Biomarkers of exposure and potential harm in exclusive users of electronic cigarettes and current, former, and never smokers.

Electronic cigarette (EC) aerosol emissions generally contain fewer and lower concentrations of harmful and potentially harmful constituents, compared with cigarette smoke. Further studies are needed to establish whether decreased emissions translate to reduced health risks for EC users. In a cross-sectional study, biomarkers of exposure (BoE) to certain tobacco smoke toxicants and biomarkers of potential harm (BoPH), associated with biological processes linked to the potential development of smoking-related diseases and oxidative stress, were assessed in solus Vuse ECs users and current, former, and never smokers.

Assessment of biomarkers of exposure and potential harm, and physiological and subjective health measures in exclusive users of nicotine pouches and current, former and never smokers.

Oral nicotine pouches (NPs) are smokeless, tobacco-free products that have a potential role in tobacco harm reduction strategies. In a cross-sectional study in Sweden/Denmark, several recognised biomarkers of potential harm (BoPHs) linked to smoking-related diseases/their initiating biological processes, and biomarkers of exposure (BoEs) to tobacco/tobacco smoke toxicants were compared among exclusive adult users of Velo NPs and current/former/never smokers. Over 24 h, participants used their usual product (Velo NP or cigarette) as normal, and BoEs/BoPHs were assessed via blood/24-h urine/exhaled breath/physiological assessments.

Biomarkers of Exposure and Potential Harm in Exclusive Users of Nicotine Pouches and Current, Former, and Never Smokers: Protocol for a Cross-sectional Clinical Study.

Background: Tobacco harm reduction (THR) aims to reduce the health burden of cigarettes by encouraging smokers to switch to using alternative tobacco or nicotine products. Nicotine pouches (NPs) are smokeless, tobacco-free, oral products that may be beneficial as part of a THR strategy.

Objective: This 2-center, cross-sectional confinement study conducted in Denmark and Sweden aimed to determine whether biomarkers of exposure (BoEs) to tobacco toxicants and biomarkers of potential harm (BoPHs) in exclusive users of NPs show favorable differences compared with current smokers.

A randomised study to assess the nicotine pharmacokinetics of an oral nicotine pouch and two nicotine replacement therapy products.

Nicotine replacement therapies (NRTs) are intended for short-term use to help cigarette smokers to quit. Some smokers find NRTs ineffective or seek a more satisfactory source of nicotine. Tobacco-free oral nicotine pouch (NP) products have emerged as a potential reduced risk product compared with cigarettes and other tobacco products.

A Randomised Study to Investigate the Nicotine Pharmacokinetics of Oral Nicotine Pouches and a Combustible Cigarette.

Background And Objectives: Nicotine pouches (NPs) are a relatively new type of oral smokeless tobacco-free nicotine product. Currently, few data are available on the nicotine pharmacokinetics or subjective effects of NP use. The objective of this study was to determine and compare the pharmacokinetics of nicotine absorption into the blood from different NP variants and a combustible cigarette.

Chemical characterization of tobacco-free "modern" oral nicotine pouches and their position on the toxicant and risk continuums.

As compared with cigarette smoking, use of Swedish snus is associated with significantly fewer health risks. Nicotine pouches (NPs), a new form of oral nicotine product, are smokeless and tobacco-free, comprising a nicotine-containing cellulose matrix inside a fiber pouch. NPs are similar in appearance/use to snus, but without tobacco, have the potential to further reduce tobacco-related harm.

Energy Density of New Food Products Targeted to Children.

High dietary energy density (ED) is linked to childhood obesity and poor diet quality. The Australian Health Star Rating (HSR) system aims to assist consumers in making healthful food choices. This cross-sectional study used 2014-2018 data from the Mintel Global New Products Database to describe the ED of new food products targeted to children (5-12 years) released after the introduction of HSR and examine relationships between ED and HSR.

Prospective qualification of early cerebral biomarkers in a randomised trial of treatment with xenon combined with moderate hypothermia after birth asphyxia.

