Independent clinic-based evaluation of dual POCTs for screening for HIV and syphilis in men who have sex with men in Italy, Malta, Peru, and the United Kingdom.

INTRODUCTION: Globally, the incidence of HIV and syphilis can be reduced by the use of validated point of care tests (POCTs). As part of the WHO PRoSPeRo Network, we aimed to evaluate the performance, acceptability, and operational characteristics of two dual HIV/syphilis POCTs (Bioline HIV/Syphilis Duo (Abbott) and DPP® HIV-Syphilis assay (Chembio) for the screening of HIV and syphilis amongst men who have sex with men (MSM). METHOD AND ANALYSES: A cross sectional study of 2,577 MSM in Italy, Malta, Peru, and the United Kingdom (UK) presenting to seven clinic sites, were enrolled. Finger prick blood was collected to perform POCTs and results compared with standard laboratory investigations on venepuncture blood. Acceptability and operational characteristics were assessed using questionnaires. Diagnostic meta-analysis was used to combine data from the evaluation sites. RESULTS: Based on laboratory tests, 23.46% (n = 598/2549) of participants were confirmed HIV positive, and 35.88% of participants (n = 901/2511) were positive on treponemal reference testing. Of all participants showing evidence of antibodies to Treponema pallidum, 50.56% (n = 455/900) were Rapid Plasma Reagin (RPR) test reactive. Of HIV positive individuals, 60.62% (n = 354/584) had evidence of antibodies to T. pallidum, and of these 60.45% (n = 214/354) exhibited reactive RPR tests indicating probable (co)infection. For Bioline POCT, pooled sensitivities and specificities for HIV were 98.95% and 99.89% respectively, and for syphilis were 73.79% and 99.57%. For Chembio pooled sensitivities and specificities for HIV were 98.66% and 99.55%, and for syphilis were 78.60% and 99.48%. Both tests can detect greater than 90% of probable active syphilis cases, as defined by reactive RPR and treponemal test results. These dual POCTs were preferred by 74.77% (n = 1,926) of participants, due to their convenience, and the operational characteristics made them acceptable to health care providers (HCPs). CONCLUSIONS: Both the Bioline and the Chembio dual POCT for syphilis and HIV had acceptable performance, acceptability and operational characteristics amongst MSM in the PRoSPeRo network. These dual POCTs could serve as a strategic, more cost effective, patient and healthcare provider (HCP) friendly alternative to conventional testing; in clinical and other field settings, especially those in resource-limited settings.

Parental supporter during pediatric resuscitation: Qualitative exploration of caregivers' and healthcare professionals' experiences and perceptions.

BACKGROUND: Child resuscitation is a critical and stressful time for family caregivers and healthcare professionals. The aim of this study was to explore caregivers' and healthcare professionals' experiences and perceptions of a parental supporter during pediatric cardiopulmonary resuscitation to provide guidance to healthcare professionals on supporting parents and other family caregivers during resuscitation. METHODS: This study used an exploratory descriptive qualitative approach. The setting was two large referral pediatric governmental hospitals. Participants were 17 caregivers who had experienced their child's resuscitation, and 13 healthcare professionals who served on resuscitation teams in emergency rooms or intensive care wards. Semi-structured, in-depth interviews were conducted and data were analyzed using thematic analysis. COREQ guidelines were followed. RESULTS: Participants shared their experiences and perceptions of a parental supporter during pediatric resuscitation in three themes: 1) Requirement for the presence of a parental supporter, 2) Expectations of the parental supporter, and 3) Characteristics of the parental supporter. CONCLUSIONS: Study findings highlight the need for a parental supporter during pediatric resuscitation; however, there is no defined parental supporter role in current guiding policies due to limited research on this role. More research on the parental supporter role is needed so effective policies and protocols can be developed to enhance family-centered care practices in pediatric emergency and acute care settings.

Kidney Considerations in Pediatric Obesity.

