A comparison of FreeStyle Libre 2 to self-monitoring of blood glucose in children with type 1 diabetes and sub-optimal glycaemic control: a 12-week randomised controlled trial protocol.

PURPOSE: Frequent glucose monitoring is necessary for optimal glycaemic control. Second-generation intermittently scanned glucose monitoring (isCGM) systems inform users of out-of-target glucose levels and may reduce monitoring burden. We aim to compare FreeStyle Libre 2 (Abbott Diabetes Care, Witney, U.K.) to self-monitoring of blood glucose in children with type 1 diabetes and sub-optimal glycaemic control. METHODS: This open-label randomised controlled trial will enrol 100 children (4-13 years inclusive, diagnosis of type 1 diabetes ≥ 6 months, HbA1c 58-110 mmol/mol [7.5-12.2%]), from 5 New Zealand diabetes centres. Following 2 weeks of blinded sensor wear, children will be randomised 1:1 to control or intervention arms. The intervention (duration 12 weeks) includes second-generation isCGM (FreeStyle Libre 2) and education on using interstitial glucose data to manage diabetes. The control group will continue self-monitoring blood glucose. The primary outcome is the difference in glycaemic control (measured as HbA1c) between groups at 12 weeks. Pre-specified secondary outcomes include change in glucose monitoring frequency, glycaemic control metrics and psychosocial outcomes at 12 weeks as well as isCGM acceptability. DISCUSSION: This research will investigate the effectiveness of the second-generation isCGM to promote recommended glycaemic control. The results of this trial may have important implications for including this new technology in the management of children with type 1 diabetes. TRIAL REGISTRATION: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 19 February 2020 (ACTRN12620000190909p) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1237-0090).

Nutritional Implications of Baby-Led Weaning and Baby Food Pouches as Novel Methods of Infant Feeding: Protocol for an Observational Study.

BACKGROUND: The complementary feeding period is a time of unparalleled dietary change for every human, during which the diet changes from one that is 100% milk to one that resembles the usual diet of the wider family in less than a year. Despite this major dietary shift, we know relatively little about food and nutrient intake in infants worldwide and virtually nothing about the impact of baby food "pouches" and "baby-led weaning" (BLW), which are infant feeding approaches that are becoming increasingly popular. Pouches are squeezable containers with a plastic spout that have great appeal for parents, as evidenced by their extraordinary market share worldwide. BLW is an alternative approach to introducing solids that promotes infant self-feeding of whole foods rather than being fed purées, and is popular and widely advocated on social media. The nutritional and health impacts of these novel methods of infant feeding have not yet been determined. OBJECTIVE: The aim of the First Foods New Zealand study is to determine the iron status, growth, food and nutrient intakes, breast milk intake, eating and feeding behaviors, dental health, oral motor skills, and choking risk of New Zealand infants in general and those who are using pouches or BLW compared with those who are not. METHODS: Dietary intake (two 24-hour recalls supplemented with food photographs), iron status (hemoglobin, plasma ferritin, and soluble transferrin receptor), weight status (BMI), food pouch use and extent of BLW (questionnaire), breast milk intake (deuterium oxide "dose-to-mother" technique), eating and feeding behaviors (questionnaires and video recording of an evening meal), dental health (photographs of upper and lower teeth for counting of caries and developmental defects of enamel), oral motor skills (questionnaires), and choking risk (questionnaire) will be assessed in 625 infants aged 7.0 to 9.9 months. Propensity score matching will be used to address bias caused by differences in demographics between groups so that the results more closely represent a potential causal effect. RESULTS: This observational study has full ethical approval from the Health and Disability Ethics Committees New Zealand (19/STH/151) and was funded in May 2019 by the Health Research Council (HRC) of New Zealand (grant 19/172). Data collection commenced in July 2020, and the first results are expected to be submitted for publication in 2022. CONCLUSIONS: This large study will provide much needed data on the implications for nutritional intake and health with the use of baby food pouches and BLW in infancy. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620000459921; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379436. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/29048.

Coastal clustering of HEV; Cornwall, UK.

BACKGROUND AND AIMS: Autochthonous hepatitis E virus (HEV) infection is a porcine zoonosis and increasingly recognized in developed countries. In most cases the route of infection is uncertain. A previous study showed that HEV was associated geographically with pig farms and coastal areas. AIM: The aim of the present research was to study the geographical, environmental and social factors in autochthonous HEV infection. METHODS: Cases of HEV genotype 3 infection and controls were identified from 2047 consecutive patients attending a rapid-access hepatology clinic. For each case/control the following were recorded: distance from home to nearest pig farm, distance from home to coast, rainfall levels during the 8 weeks before presentation, and socioeconomic status. RESULTS: A total of 36 acute hepatitis E cases, 170 age/sex-matched controls and 53 hepatitis controls were identified. The geographical spread of hepatitis E cases was not even when compared with both control groups. Cases were more likely to live within 2000 m of the coast (odds ratio=2.32, 95% confidence interval=1.08-5.19, P=0.03). There was no regional difference in the incidence of cases and controls between west and central Cornwall. There was no difference between cases and controls in terms of distance from the nearest pig farm, socioeconomic status or rainfall during the 8 weeks before disease presentation. CONCLUSION: Cases of HEV infection in Cornwall are associated with coastal residence. The reason for this observation is uncertain, but might be related to recreational exposure to beach areas exposed to HEV-contaminated 'run-off' from pig farms. This hypothesis merits further study.

Baby-Led Introduction to SolidS (BLISS) study: a randomised controlled trial of a baby-led approach to complementary feeding.

