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Journal articleRyan L, Ploetz FB, van den Hoogen A, et al., 2022,
Neonates and COVID-19: state of the art Neonatal Sepsis series
, Pediatric Research, Vol: 91, Pages: 432-439, ISSN: 0031-3998The SARS-CoV-2 pandemic has had a significant impact worldwide, particularly in middle- and low-income countries. While this impact has been well-recognized in certain age groups, the effects, both direct and indirect, on the neonatal population remain largely unknown. There are placental changes associated, though the contributions to maternal and fetal illness have not been fully determined. The rate of premature delivery has increased and SARS-CoV-2 infection is proportionately higher in premature neonates, which appears to be related to premature delivery for maternal reasons rather than an increase in spontaneous preterm labor. There is much room for expansion, including long-term data on outcomes for affected babies. Though uncommon, there has been evidence of adverse events in neonates, including Multisystem Inflammatory Syndrome in Children, associated with COVID-19 (MIS-C). There are recommendations for reduction of viral transmission to neonates, though more research is required to determine the role of passive immunization of the fetus via maternal vaccination. There is now considerable evidence suggesting that the severe visitation restrictions implemented early in the pandemic have negatively impacted the care of the neonate and the experiences of both parents and healthcare professionals alike. Ongoing collaboration is required to determine the full impact, and guidelines for future management.
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Journal articleMc Cord K, Imran M, Rice DB, et al., 2022,
Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results
, Journal of Clinical Epidemiology, Vol: 141, Pages: 175-186, ISSN: 0895-4356Objective: Registries are important data sources for randomised controlled trials (RCTs), butreporting of how they are used may be inadequate. The objective was to describe the currentadequacy of reporting of RCTs using registries.Study Design and Setting: We used a database of trials using registries from a scopingreview supporting the development of the 2021 CONSORT extension for Trials ConductedUsing Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reportingcompleteness of 13 CONSORT-ROUTINE items was assessed.Results: We assessed reports of 47 RCTs that used a registry, published between 2011 and2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half ofreports (2 in at least 80%). The 7 other items were related to routinely collected data sourceeligibility (32% adequate), data linkage (8% adequate), validation and completeness of dataused for outcome assessment (8% adequate), validation and completeness of data used forparticipant recruitment (0% adequate), participant flow (9% adequate), registry funding (6%adequate) and interpretation of results in consideration of registry use (25% adequate).Conclusion: Reporting of trials using registries was often poor, particularly details on datalinkage and quality. Better reporting is needed for appropriate interpretation of the results ofthese trials.Keywords: registries, CONSORT, CONSORT-ROUTINE, randomised controlled trials,reporting guideline, routinely collected dataRunning Title: Completeness and Transparency of Reporting of RCTs using Registries
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Journal articleShipley L, Mistry A, Sharkey D, 2022,
Outcomes of neonatal hypoxic-ischaemic encephalopathy in centres with and without active therapeutic hypothermia: a nationwide propensity score-matched analysis.
, Arch Dis Child Fetal Neonatal Ed, Vol: 107, Pages: 6-12OBJECTIVE: Therapeutic hypothermia (TH) for neonatal hypoxic-ischaemic encephalopathy (HIE), delivered mainly in tertiary cooling centres (CCs), reduces mortality and neurodisability. It is unknown if birth in a non-cooling centre (non-CC), without active TH, impacts short-term outcomes. DESIGN: Retrospective cohort study using National Neonatal Research Database and propensity score-matching. SETTING: UK neonatal units. PATIENTS: Infants ≥36 weeks gestational age with moderate or severe HIE admitted 2011-2016. INTERVENTIONS: Birth in non-CC compared with CC. MAIN OUTCOME MEASURES: Primary outcome was survival to discharge without recorded seizures. Secondary outcomes were recorded seizures, mortality and temperature on arrival at CCs following transfer. RESULTS: 5059 infants were included with 2364 (46.7%) born in non-CCs. Birth in a CC was associated with improved survival without seizures (35.1% vs 31.8%; OR 1.15, 95% CI 1.02 to 1.31; p=0.02), fewer seizures (60.7% vs 64.6%; OR 0.84, 95% CI 0.75 to 0.95, p=0.007) and similar mortality (15.8% vs 14.4%; OR 1.11, 95% CI 0.93 to 1.31, p=0.20) compared with birth in a non-CC. Matched infants from level 2 centres only had similar results, and birth in CCs was associated with greater seizure-free survival compared with non-CCs. Following transfer from a non-CC to a CC (n=2027), 1362 (67.1%) infants arrived with a recorded optimal therapeutic temperature but only 259 (12.7%) of these arrived within 6 hours of birth. CONCLUSIONS: Almost half of UK infants with HIE were born in a non-CC, which was associated with suboptimal hypothermic treatment and reduced seizure-free survival. Provision of active TH in non-CC hospitals prior to upward transfer warrants consideration.