PURPOSE OF REVIEW: Chronic kidney disease (CKD) is a common condition and a major cause of morbidity and mortality in adults, but children and adolescents are also at risk for early kidney injury and development of CKD. Obesity contributes both directly and indirectly to the development of CKD. The purpose of this review is to describe obesity-related kidney disease (ORKD) and diabetic kidney disease (DKD) and their impact in the pediatric population. RECENT FINDINGS: Although obesity-related CKD in childhood and adolescence is uncommon, nascent kidney damage may magnify the lifetime risk of CKD. Glomerular hyperfiltration is an early phenotype of both ORKD and DKD and typically manifests prior to albuminuria and progressive decline in GFR. Novel treatments for obesity and type 2 diabetes exerting protective effects on the kidneys are being investigated for use in the pediatric population. It is important to understand the impact of obesity on the kidneys more fully in the pediatric population to help detect injury earlier and intervene prior to the onset of irreversible progression of disease and to guide future research in this area.

The role of spatial structure in at-risk metapopulation recoveries.

Metapopulations are often managed as a single contiguous population despite the spatial structure underlying their local and regional dynamics. Disturbances from human activities can also be spatially structured with mortality impacts concentrated to just a few local populations among the aggregate. Scale transitions between local and regional processes can generate emergent properties whereby the whole system can fail to recover as quickly as expected for an equivalent single population. Here, we draw on theory and empirical case studies to ask: what is the consequence of spatially structured ecological and disturbance processes on metapopulation recoveries? We suggest that exploring this question could help address knowledge gaps for managing metapopulations including: Why do some metapopulations recover quickly while others remain collapsed? And, what risks are unaccounted for when metapopulations are managed at aggregate scales? First, we used model simulations to examine how scale transitions among ecological and disturbance conditions interact to generate emergent metapopulation recovery outcomes. In general, we found that the spatial structure of disturbance was a strong determinant of recovery outcomes. Specifically, disturbances that unevenly impacted local populations consistently generated the slowest recoveries and highest conservation risks. Ecological conditions that dampened metapopulation recoveries included low dispersal, variable local demography, sparsely connected habitat networks, and spatially and temporally correlated stochastic processes. Second, we illustrate the unexpected challenges of managing metapopulations by examining the recoveries of three USA federally listed endangered species: Florida Everglade snail kites, California and Alaska sea otters, and Snake River Chinook salmon. Overall, our results show the pivotal role of spatial structure in metapopulation recoveries whereby the interplay between local and regional processes shapes the resilience of the whole system. With this understanding, we provide guidelines for resource managers tasked with conserving and managing metapopulations and identify opportunities for research to support the application of metapopulation theory to real-world challenges.

"It's changed my life not to have the continual worry of being warm" - health and wellbeing impacts of a local fuel poverty programme: a mixed-methods evaluation.

BACKGROUND: Living in a cold home and being fuel poor can contribute to adverse physical and mental health. Energy efficiency interventions are considered the simplest ways of tackling fuel poverty and preventing associated negative health, wellbeing, and socio-economic consequences. The overall aim of the current study was to provide a greater understanding of the impact of a locally administered programme, which funded the installation of major heating/insulation measures in areas of high fuel poverty, on the health and wellbeing of beneficiaries of the programme. METHODS: A mixed-methods approach to explore the health and wellbeing impacts of a fuel poverty programme in East Sussex that took place between October 2016 and March 2018. Beneficiaries completed the Warwick-Edinburgh Mental Wellbeing Scale before and after any heating/insulation work had been completed in their home. Beneficiaries were also asked to retrospectively rate their health pre- and post-installation. Interviews with 23 beneficiaries of the programme were conducted to explore in-depth the impact of the programme on people's health and wellbeing and the wider social determinants of health. RESULTS: A major heating/insulation measure was installed in 149 homes. The majority of measures installed were boilers (57.7%) and new central heating systems (32.2%). Self-rated health and wellbeing were significantly higher post-installation. Interviewees described clear examples of the positive impacts on physical health and wellbeing such as fewer chest infections, reduced pain, feeling less anxious and depressed, and generally feeling happier and more relaxed. Interviews also highlighted broader areas of impact such as reduced social isolation and increased use of domestic space. Many of the beneficiaries also reported a reduction in their energy bills since their new heating systems had been installed. CONCLUSIONS: The findings from the evaluation suggest that the installation of major heating or insulation measures such as new boilers have substantial benefits for the health and wellbeing of beneficiaries. The findings also suggest that the programme had a positive impact on wider determinants of health including reduction in stress and isolation that are likely to be part of the pathways between fuel poverty interventions and mental and physical health outcomes.