Background: The TOBY-Xe proof of concept randomised trial found no effect of xenon combined with hypothermia after birth asphyxia on the lactate to N-acetyl aspartate ratio (Lac/NAA) in the thalamus and fractional anisotropy (FA) in white matter tracts measured within 15 days of birth. To confirm that these biomarkers are qualified to predict long-term outcome after neural rescue therapy we assessed surviving participants at 2-3 years of age.

Methods: Of the 92 infants in TOBY-Xe, one was omitted from the study, 69 survived and we assessed 62 participants, 32 in the hypothermia and xenon and 30 in the hypothermia only groups.

Hypothermia for perinatal asphyxia: trial-based resource use and costs at 6-7 years.

Objective: To assess the impact of hypothermic neural rescue for perinatal asphyxia at birth on healthcare costs of survivors aged 6-7 years, and to quantify the relationship between costs and overall disability levels.

Design: 6-7 years follow-up of surviving children from the Total Body Hypothermia for Neonatal Encephalopathy (TOBY) trial.

Setting: Community study including a single parental questionnaire to collect information on children's healthcare resource use.

Patterns of Change in Metabolic Capabilities of Sediment Microbial Communities in River and Lake Ecosystems.

Information on the biodegradation potential of lake and river microbial communities is essential for watershed management. The water draining into the lake ecosystems often carries a significant amount of suspended sediments, which are transported by rivers and streams from the local drainage basin. The organic carbon processing in the sediments is executed by heterotrophic microbial communities, whose activities may vary spatially and temporally.

Hypothermia for perinatal asphyxia: trial-based quality of life at 6-7 years.

Objective: To assess the impact of hypothermic neural rescue at birth on health-related quality of life (HRQL) in middle childhood.

Design: Six-year to 7-year follow-up of surviving children from the Total Body Hypothermia for Neonatal Encephalopathy (TOBY) Trial.

Setting: Community study including a single parental questionnaire to collect information on children's HRQL.

Punctate White Matter Lesions Associated With Altered Brain Development And Adverse Motor Outcome In Preterm Infants.

Preterm infants who develop neurodevelopmental impairment do not always have recognized abnormalities on cerebral ultrasound, a modality routinely used to assess prognosis. In a high proportion of infants, MRI detects punctate white matter lesions that are not seen on ultrasonography. To determine the relation of punctate lesions to brain development and early neurodevelopmental outcome we used multimodal brain MRI to study a large cohort of preterm infants.

Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluation.

Background: We tested the hypothesis that routine MRI would improve the care and well-being of preterm infants and their families.

Design: Parallel-group randomised trial (1.1 allocation; intention-to-treat) with nested diagnostic and cost evaluations (EudraCT 2009-011602-42).

A novel hybrid tobacco product that delivers a tobacco flavour note with vapour aerosol (Part 2): In vitro biological assessment and comparison with different tobacco-heating products.

This study assessed the toxicological and biological responses of aerosols from a novel hybrid tobacco product. Toxicological responses from the hybrid tobacco product were compared to those from a commercially available Tobacco Heating Product (c-THP), a prototype THP (p-THP) and a 3R4F reference cigarette, using in vitro test methods which were outlined as part of a framework to substantiate the risk reduction potential of novel tobacco and nicotine products. Exposure matrices used included total particulate matter (TPM), whole aerosol (WA), and aqueous aerosol extracts (AqE) obtained after machine-puffing the test products under the Health Canada Intense smoking regime.

Electronic cigarette aerosol induces significantly less cytotoxicity than tobacco smoke.

Electronic cigarettes (E-cigarettes) are a potential means of addressing the harm to public health caused by tobacco smoking by offering smokers a less harmful means of receiving nicotine. As e-cigarettes are a relatively new phenomenon, there are limited scientific data on the longer-term health effects of their use. This study describes a robust in vitro method for assessing the cytotoxic response of e-cigarette aerosols that can be effectively compared with conventional cigarette smoke.

Evaluation of an air-liquid interface cell culture model for studies on the inflammatory and cytotoxic responses to tobacco smoke aerosols.

In vitro toxicological studies for tobacco product assessment have traditionally been undertaken using the particulate phase of tobacco smoke. However, this does not truly reflect exposure conditions that occur in smokers. Thus in vitro cell culture systems are required in which cells are exposed to tobacco whole smoke (WS) at the air-liquid interface (ALI).