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Journal articleMitchell E, Oddie SJ, Dorling J, et al., 2021,
Implementing two-stage consent pathway in neonatal trials
, Archives of Disease in Childhood: Fetal and Neonatal Edition, ISSN: 1359-2998Perinatal trials sometimes require rapid recruitment processes to facilitate inclusion of participants when interventions are time-critical. A two-stage consent pathway has been used in some trials and is supported by national guidance. This pathway includes seeking oral assent for participation during the time-critical period followed by informed written consent later. This approach is being used in the fluids exclusively enteral from day one (FEED1) trial where participants need to be randomised within 3 hours of birth. There is some apprehension about approaching parents for participation via the oral assent pathway. The main reasons for this are consistent with previous research: lack of a written record, lack of standardised information and unfamiliarity with the process. Here, we describe how the pathway has been implemented in the FEED1 trial and the steps the trial team have taken to support sites. We provide recommendations for future trials to consider if they are considering implementing a similar pathway. Trial registration number: ISRCTN89654042.
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Journal articleStefani G, Skopec M, Battersby C, et al., 2021,
Why is Kangaroo Mother Care not yet scaled in the UK? A systematic review and realist synthesis of a frugal innovation for newborn care
, BMJ Innovations, Vol: 8, Pages: 9-20, ISSN: 2055-642XObjective: Kangaroo Mother Care (KMC) is a frugal innovation improving newborn health at a reduced cost compared with incubator use. KMC is widely recommended; however, in the UK, poor evidence exists on KMC, and its implementation remains inconsistent.Design: This Systematic Review and Realist Synthesis explores the barriers and facilitators in the implementation of KMC in the UK.Data source: OVID databases, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus and Google Scholar were searched.Eligibility criteria: Studies were UK based, in maternity/neonatal units, for full-term/preterm children. First screening included studies on (1) KMC, Kangaroo Care (KC) or skin-to-skin contact (SSC) or (2) Baby Friendly Initiative, Small Wonders Change Program or family-centred care if in relation to KMC/KC/SSC. Full texts were reviewed for evidence regarding KMC/KC/SSC implementation.Results: The paucity of KMC research in the UK did not permit a realist review. However, expanded review of available published studies on KC and SSC, used as a proxy to understand KMC implementation, demonstrated that the main barriers are the lack of training, knowledge, confidence and clear guidelines.Conclusion: The lack of KMC implementation research in the UK stands in contrast to the already well-proven benefits of KMC for stable babies in low-income contexts and highlights the need for further research, especially in sick and small newborn population. Implementation of, and research into, KC/SSC is inconsistent and of low quality. Improvements are needed to enhance staff training and parental support, and to develop guidelines to properly implement KC/SSC. It should be used as an opportunity to emphasise the focus on KMC as a potential cost-effective alternative to reduce the need for incubator use in the UK.
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Journal articleAbbas-Hanif A, Modi N, Smith SK, et al., 2021,
Covid-19 treatments and vaccines must be evaluated in pregnancy.
, BMJ-British Medical Journal, Vol: 375, ISSN: 1756-1833 -
Journal articleGreenbury SF, Longford N, Ougham K, et al., 2021,
Changes in neonatal admissions, care processes and outcomes in England and Wales during the COVID-19 pandemic: a whole population cohort study
, BMJ Open, Vol: 11, ISSN: 2044-6055Objectives: The COVID-19 pandemic instigated multiple societal and healthcare interventions with potential to affect perinatal practice. We evaluated population-level changes in preterm and full-term admissions to neonatal units, care processes and outcomes.Design: Observational cohort study using the UK National Neonatal Research Database.Setting: England and Wales.Participants: Admissions to National Health Service neonatal units from 2012 to 2020.Main outcome measures: Admissions by gestational age, ethnicity and Index of Multiple Deprivation, and key care processes and outcomes.Methods: We calculated differences in numbers and rates between April and June 2020 (spring), the first 3 months of national lockdown (COVID-19 period), and December 2019–February 2020 (winter), prior to introduction of mitigation measures, and compared them with the corresponding differences in the previous 7 years. We considered the COVID-19 period highly unusual if the spring–winter difference was smaller or larger than all previous corresponding differences, and calculated the level of confidence in this conclusion.Results: Marked fluctuations occurred in all measures over the 8 years with several highly unusual changes during the COVID-19 period. Total admissions fell, having risen over all previous years (COVID-19 difference: −1492; previous 7-year difference range: +100, +1617; p<0.001); full-term black admissions rose (+66; −64, +35; p<0.001) whereas Asian (−137; −14, +101; p<0.001) and white (−319; −235, +643: p<0.001) admissions fell. Transfers to higher and lower designation neonatal units increased (+129; −4, +88; p<0.001) and decreased (−47; −25, +12; p<0.001), respectively. Total preterm admissions decreased (−350; −26, +479; p<0.001). The fall in extremely preterm admissions was most marked in the two lowest socioeconomic quintiles.Conclusions: Our findings indicate substantia