Glycemic Control in Relation to Technology Use in a Single-Center Cohort of Children with Type 1 Diabetes.

Background: Technology for patients with type 1 diabetes (T1D), including continuous glucose monitoring (CGM), insulin pumps, and hybrid closed-loop (HCL) systems, is improving, being used more commonly in the pediatric population, and impacts glycemic control. Materials and Methods: We evaluated the use of these technologies and their impact on glycemic control among patients with T1D who were seen at the Barbara Davis Center (n = 4003) between January 2018 and December 2020, <22 years old, with diabetes duration >3 months. Data were analyzed by age group and technology-use group defined as multiple daily injection with blood glucose meter (MDI/BGM), pump with BGM (pump/BGM), MDI with CGM (MDI/CGM), and pump with CGM (pump/CGM). Glycemic control was compared using analysis of covariance (ANCOVA) and controlling for diabetes duration, race, and insurance. Results: Among 4003 patients, 20% used MDI/BGM (mean hemoglobin A1c [HbA1c] = 10.0%); 14.4% used pump/BGM (mean HbA1c = 10.0%); 15.4% used MDI/CGM (mean HbA1c = 8.6%); and 49.8% used pump/CGM (mean HbA1c = 8.1%). Compared with MDI/BGM patients, MDI/CGM and pump/CGM users had a lower HbA1c and were more likely to reach an HbA1c <7.0% (all P < 0.0001). Among pump/CGM users, 35% used HCL technology (mean HbA1c = 7.6%) and had a lower HbA1c and were more likely to reach an HbA1c <7% than non-HCL users (P < 0.001). Conclusions: CGM use was associated with a lower HbA1c in both MDI and pump users. Pump use was only associated with a lower HbA1c if used with CGM. HCL was associated with the lowest HbA1c. Spanish language and minority race/ethnicity were associated with lower rates of pump and CGM use, highlighting the need to reduce disparities.

Vitamin K and ECMO for neonatal hypoxic respiratory failure.

INTRODUCTION: The objectives of this retrospective cohort study were to examine the effect of vitamin K administration on hemorrhagic and thrombotic complications, blood product utilization, and outcomes in neonatal extracorporeal membrane oxygenation (ECMO). METHODS: In the pilot study, complications, blood product use, and outcome data for neonates who received (n = 21) or did not receive (n = 18) a single dose of vitamin K (5 mg) immediately after initiation of ECMO for respiratory failure between 2006 and 2010 were compared. In the validation cohort, complications and outcomes were compared for 74 consecutive neonates supported with ECMO for respiratory failure who received (n = 45) or did not receive (n = 29) additional vitamin K once daily for prothrombin time (PT) ⩾14 seconds during ECMO from 2014 to 2019. RESULTS: In the pilot study, vitamin K at ECMO initiation was associated with fewer thrombotic complications and similar hemorrhagic complications. The volume of fresh frozen plasma was higher in neonates who received vitamin K, but total blood product and other component volume did not differ between groups. ECMO run time, survival off ECMO, survival to discharge, and length of stay did not differ between cohorts. In the validation cohort, neonates who received additional vitamin K during ECMO had longer ECMO run time and length of stay, but no difference in mortality was observed. Further, thrombotic and hemorrhagic complications as well as blood product exposure were similar between cohorts. CONCLUSIONS: These data suggest that routine vitamin K administration may have limited or no benefit during neonatal ECMO.

Validity and reliability of the Iranian preterm birth experiences and satisfaction scale: A methodological and cross-sectional study.