BACKGROUND: In 2002, the World Health Organization recommended that the age for starting complementary feeding should be changed from 4 to 6 months of age to 6 months. Although this change in age has generated substantial debate, surprisingly little attention has been paid to whether advice on how to introduce complementary foods should also be changed. It has been proposed that by 6 months of age most infants will have developed sufficient motor skills to be able to feed themselves rather than needing to be spoon-fed by an adult. This has the potential to predispose infants to better growth by fostering better energy self-regulation, however no randomised controlled trials have been conducted to determine the benefits and risks of such a "baby-led" approach to complementary feeding. This is of particular interest given the widespread use of "Baby-Led Weaning" by parents internationally. METHODS/DESIGN: The Baby-Led Introduction to SolidS (BLISS) study aims to assess the efficacy and acceptability of a modified version of Baby-Led Weaning that has been altered to address potential concerns with iron status, choking and growth faltering. The BLISS study will recruit 200 families from Dunedin, New Zealand, who book into the region's only maternity hospital. Parents will be randomised into an intervention (BLISS) or control group for a 12-month intervention with further follow-up at 24 months of age. Both groups will receive the standard Well Child care provided to all parents in New Zealand. The intervention group will receive additional parent contacts (n = 8) for support and education on BLISS from before birth to 12 months of age. Outcomes of interest include body mass index at 12 months of age (primary outcome), energy self-regulation, iron and zinc intake and status, diet quality, choking, growth faltering and acceptability to parents. DISCUSSION: This study is expected to provide insight into the feasibility of a baby-led approach to complementary feeding and the extent to which this method of feeding affects infant body weight, diet quality and iron and zinc status. Results of this study will provide important information for health care professionals, parents and health policy makers. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612001133820 .

Neonatal extravasation injury: prevention and management in Australia and New Zealand-a survey of current practice.

BACKGROUND: Extravasation injury remains an important cause of iatrogenic injury in neonatal intensive care. This study aims to describe the current approach to extravasation injury (EI) prevention and management in Neonatal Intensive Care Units (NICUs) in Australia and New Zealand. METHODS: A literature review regarding extravasation injury in the newborn was carried out to inform questionnaire design. An internet-based survey was then conducted with the clinical directors of the 27 tertiary NICUs in Australia and New Zealand. RESULTS: The survey received a 96% response rate. Approximately two thirds of Australian and New Zealand NICUs have written protocols for prevention and management of extravasation injury. Considerable practice variation was seen for both prevention and treatment of EI. 92% of units had experienced cases of significant EI. CONCLUSIONS: Australian and New Zealand tertiary neonatal units clearly recognise EI as an important cause of iatrogenic morbidity and mortality. Significant variation still exists among units with regards to guidelines for both prevention and management of EI. We recommend that neonatal staff should remain vigilant, ensuring that guidelines for the prevention and treatment of EI are available, and rigorously followed.

Premedication for neonatal intubation in Australia and New Zealand: a survey of current practice.

AIM: This study aims to describe the current approach to intubation premedication in neonatal intensive care units (NICUs) in Australia and New Zealand. METHODS: A literature review regarding intubation premedication in the newborn was carried out to inform questionnaire design. A web-based survey of 28 NICUs and two neonatal emergency transport services was conducted and supplemented by telephone contact to ensure completion. RESULTS: All the tertiary NICUs and neonatal emergency transport services in Australia and New Zealand use premedication for elective intubation of neonates. Eighty per cent of units have a written policy. There were 28 of 30 units (93%) that use muscle relaxants, mostly suxamethonium. The choice of sedative medication is varied. CONCLUSIONS: Australian and New Zealand neonatal units have a high use of intubation premedication including muscle relaxants, but vary considerably in their choice of sedative medication.

Geographical inequalities in health in New Zealand, 1980-200: the gap widens.

OBJECTIVE: To monitor geographical inequalities in health in New Zealand during the period 1980 to 2001, a time of rapid social and economic change in society. METHODS: Age-standardised mortality rates were calculated using mortality records aggregated to a consistent set of geographical areas (the 2001 District Health Boards) for the periods 1980-82, 1985-87, 1990-92, 1995-97 and 1999-2001. In addition, the Relative Index of Inequality (RII) was calculated for each period to provide a robust measure of mortality rates over time. RESULTS: Although overall mortality rates have declined through the period 1980 to 2001, the reduction has not been consistent for all areas of New Zealand. Indeed for a small number of DHBs, mortality rates have increased slightly. There has been an increase in the geographical inequalities in health as measured by the RII between each time period except for between 1986 and 1991, where there was a small reduction. CONCLUSIONS: At the start of the 21st century, geographical inequalities in health in New Zealand have reached very high levels and continue to increase. The excess mortality for the worst areas in New Zealand increased from 15% in 1981 to 25% in 2000. If policy makers are committed to reducing health inequalities then more redistributive economic policies are required.

Using geographical information systems and spatial microsimulation for the analysis of health inequalities.

The paper presents a spatial microsimulation approach to the analysis of health inequalities. A dynamic spatial microsimulation model of Britain, under development at the Universities of Leeds and Sheffield, uses data from the censuses of 1971, 1981 and 1991 and the British Household Panel Survey to simulate urban and regional populations in Britain. Geographical information systems and spatial microsimulation are used for the analysis of health inequalities in British regions in a 30 year simulation. The interdependencies between socio-economic characteristics and health variables such as limiting long-term illness are discussed. One of the innovative features of the model is the estimation of variables such as household income at the small area level, which can then be used to classify individuals. The health situation of different simulated individuals in different areas is investigated and the role of socio-economic characteristics in determining health is evaluated.