARC (AOR, 1.31; 95% CI, 1.04-1.65), SARC (AOR, 1.42; 95% CI, 1.15-1.76), and less effective methods (AOR, 1.38; 95% CI, 1.11-1.72). From 2015 to 2018, there was an increase in LARC use (odds ratio [OR], 1.03; 95% CI, 1.01-1.05) and use of no method (OR, 1.05; 95% CI, 1.02-1.07) and a decrease in SARC use (OR, 0.97; 95% CI, 0.95-0.99). LARC use increased among those with private insurance (OR, 1.05; 95% CI, 1.02-1.08) and in urban settings (OR, 1.04; 95% CI, 1.02-1.07), but not in other subgroups. CONCLUSIONS: We found that those without insurance had lower odds of using effective contraception and that LARC use increased among those who had private insurance and lived in urban areas. Strategies to increase access to contraception, including increasing insurance coverage and investigating whether effectiveness of existing initiatives varies by geographic setting, may increase postpartum contraceptive use and address these differences.

Impact of a Standardized Nutrition Bundle Including Donor Human Milk on Hospital Outcomes in Very Low Birth-Weight (VLBW) Infants in a Safety-Net Hospital.

BACKGROUND: Standardized protocols have been shown to reduce clinical practice variation and improve patient outcomes. PURPOSE: To measure the impact of a standardized nutrition bundle inclusive of donor human milk (DHM) on hospital outcomes of very low birth-weight (VLBW) infants in a safety-net hospital. METHODS: The study used the Model for Improvement methodology to drive improvement in practice. Outcome measures consisted of necrotizing enterocolitis (NEC), mortality, growth at 36 weeks' postmenstrual age and discharge, as well as volume and type of milk consumption during hospitalization. FINDINGS: NEC rate decreased from 16.67% in the control group to 6.78% in the standardized nutrition bundle group (P = .07). Similarly, there was significant reduction in mortality with the bundled intervention (15.6% in the control group vs 1.6% in the nutrition bundle group; P = .006). Time to first (15 vs 27.5 hours of life; P < .001) and full-volume enteral feeding (8.5 vs 10 days; P = .086) were reduced in the standardized nutrition bundle group compared with the control group. The human milk volume almost doubled with the intervention. IMPLICATIONS FOR PRACTICE: Our standardized nutrition bundle protocol inclusive of DHM resulted in lower NEC rates and reduced mortality. The implementation of the DHM program proved to be cost-effective and saved lives. Our findings may help guide development of a structured approach to nutrition protocols inclusive of DHM that can be adapted by other units located in safety-net hospitals. IMPLICATIONS FOR RESEARCH: Future research on ethnic and racial barriers to access and affordability of DHM is warranted and much needed.

Breastfeeding-supportive hospital practices and breastfeeding maintenance: results from the Louisiana pregnancy risk assessment monitoring system.

OBJECTIVE: Identify practices associated with breastfeeding maintenance, examine breastfeeding-related hospital practices by hospital designation level (Baby Friendly vs. Gift vs. none), and assess racial disparities in hospital practices and breastfeeding maintenance. STUDY DESIGN: The Pregnancy Risk Assessment Monitoring System is a population-based survey of mothers who have recently given birth. Non-Hispanic Black (NHB) and non-Hispanic White (NHW) participants who gave birth from 2016-2019 and initiated breastfeeding were included (n = 2200). Associations between twelve breastfeeding-related hospital and breastfeeding at 2-6 months postpartum were assessed. Baby Friendly hospital designation is based on a set of criteria related to hospital practices that promote breastfeeding. The Gift is a Louisiana program that offers a lower level designation and quality improvement support designed to help hospitals transition to and achieve Baby Friendly designation. RESULT: Breastfeeding in the hospital, infant only receiving breast milk, and breastfeeding within one hour after birth were positively associated and receiving a gift pack with formula was negatively associated with breastfeeding maintenance in both NHW and NHB women. Associations were stronger in NHW compared to NHB mothers. CONCLUSION: We identified several practices significantly associated with breastfeeding maintenance. However, racial disparities indicate a need for population-specific supportive practices.

Examining an In-Home Behavioral Parent Training Protocol Among Parents Who Use Substances Involved Child Welfare: Effectiveness of SafeCare.

Given the detrimental impact of substance use (SU) on both parent and child outcomes including child maltreatment, research and service efforts have focused on incorporating parenting resources into integrated SU treatment programs. While promising, it is imperative to examine and test parenting programs in a variety of settings. This study examined whether SU moderated the relationship between treatment condition and parenting outcomes among parents who participated in SafeCare, and parent ratings of engagement, service satisfaction, and perceived cultural competency of services. Results indicated that SU did not moderate the relationship between treatment condition and abuse potential, but did moderate this relationship for depression and parental distress such that parents with higher levels of SU reported less improvement in depression and parental distress. Results underscore that SU problems may impact the effectiveness of SC on specific risk factors, such as depression and parental distress, potentially indicating unique treatment needs and the need to adapt interventions to ensure treatment success. In addition, this study found that SafeCare was not found to be beneficial for parents with SU problems above and beyond the treatment as usual condition. Finally, results indicated that parents with SU concerns and without SU concerns engaged very similarly in SafeCare.