Background: Women's experience and satisfaction with childbirth care are increasingly being addressed by health care providers, managers, and policymakers. Due to need for a validated special scale for assessing satisfaction of women with preterm birth, we aimed to translate and adapt the first specific tool, Preterm Birth Experiences and Satisfaction Scale (P-BESS), into Persian language and evaluate its psychometric properties. Methods: A methodological and cross-sectional study was conducted in two tertiary levels of maternal hospitals in Tabriz. The Iranian version of the scale was developed from the original English version using forward-backward translation. After confirmation of its face and content validity, the scale was completed by 201 women who had given birth prematurely. Results: Exploratory factor analysis revealed three factors (staff professionalism and empathy, confidence in Staff, information and explanations) with eigenvalues greater than 1, explaining a total variance of 55.4%. Confirmatory factory analysis showed that the 17-item, three factor model fitted the data well: the root mean square error of approximation 0.060. There were moderate correlations between the total and sub-scales of Iranian P-BESS and overall satisfaction (r = 0.45 to 0.66), as well as need for improvement (r = -0.46 to -0.61), which confirm convergent validity. Internal consistency and test-retest reliability of the scale and its sub-scales were satisfactory (α = 0.852 to 0.922, intraclass correlation coefficient; 0.83 to 0.92). Conclusion: The Iranian version of P-BESS is a valid and reliable scale which can be used by policy makers, managers, health care providers and researchers.

Parent-child conversations associated with alcohol-related risk behaviours in young people (13-17 years) in the UK: a cross-sectional study.

OBJECTIVE: To investigate different types of parent-child conversations associated with young people's (13-17 years) alcohol-related risk behaviours. DESIGN: Secondary analysis of the 2016 Drinkaware Monitor Survey. This survey employed a cross-sectional design and collected data using self-completion questionnaires. SETTING: UK-wide. PARTICIPANTS: 561 parent-child pairs were included in the analysis. The nationally representative quota sample was weighted by reference to the UK population. METHODOLOGY: Data were analysed using purposeful selection modelling (adjusted OR (AOR), 95% CIs). RISK BEHAVIOURS: 'Whether have ever drank' and 'whether vomited as a result of alcohol'. RESULTS: 50% (277/553) of young people reported drinking a whole alcoholic drink, and 22% (60/277) of these experienced vomiting as a result. After adjusting for age and gender, the likelihood of ever having drank alcohol was significantly increased among the following young people: those whose parents believed they knew a little about how much they drink (AOR 1.80, 95% CI 1.04 to 3.13) or that some/most/all friends drink (AOR 3.82, 95% CI 2.40 to 6.08); those given gentle reminders about taking care when drinking alcohol (AOR 1.82, 95% CI 1.15 to 2.88), practical advice (AOR 2.09, 95% CI 1.20 to 3.64) or designated time, led by the parent, to instil care around alcohol through a formal sit-down (AOR 1.79, 95% CI 1.07 to 2.99). The likelihood was reduced for parents aged 40-49 years (AOR 0.52, 95% CI 0.31 to 0.89) and conversations providing information (AOR 0.53, 95% CI 0.29 to 0.98). Vomiting was significantly associated with some/most/all friends drinking alcohol (AOR 3.65, 95% CI 1.08 to 12.30), parent's beliefs about child's frequency of drinking alcohol (AOR 1.26, 95% CI 1.02 to 1.54), parental harmful/dependency drinking (AOR 3.75, 95% CI 1.13 to 12.50) and having a formal sit-down conversation (AOR 2.15, 95% CI 0.99 to 4.66). CONCLUSIONS: We found evidence of mostly negative associations between young people's risk behaviours and different types of parent-child conversations. Conversations providing information were linked to a reduced tendency to have ever drunk alcohol. All other types of conversations were negatively associated with risk behaviours. Psychological reactance and conversation quality possibly explain these findings.

Proportionality at birth and left ventricular hypertrophy in healthy adolescents.