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Journal articleKimpton J, Verma A, Thakkar D, et al., 2021,
Comparison of NICE Guideline CG149 and the Sepsis Risk Calculator for the management of early onset sepsis on the postnatal ward
, Neonatology: foetal and neonatal research, Vol: 118, Pages: 562-568, ISSN: 1661-7800Introduction: NICE guideline CG149 has increased the number of well infants receiving antibiotics for suspected early onset sepsis (EOS). The Kaiser Permanente sepsis risk calculator (SRC) has safely and dramatically reduced investigations and antibiotics for suspected EOS in the USA. This study evaluates current management of suspected EOS against NICE guideline CG149 and the SRC. Methods: Prospective, multicentre, observational study across 13 neonatal units in London. Infants were born between June and August 2019 >34 weeks gestation and commenced on antibiotics for suspected EOS and cared for on postnatal/transitional care wards. Data were prospectively recorded: risk factors, clinical indicators, investigations and results. Outcome measures: 1) Incidence of EOS. 2) Proportion of infants recommended for antibiotics by NICE versus theoretical application of SRC. Results: 1066/8856 (12%) infants on postnatal/transitional care wards received antibiotics, 7 of whom had a positive blood culture (group B Streptococcus = 6, Escherichia coli = 1), making the EOS incidence 0.8/1000 infants. 601 infants had data for SRC analysis, which recommended “antibiotics” or “blood culture” for 130/601 (21.6%) infants using an EOS incidence of 0.5/1000 vs 527/601 (87.7%) if NICE was applied. Conclusions: Currently 12.0% of infants on postnatal/transitional care wards receive antibiotics for suspected EOS. The SRC could dramatically reduce antibiotic use but further prospective studies are required to evaluate safety of SRC implementation.
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Journal articleGreenbury SF, Angelini ED, Ougham K, et al., 2021,
Birthweight and patterns of postnatal weight gain in very and extremely preterm babies in England and Wales, 2008-19: a cohort study
, The Lancet Child & Adolescent Health, Vol: 5, Pages: 719-728, ISSN: 2352-4642BACKGROUND: Intrauterine and postnatal weight are widely regarded as biomarkers of fetal and neonatal wellbeing, but optimal weight gain following preterm birth is unknown. We aimed to describe changes over time in birthweight and postnatal weight gain in very and extremely preterm babies, in relation to major morbidity and healthy survival. METHODS: In this cohort study, we used whole-population data from the UK National Neonatal Research Database for infants below 32 weeks gestation admitted to neonatal units in England and Wales between Jan 1, 2008, and Dec 31, 2019. We used non-linear Gaussian process to estimate monthly trends, and Bayesian multilevel regression to estimate unadjusted and adjusted coefficients. We evaluated birthweight; weight change from birth to 14 days; weight at 36 weeks postmenstrual age; associated Z scores; and longitudinal weights for babies surviving to 36 weeks postmenstrual age with and without major morbidities. We adjusted birthweight for antenatal, perinatal, and demographic variables. We additionally adjusted change in weight at 14 days and weight at 36 weeks postmenstrual age, and their Z scores, for postnatal variables. FINDINGS: The cohort comprised 90 817 infants. Over the 12-year period, mean differences adjusted for antenatal, perinatal, demographic, and postnatal variables were 0 g (95% compatibility interval -7 to 7) for birthweight (-0·01 [-0·05 to 0·03] for change in associated Z score); 39 g (26 to 51) for change in weight from birth to 14 days (0·14 [0·08 to 0·19] for change in associated Z score); and 105 g (81 to 128) for weight at 36 weeks postmenstrual age (0·27 [0·21 to 0·33] for change in associated Z score). Greater weight at 36 weeks postmenstrual age was robust to additional adjustment for enteral nutritional intake. In babies surviving without major morbidity, weight velocity in all gestational age groups stabilised at around 34 weeks post
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Journal articleDucey J, Kennedy A, Linsell L, et al., 2022,
Timing of neonatal stoma closure: a survey of health professional perspectives and current practice
, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 107, ISSN: 1359-2998Optimal timing for neonatal stoma closure remains unclear. In this study we aimed to establish currentpractice and illustrate multidisciplinary perspectives on timing of stoma closure using an online survey sentto all 27 UK neonatal surgical units, as part of a research programme to determine feasibility of a clinical trialcomparing ‘early’ and ‘late’ stoma closure. 166 responses from all 27 units demonstrated concordance ofopinion in target time for closure (6 weeks most commonly stated across scenarios), although there washigh variability in practice. A sizeable proportion (41%) of respondents use weight, rather than time, todetermine when to close a neonatal stoma. Thematic analysis of free-text responses identified 9 key themesinfluencing decision making; most related to nutrition, growth and stoma complications. These data providean overview of current practice that is critical to informing an acceptable trial design.
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