The impact of the Baby Friendly Hospital Initiative on neonatal hypoglycemia.

OBJECTIVE: To assess Neonatal Intensive Care Unit (NICU) admissions for hypoglycemia after the introduction of the Baby Friendly Hospital Initiative (BFHI), followed by implementation of American Academy of Pediatrics recommended hypoglycemia guidelines. STUDY DESIGN: Retrospective review of NICU admissions for hypoglycemia. Eligible subjects were healthy infants >35 weeks gestation transferred to a NICU for hypoglycemia. Infants admitted with other pathologies were excluded. NICU admissions from 3 different 18-month epochs (1 = pre-BFHI; 2 = post-BFHI; 3 = post-BFHI+hypoglycemia guidelines) were compared. RESULTS: After implementation of BFHI there was a statistically significant increase in admissions for hypoglycemia (Epoch 2 = 1.23% vs Epoch 1 = 0.55%, p < 0.001). Followed by a decrease in admissions after the implementation of hypoglycemia guidelines (Epoch 2 = 1.23% vs Epoch 3 = 0.76%, p = 0.03). CONCLUSION: NICU admissions for hypoglycemia increased with the BFHI. Hypoglycemia guidelines decreased NICU admissions, but not to the pre-BFHI baseline.

Implementing an intensive care unit (ICU) diary program at a large academic medical center: Results from a randomized control trial evaluating psychological morbidity associated with critical illness.

BACKGROUND: Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). ICU diaries are an intervention increasingly under study with potential to mitigate ICU-related psychological morbidity, including ICU-related post-traumatic stress disorder (PTSD), depression and anxiety. As we encounter a growing number of ICU survivors, in particular in the wake of the coronavirus pandemic, clinicians must be equipped to understand the severity and prevalence of significant psychiatric complications of critical illness. METHODS: We compared the efficacy of the ICU diary, written by family and healthcare workers during the patient's intensive care course, versus education alone in reducing acute PTSD symptoms after discharge. Patients with an ICU stay >72 h, who were intubated and mechanically ventilated over 24 h, were recruited and randomized to either receive a diary at bedside with psychoeducation or psychoeducation alone. Intervention patients received their ICU diary within the first week of admission into the intensive care unit. Psychological symptom screening with IES-R, PHQ-8, HADS and GAD-7 was conducted at baseline within 1 week of ICU discharge and at weeks 4, 12, and 24 after ICU discharge. Change from baseline in these scores was assessed using Wilcoxon rank sum tests. RESULTS: From September 26, 2017 to September 25, 2018, our team screened 265 patients from the surgical and medical ICUs at a single large academic urban hospital. 60 patients were enrolled and randomized, of which 35 patients completed post-discharge follow-up, (n = 18) in the diary intervention group and (n = 17) in the education-only control group. The control group had a significantly greater decrease in PTSD, hyperarousal, and depression symptoms at week 4 compared to the intervention group. There were no significant differences in other measures, or at other follow-up intervals. Both study groups exhibited clinically significant PTSD symptoms at all timepoints after ICU discharge. Follow-up phone interviews with patients revealed that while many were interested in getting follow-up for their symptoms, there were many barriers to accessing appropriate therapy and clinical attention. CONCLUSIONS: Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay. However, our study finds an important gap in clinical practice - patients at high risk for PICS are infrequently connected to appropriate follow-up care. Perhaps ICU diaries would prove beneficial if utilized to support the work within a program providing wrap-around services and close psychiatric follow up for PICS patients. This study demonstrates the high prevalence of ICU-related PTSD in our cohort of survivors, the high barrier to accessing care for appropriate treatment of PICS, and the consequence of that barrier-prolonged psychological morbidity. TRIAL REGISTRATION: NCT04305353. GRANT IDENTIFICATION: GH-17-022 (Arnold P. Gold Foundation).

The global epidemiology of hypertension.