BACKGROUND: Perinatal growth has important implications for cardiac development. Low birth weight is associated with cardiovascular (CV) events and mortality, and animal studies have shown that fetal growth restriction is associated with cardiac remodeling in the perinatal period leading to a permanent loss of cardiomyocyte endowment and compensatory hypertrophy. AIMS: To determine associations of birthweight (BW) and multiple proportionality indexes (body mass index (BMI); weight/length2 and Ponderal index (PI); weight/length3) at birth on one hand, with left ventricular (LV) structure and function during adolescence. SUBJECTS: 379 healthy adolescents aged 14-18 years in Augusta, Georgia. OUTCOME MEASURES: LV structure and function parameters, including intraventricular septal thickness in diastole (IVSd), LV internal dimension in diastole (LVIDd), LV internal diameter in systole (LVIDs), LV posterior wall thickness in diastole (LVPWd), relative wall thickness (RWT), midwall fractional shortening (MFS), and ejection fraction, were assessed by echocardiography. RESULTS: When associations of birthweight, birth BMI, and birth PI with LV structure and function parameters were separately evaluated with linear regression adjusting for age, sex, race, Tanner stage, socioeconomic status, and physical activity, significant positive associations of BW with LVIDd (P = 0.004), birth BMI with LV mass index (P = 0.01), and birth PI with IVSd (P = 0.02), LVPWd (P = 0.03), and LV mass index (P = 0.002) were identified. When LV structure and function parameters were compared across PI tertiles, a significant U-shaped trend for LV mass index (Pquadratic = 0.04) was identified. CONCLUSIONS: Our adolescent data suggest that proportionality at birth may identify associations between perinatal growth and cardiac remodeling independent of birthweight alone.

Women's experiences of participating in a randomised trial comparing alternative policies for timing of cord clamping at very preterm birth: a questionnaire study.

BACKGROUND: The Cord Pilot Trial compared two alternative policies for cord-clamping at very preterm birth at eight UK tertiary maternity units: clamping after at least 2 min and immediate neonatal care with cord intact, or clamping within 20 s and neonatal care after clamping. This paper reports views and experiences of the women who participated in the trial (261 randomised), based on data from two self-completed questionnaires. METHODS: Women were given or posted the first questionnaire between 4 and 8 weeks after birth, and posted a second similar questionnaire at 1 year. Both questionnaires included three questions about experiences of participating in the trial: (1) If time suddenly went backwards and you had to do it all over again, would you agree to participate in the Cord Pilot Trial?; (2) Please tell us if there was anything about the Cord Pilot Trial that you think could have been done better; and (3) Please tell us if there was anything about the Cord Pilot Trial, or your experiences of joining the trial, that you think were particularly good. RESULTS: One hundred and eighty-six women completed the first questionnaire and 133 completed the second. At both time points, 90% responded 'probably' or 'definitely' to participating in the trial again. More women randomised to deferred clamping responded 'definitely yes' than those allocated immediate clamping (78% versus 67% first questionnaire). Women were positive about the level of information and explanations, the friendly and caring staff, and the benefits for their baby and others as a result of participating in the trial. Suggestions for how the trial could be done better included being approached earlier, better staff communication about the trial, more information overall, and better timing of follow-up. CONCLUSIONS: Women were largely positive about participating in the trial. Nevertheless, they had suggestions for how the study could have been improved. These suggestions have implications for the design of future trials. TRIAL REGISTRATION: ISRCTN21456601 . Registered on 28 February 2013.

Cord pilot trial, comparing alternative policies for timing of cord clamping before 32 weeks gestation: follow-up for women up to one year.