Specialization and integration of functional thalamocortical connectivity in the human infant.

Connections between the thalamus and cortex develop rapidly before birth, and aberrant cerebral maturation during this period may underlie a number of neurodevelopmental disorders. To define functional thalamocortical connectivity at the normal time of birth, we used functional MRI (fMRI) to measure blood oxygen level-dependent (BOLD) signals in 66 infants, 47 of whom were at high risk of neurocognitive impairment because of birth before 33 wk of gestation and 19 of whom were term infants. We segmented the thalamus based on correlation with functionally defined cortical components using independent component analysis (ICA) and seed-based correlations.

Early predictors of outcome in infants treated with hypothermia for hypoxic-ischaemic encephalopathy.

Hypoxic-ischaemic encephalopathy (HIE) is a leading cause of acquired neonatal brain injury. Assessment of the severity of cerebral injury and likely neurological outcome in infants with HIE is important for determining management and prognosis, for counselling parents, and for selection for neuroprotective trials. The condition of the infant at birth, the severity of HIE, neurophysiological tests, including amplitude-integrated electroencephalography (aEEG), biochemical markers, and neuroimaging have been used to assess prognosis and predict long-term outcome.

Clinical applications of cerebral function monitoring in neonates.

The cerebral function monitor is a device for trend monitoring of changes in the amplitude of the electroencephalogram, typically recorded from one or two pairs of electrodes. Initially developed and introduced to monitor cerebral activity in encephalopathic adult patients or during anaesthesia, it is now most widely used in newborns to assess the severity of encephalopathy and for determining prognosis. The duration and severity of abnormalities of the amplitude-integrated electroencephalogram tracing is highly predictive of subsequent neurologic outcome following neonatal hypoxic-ischemic encephalopathy, including in newborns receiving neuroprotective treatment with prolonged moderate hypothermia.

Improving infant outcome with a 10 min Apgar of 0.

Objective: Asystole at birth and extending through 10 min is rare, with current international recommendations stating it may be appropriate to consider discontinuation of resuscitation in this clinical scenario. These recommendations are based on small case series of both term and preterm infants, where death or abnormal outcome was nearly universal. Study objective was to determine recent outcome of infants with an Apgar score of 0 at 10 min despite cardiopulmonary resuscitation, treated with therapeutic hypothermia or standard treatment, in randomised cooling studies.

Effects of hypothermia for perinatal asphyxia on childhood outcomes.

Background: In the Total Body Hypothermia for Neonatal Encephalopathy Trial (TOBY), newborns with asphyxial encephalopathy who received hypothermic therapy had improved neurologic outcomes at 18 months of age, but it is uncertain whether such therapy results in longer-term neurocognitive benefits.

Methods: We randomly assigned 325 newborns with asphyxial encephalopathy who were born at a gestational age of 36 weeks or more to receive standard care alone (control) or standard care with hypothermia to a rectal temperature of 33 to 34°C for 72 hours within 6 hours after birth. We evaluated the neurocognitive function of these children at 6 to 7 years of age.

Neonatal ECMO study of temperature (NEST): a randomized controlled trial.

Background: Despite evidence to support the use of extracorporeal membrane oxygenation (ECMO) in defined groups of newborn infants, rates of impairment among survivors remain high. Therapeutic hypothermia has been shown to provide neuroprotection in mature infants exposed to perinatal asphyxia. We hypothesized that therapeutic hypothermia during ECMO would reduce the proportion of infants with brain injury, and thus later impairment.

Predictive value of the amplitude integrated EEG in infants with hypoxic ischaemic encephalopathy: data from a randomised trial of therapeutic hypothermia.

The amplitude integrated EEG (aEEG) is reputed to be one of the best predictors of neurological outcome following hypoxic ischaemic encephalopathy in term newborns and was used to select infants into trials of neuroprotection with hypothermia, but its predictive value and the effect of moderate hypothermia on the aEEG have not previously been examined in a randomised study. The positive predictive value (PPV) of the aEEG recorded within 6 h of birth for death or disability at 18 months of age was determined in 314 infants born after 35 weeks gestation who were randomised to receive standard care with or without cooling for 72 h. The aEEG was classified according to voltage and by pattern.