Hypertension is the leading cause of cardiovascular disease and premature death worldwide. Owing to the widespread use of antihypertensive medications, global mean blood pressure (BP) has remained constant or has decreased slightly over the past four decades. By contrast, the prevalence of hypertension has increased, especially in low- and middle-income countries (LMICs). Estimates suggest that 31.1% of adults (1.39 billion) worldwide had hypertension in 2010. The prevalence of hypertension among adults was higher in LMICs (31.5%, 1.04 billion people) than in high-income countries (28.5%, 349 million people). Variations in the levels of risk factors for hypertension, such as high sodium intake, low potassium intake, obesity, alcohol consumption, physical inactivity and unhealthy diet, may explain some of the regional heterogeneity in hypertension prevalence. Despite the increasing prevalence, the proportions of hypertension awareness, treatment and BP control are low, particularly in LMICs, and few comprehensive assessments of the economic impact of hypertension exist. Future studies are warranted to test implementation strategies for hypertension prevention and control, especially in low-income populations, and to accurately assess the prevalence and financial burden of hypertension worldwide.

A hybrid 4-item Krousel-Wood Medication Adherence Scale predicts cardiovascular events in older hypertensive adults.

BACKGROUND: There is a need for a brief, open access, self-report medication adherence scale that overcomes challenges of existing adherence tools, is associated with incident cardiovascular disease (CVD), and identifies low 'implementation' adherers to antihypertensive medications to facilitate blood pressure management. METHODS AND RESULTS: Antihypertensive medication adherence was assessed in a cohort of 1532 older hypertensive adults without prior CVD using the self-report 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4), a hybrid tool developed to predict pharmacy refill and which captures four domains of adherence behavior: self-efficacy, physical function, intentional medication-taking, and forgetfulness. The 4-item scale categorized participants as low and high adherers using scores at least 1 and less than 1, respectively. Participants were followed after K-Wood-MAS-4 assessment to identify incident CVD events (stroke, myocardial infarction, congestive heart failure, or CVD death). The prevalence of low adherence was 38.7%. During a median follow-up of 2.8 years (maximum 3.8 years), 136 (8.9%) participants had an incident CVD event; 12.8 and 6.4% in low and high adherers, respectively. The adjusted hazard ratio (aHR) for incident CVD associated with low versus high adherence was 2.29 [95% confidence interval (CI): 1.61, 3.26]. Results were similar when stratified by age [<75 years - aHR 3.53 (95% CI: 1.65, 7.56); ≥75 years - aHR 1.98 (95% CI: 1.32, 2.97)], sex [women - aHR 1.90 (95% CI: 1.16, 3.12); men - aHR 2.80 (95% CI: 1.68, 4.65)], and race [black - aHR 2.22 (95% CI: 0.93, 5.31); white - aHR 2.26 (95% CI: 1.54, 3.34)]. CONCLUSION: Low medication adherence using the 'hybrid' K-Wood-MAS-4 predicts incident CVD in a cohort of older adults with established hypertension.

Cumulative Antiretroviral Exposure Measured in Hair Is Not Associated With Measures of HIV Persistence or Inflammation Among Individuals on Suppressive ART.

Data on the relationship of antiretroviral exposure to measures of human immunodeficiency virus (HIV) persistence are limited. To address this gap, multiple viral, immunologic, and pharmacologic measures were analyzed from individuals with sustained virologic suppression on therapy (median 7 years) in the AIDS Clinical Trials Group A5321 cohort. Among 110 participants on tenofovir-(TFV)-disoproxil-fumarate (TDF)/emtricitabine (FTC)-containing regimens, we found no significant correlation between hair concentrations of individual antiretrovirals (ARVs) in the regimen and measures of HIV persistence (plasma HIV-1 RNA by single copy assay, cell-associated-DNA, cell-associated RNA) or soluble markers of inflammation. These findings suggest that higher systemic ARV exposure may not impact HIV persistence or inflammation.

ACTG A5353: A Pilot Study of Dolutegravir Plus Lamivudine for Initial Treatment of Human Immunodeficiency Virus-1 (HIV-1)-infected Participants With HIV-1 RNA <500000 Copies/mL.

Background: Limited data exist on initial human immunodeficiency virus type 1 (HIV-1) treatment with dolutegravir plus lamivudine. Methods: A5353 is a phase 2, single-arm, pilot study of once-daily dolutegravir (50 mg) plus lamivudine (300 mg) in treatment-naive participants with HIV-1 RNA ≥1000 and <500000 copies/mL. Exclusion criteria included active hepatitis B or major protease, reverse transcriptase, or integrase resistance. The primary efficacy measure was the proportion with HIV-1 RNA <50 copies/mL (FDA [US Food and Drug Administration] Snapshot) at week 24. Virologic failure (VF) was confirmed HIV-1 RNA >400 copies/mL at week 16/20 or >200 copies/mL at or after week 24. Dolutegravir levels and drug resistance testing were performed at VF. Results: One hundred and twenty participants (87% male, median age 30 years, 37 (31%) HIV-1 RNA >100000 copies/mL) initiated study treatment. Median entry HIV-1 RNA and CD4 count were 4.61 log10 copies/mL and 387 cells/mm3. Virologic efficacy at week 24 was 108/120 (90%, confidence interval [83%, 95%]), with comparable results in the >100000 copies/mL and ≤100000 copies/mL strata, that is, 89% (75%, 97%) and 90% (82%, 96%), respectively. Three participants with VF, had undetected plasma dolutegravir at ≥1 time points; the M184V and R263R/K mutations developed in 1 participant. Two participants experienced grade 3 possible/probable treatment-related adverse events; none discontinued treatment due to adverse events. Conclusions: Dolutegravir plus lamivudine demonstrated efficacy in individuals with pretreatment HIV-1 RNA up to 500000 copies/mL in this pilot trial, but a participant developed resistance mutations. Clinical Trials Registration: NCT02582684.