BACKGROUND: The Cord Pilot Trial compared two alternative policies for cord clamping at very preterm birth at eight UK maternity units: clamping after at least 2 min and immediate neonatal care (if needed) with cord intact, or clamping within 20 s and neonatal care after clamping. This paper reports follow-up of the women by two self-completed questionnaires up to one year after the birth. METHODS: Women were given or posted the first questionnaire between four and eight weeks after birth, usually before their baby was discharged, and were posted a second similar questionnaire at one year. The questionnaire included the Hospital Anxiety and Depression Scale; the Preterm Birth Experience and Satisfaction Scale (P-BESS) and questions about their baby's feeding. RESULTS: Of 261 women randomised (132 clamping ≥2 min, 129 clamping ≤20 s), six were excluded as birth was after 35+ 6 weeks (2, 4 in each group respectively). Six were not sent either questionnaire. The first questionnaire was given/sent to 244 and returned by 186 (76%) (79, 74%). The second, at one year, was sent to 242 and returned by 133 (55%) (66, 43%). On the first questionnaire, 89 (49%) had a score suggestive of an anxiety disorder, and 55 (30%) had a score suggestive of depression. Satisfaction with care at birth was high: median total P-BESS score 77 [interquartile range 68 to 84] (scale 17 to 85). There was no clear difference in anxiety, depression, or satisfaction with care between the two allocated groups. The median number of weeks after birth women breastfed/expressed was 16 (95% confidence interval (CI) 13 to 20, n = 119) for those allocated clamping ≥2 min and 12 (95% CI 11 to 16, n = 103) for those allocated clamping ≤20 s. CONCLUSIONS: The response rate was higher for the earlier questionnaire than at one year. A high proportion of women reported symptoms of anxiety or depression, however there were no clear differences between the allocated groups. Most women reported that they had breastfed or expressed milk and those allocated deferred cord clamping reported continuing this for slightly longer. TRIAL REGISTRATION: ISRCTN 21456601, registered 28th February 2013, http://www.isrctn.com/ISRCTN21456601.

The lifelong impact of fetal growth restriction on cardiac development.

BACKGROUND: Maternal nutrient restriction (MNR) is a widespread cause of fetal growth restriction (FGR), an independent predictor of heart disease and cardiovascular mortality. Our objective was to examine the developmental and long-term impact of MNR-induced FGR on cardiac structure in a model that closely mimics human development. METHODS: A reduction in total caloric intake spanning pregestation through to lactation in guinea pig sows was used to induce FGR. Proliferation, differentiation, and apoptosis of cardiomyocytes were assessed in late-gestation fetal, neonatal, and adult guinea pig hearts. Proteomic analysis and pathway enrichment were performed on fetal hearts. RESULTS: Cardiomyocyte proliferation and the number of mononucleated cells were enhanced in the MNR-FGR fetal and neonatal heart, suggesting a delay in cardiomyocyte differentiation. In fetal hearts of MNR-FGR animals, apoptosis was markedly elevated and the total number of cardiomyocytes reduced, the latter remaining so throughout neonatal and into adult life. A reduction in total cardiomyocyte number in adult MNR-FGR hearts was accompanied by exaggerated hypertrophy and a disorganized architecture. Pathway analysis identified genes related to cell proliferation, differentiation, and survival. CONCLUSIONS: FGR influences cardiomyocyte development during critical windows of development, leading to a permanent deficiency in cardiomyocyte number and compensatory hypertrophy in a rodent model that recapitulates human development.

Understanding conversations about alcohol between parents and their 15-17 year olds: a qualitative study.

BACKGROUND: There is an increasing awareness that parents can play an important role in shaping their children's attitudes towards alcohol and use of alcohol. However, there has been little research exploring the conversations parents have with their children about alcohol. The present study aims to address this gap by exploring conversations between parents and their 15-17 year old children. METHODS: Using a cross-sectional qualitative design, recruitment took place over two phases to allow a purposive maximum variation sample of parents and young people. Sixty-four participants (n = 48 parents; n = 16 young people aged 15-17 years) took part in semi-structured interviews. The sample was diverse and included participants from throughout the United Kingdom. Thematic analysis was used to analyse the data separately for all parents and 16 matched parent-child pairs. RESULTS: The parents' findings were summarised within the following thematic areas: 1) style of conversation; 2) triggers to conversations; 3) topics conveyed during conversations; and 4) supervision of child's alcohol consumption. Most parents were comfortable talking to their children about alcohol. It was considered that open and honest conversations helped demystify alcohol for young people. Most conversations that parents had with their children were brief and informal and a wide range of triggers to these conversations were reported. There was some indication that as children got older conversations became more frequent and more focused on safety. Overall, the matched parent-child interviews were very consistent regarding levels of child drinking, conversation starters, and topics discussed. However, in some cases parents underestimated their child's need and desire for further conversations about alcohol. CONCLUSIONS: Most parents felt comfortable having conversations with their older children about alcohol. However, parents also wanted more support with having these conversations, particularly about how to start a conversation and what to talk about. This study provides several recommendations to help parents have an open conversation about alcohol with their children. For example, brief, informal chats seem to be the most appropriate way of speaking to children about alcohol compared to a more formal, "sit-down" style of conversation.

Women's views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study.

BACKGROUND: The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. In addition to standard written consent, an oral assent pathway was developed for use when birth was imminent. The aim of this study was to explore women's views and experiences of two alternative consent pathways to participate in the Cord Pilot Trial. METHODS: We conducted a qualitative study using semi-structured interviews. A total of 179 participants in the Cord Pilot Trial were sent a postal invitation to take part in interviews. Women who agreed were interviewed in person or by telephone to explore their experiences of two consent pathways for a preterm intrapartum trial. Data were analysed using inductive systematic thematic analysis. RESULTS: Twenty-three women who gave either written consent (n = 18) or oral assent followed by written consent (n = 5) to participate in the trial were interviewed. Five themes were identified: (1) understanding of the implications of randomisation, (2) importance of staff offering participation, (3) information about the trial and time to consider participation, (4) trial secondary in women's minds and (5) reasons for agreeing to take part in the trial. Experiences were similar for the two consent pathways. Women recruited by the oral assent pathway reported being given less information about the trial but felt it was sufficient to make a decision regarding participation. There were gaps in women's understanding of the trial and intervention, regardless of the consent pathway. CONCLUSIONS: Overall, women were positive about their experiences of being invited to participate in the trial. The oral assent pathway seems an acceptable option for women if the intervention is low-risk and time is limited. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN21456601 . Registered on 28 February 2013.

Comparison of transfusion thresholds during neonatal extracorporeal membrane oxygenation.

BACKGROUND: The objective of this study was to assess complications and patient outcomes associated with a lower reflexive red blood cell (RBC) transfusion threshold for neonates undergoing extracorporeal membrane oxygenation (ECMO) for hypoxic respiratory failure. STUDY DESIGN AND METHODS: A retrospective cohort study was conducted at a single tertiary neonatal intensive care unit of neonates undergoing ECMO support for refractory hypoxic respiratory failure for more than 24 hours between December 2009 and December 2014. Seventy-two neonates received ECMO support for hypoxic respiratory failure for longer than 24 hours during the study period. Patient cohorts were determined based on transfusion threshold of hematocrit (Hct) level of less than 40% (December 2009-October 2012) and Hct level of less than 35% (November 2012-December 2014). RESULTS: Patients who had a lower threshold for transfusion (Hct < 35) had a lower mean Hct (38.3% vs. 41.4%, p < 0.0001) and received less total RBC transfusion volume (10.4 mL/kg/day vs. 13.3 mL/kg/day, p = 0.002) while undergoing ECMO support. Survival off ECMO, survival to discharge, and complication rates were similar between the cohorts. CONCLUSIONS: A lower Hct threshold of 35% is associated with a reduction in RBC transfusion volume and does not appear to alter complication rates or patient outcomes for neonates receiving ECMO support for respiratory failure.

Clinicians' views and experiences of offering two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study.