Very low birth weight infant care: adherence to a new nutrition protocol improves growth outcomes and reduces infectious risk.

BACKGROUND: Very low birth weight (VLBW) infants are at risk for postnatal growth restriction due to inadequate nutrient delivery and concomitant illness. Integrated clinical pathways or protocols can improve growth outcomes by decreasing practice variability. METHODS: A comprehensive nutrition bundle comprising standardized recommendations for initiating, advancing, and fortifying enteral feedings, and timely discontinuation of central lines was implemented in July 2012. Eligible were infants with a birth weight of <1500 g and <34 weeks gestation who were born over a 1-year period pre- and post-intervention, respectively. The primary aim was to determine if the intervention improved anthropometric parameter delta z scores at 36 weeks PMA. Secondary aims included time to first and full enteral feedings, central line-days, and rates of necrotizing enterocolitis (NEC) and sepsis/sepsis-like episodes. RESULTS: A total of 299 infants were included, of which 156 received the proposed intervention (Nutrition bundle group), and 143 received non-standardized nutrition practices (Conventional group). Median delta z scores for length (-1.2 versus -1.71; p=0.01) and head circumference (-0.73 versus -1.21; p=0.03) but not weight at 36 weeks PMA (-1.42 versus -1.58; p=0.74) were significantly higher in the Nutrition bundle group as compared to the Conventional group. Fewer infants in the intervention group had severe growth restriction. Time to first feed, full feeds, and central line duration were significantly shorter in the intervention period. The incidence of NEC and sepsis/sepsis-like episodes decreased with the intervention. CONCLUSIONS: A strategy using a comprehensive nutrition bundle improved linear and head circumference growth, reduced postnatal growth restriction, and decreased comorbidities in VLBW infants.

Pharmacokinetics and tissue penetration of cefoxitin in obesity: implications for risk of surgical site infection.

BACKGROUND: Obesity is a significant risk factor for surgical site infections (SSIs), for poorly understood reasons. SSIs are a major cause of morbidity, prolonged hospitalization, and increased health care cost. Drug disposition in general is frequently altered in the obese. Preoperative antibiotic administration, achieving adequate tissue concentrations at the time of incision, is an essential strategy to prevent SSIs. Nonetheless, there is little information regarding antibiotic concentrations in obese surgical patients. This investigation tested the hypothesis that the prophylactic antibiotic cefoxitin may have delayed and/or diminished tissue penetration in the obese. METHODS: Plasma and tissue concentrations of cefoxitin were determined in obese patients undergoing abdominal and pelvic surgery (body mass index 43 ± 10 kg/m(2), n = 14, 2 g cefoxitin) and in normal-weight patients and healthy volunteers (body mass index 20 ± 2 kg/m(2), n = 13, 1 g cefoxitin). Tissue concentrations were measured using a microdialysis probe in the subcutaneous layer of the abdomen, and in adipose tissue excised at the time of incision and wound closure. RESULTS: Plasma concentrations and area under the concentration-time curve (AUC) were approximately 2-fold higher in the obese patients because of the 2-fold-higher dose. Dose-normalized concentrations were higher, although AUCs were not significantly different. Measured and dose-normalized subcutaneous cefoxitin concentrations and AUCs in the obese patients were significantly lower than in the normal-weight subjects. There was an inverse relationship between cefoxitin tissue penetration (AUC(tissue)/AUC(plasma) ratio) and body mass index. Tissue penetration was substantially lower in the obese patients (0.08 ± 0.07 vs 0.37 ± 0.26, P < 0.05). Adipose tissue cefoxitin concentrations in obese patients were only 7.8 ± 7.3 and 2.7 ± 1.4 µg/g, respectively, at incision and closure, below the minimum inhibitory concentration of 8 and 16 µg/mL, respectively, for aerobic and anaerobic microorganisms. CONCLUSION: Obese surgical patients have impaired tissue penetration of the prophylactic antibiotic cefoxitin, and inadequate tissue concentrations despite increased clinical dose (2 g). Inadequate tissue antibiotic concentrations may be a factor in the increased risk of SSIs in obese surgical patients. Additional studies are needed to define doses achieving adequate tissue concentrations.