BACKGROUND: The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. Preterm birth can be rapid and unexpected, allowing little time for the usual consent process. Therefore, in addition to the usual procedure for written consent, a two-stage pathway for consent for use when birth was imminent was developed. The aims of this study were to explore clinicians' views and experiences of offering two consent pathways for recruitment to a randomised trial of timing of cord clamping at very preterm birth. METHODS: This was a qualitative study using semi-structured interviews. Clinicians from eight hospitals in the UK who had been involved in offering consent to the Cord Pilot Trial were invited to take part in an interview. Clinicians were interviewed in person or by telephone. Interviews were analysed using inductive systematic thematic analysis. RESULTS: Seventeen clinicians who had either offered usual written consent only (n = 6) or both the two-stage pathway (with oral assent before the birth and written consent after the birth) and usual written consent (n = 11) were interviewed. Six themes were identified: (1) team approach to offering participation; (2) consent form as a record; (3) consent and participation as a continual process; (4) different consent pathways for different trials; (5) balance between time, information, and understanding; and (6) validity of consent. Overall, clinicians were supportive of the two-stage consent pathway. Some clinicians felt that in time-critical situations oral assent presented an advantage over the usual written consent as they provided information on a "need to know" basis. However, there was some concern about how much information should be given for oral assent, and how this is understood by women when birth is imminent. CONCLUSIONS: The two-stage pathway for consent developed for use in the Cord Pilot Trial when birth was imminent was acceptable to clinicians for comparable low-risk studies, although some concerns were raised about the practicalities of obtaining oral assent. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN21456601 . Registered on 28 February 2013.

Neurodevelopmental Outcomes at 2 and 3.5 Years for Very Preterm Babies Enrolled in a Randomized Trial of Milking the Umbilical Cord versus Delayed Cord Clamping.

BACKGROUND: Guidelines published by the International Liaison Committee for Resuscitation and by the World Health Organization recommend delaying cord clamping at birth as part of routine care for infants. OBJECTIVE: To study the use of milking of the cord 4 times as an alternative to enhance the redistribution of placental blood into the baby. METHODS: This is a prospective cohort study of neurodevelopmental assessment by the Bayley III method of very preterm infants who had participated in a trial of delayed cord clamping versus cord milking at birth that was conducted in a neonatal tertiary care hospital. The primary outcomes were differences in cognitive, motor and language development at 2 and 3.5 years. Two-tailed analyses were performed with the x03C7;2 test, Fisher's exact test, t test, Mann-Whitney U test and ANCOVA. RESULTS: Out of the 58 infants enrolled in the original study, 39 infants (67%) were assessed at 2 years and 29 (50%) at 3.5 years of age. Neurodevelopmental outcomes at 2 and 3.5 years did not significantly differ between the two groups for the three Bayley III composite scores. At 3.5 years there was a trend towards higher scores for girls in the language composite scores (girls: mean = 121.6, SD = 15.22; boys: mean = 101.07, SD = 19.84) and on the motor scale (girls: mean = 124.60, SD = 18.15; boys: mean = 97.86, SD = 17.23). CONCLUSIONS: In this small number of participants followed up at 2 and 3.5 years of age, milking of the cord 4 times did not have any long-term adverse effect on neurodevelopmental outcome, suggesting that cord milking could be used as an alternative to delayed cord clamping.

Providing immediate neonatal care and resuscitation at birth beside the mother: clinicians' views, a qualitative study.

OBJECTIVES: The aims of this study were to assess clinicians' views and experiences of providing immediate neonatal care at birth beside the mother, and of using a mobile trolley designed to facilitate this bedside care. DESIGN: Qualitative interview study with semistructured interviews. RESULTS: The results were analysed using thematic analysis. SETTING: A large UK maternity unit. PARTICIPANTS: Clinicians (n=20) from a range of disciplines who were present when the trolley was used to provide neonatal care at birth at the bedside. Five clinicians provided/observed advanced resuscitation by the bedside. RESULTS: Five themes were identified: (1) Parents' involvement, which included 'Contact and involvement', 'Positive emotions for parents' and 'Staff communication'; (2) Reservations about neonatal care at birth beside the mother, which included 'Impact on clinicians' and 'Impact on parents'; (3) Practical challenges in providing neonatal care at the bedside, which included 'Cord length' and 'Caesarean section'; (4) Comparison of the trolley with usual resuscitation equipment and (5) Training and integration of bedside care into clinical routine, which included 'Teething problems' and 'Training'. CONCLUSIONS: Overall, most clinicians were positive about providing immediate neonatal care at the maternal bedside, particularly in terms of the clinicians' perceptions of the parents' experience. Clinicians also perceived that their close proximity to parents improved communication. However, there was some concern about performing more intensive interventions in front of parents. Providing immediate neonatal care and resuscitation at the bedside requires staff training and support.