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Journal articleMcCall SJ, Imran M, Hemkens LG, et al., 2022,
Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records – room for improvement
, Journal of Clinical Epidemiology, Vol: 141, Pages: 198-209, ISSN: 0895-4356Objective:To describe characteristics of randomized controlled trials (RCTs) conducted using electronic health records (EHRs), including completeness and transparency of reporting assessed against the 2021 CONSORT Extension for RCTs Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria.Study Design:MEDLINE and Cochrane Methodology Register were searched for a sample of RCTs published from 2011–2018. Completeness of reporting was assessed in a random sample using a pre-defined coding form.Results:Of the 183 RCT publications identified, 122 (67%) used EHRs to identify eligible participants, 139 (76%) used the EHR as part of the intervention and 137 (75%) to ascertain outcomes. When 60 publications were evaluated against the CONSORT 2010 item and the corresponding extension for the 8 modified items, four items were 'adequately reported' for most trials. Five new reporting items were identified for the CONSORT-ROUTINE extension; when evaluated, one was ‘adequately reported’, three were reported ‘inadequately or not at all’, the other ‘partially’. There were, however, some encouraging signs with adequate and partial reporting of many important items, including descriptions of trial design, the consent process, outcome ascertainment and interpretation.Conclusion:Aspects of RCTs using EHRs are sub-optimally reported. Uptake of the CONSORT-ROUTINE Extension may improve reporting.
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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 articleRyan L, Ploetz FB, van den Hoogen A, et al., 2021,
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 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 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, 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 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 articleShipley L, Gale C, Sharkey D, 2021,
Trends in the incidence and management of hypoxic-ischaemic encephalopathy in the therapeutic hypothermia era: a national population study
, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 106, Pages: 529-534, ISSN: 1359-2998Objective Hypoxic-ischaemic encephalopathy (HIE) remains a leading cause of neonatal mortality and neurodisability. We aimed to determine the incidence of HIE and management patterns against national guidelines.Design Retrospective cohort study using the National Neonatal Research Database.Setting Neonatal units in England and Wales.Patients Infants 34–42 weeks gestational age (GA) with a recorded diagnosis of HIE.Main outcomes Incidence of HIE, mortality and treatment with therapeutic hypothermia (TH) were the main outcomes. Temporal changes were compared across two epochs (2011–2013 and 2014–2016).Results Among 407 462 infants admitted for neonatal care, 12 195 were diagnosed with HIE. 8166 infants ≥36 weeks GA had moderate/severe HIE, 62.1% (n=5069) underwent TH and mortality was 9.3% (n=762). Of infants with mild HIE (n=3394), 30.3% (n=1027) underwent TH and 6 died. In late preterm infants (34–35 weeks GA) with HIE (n=635, 5.2%), 33.1% (n=210) received TH and 13.1% (n=83) died. Between epochs (2011–2013 vs 2014–2016), mortality decreased for infants ≥36 weeks GA with moderate/severe HIE (17.5% vs 12.3%; OR 0.69, 95% CI 0.59 to 0.81, p<0.001). Treatment with TH increased significantly between epochs in infants with mild HIE (24.9% vs 35.8%, p<0.001) and those born late preterm (34.3% vs 46.6%, p=0.002).Conclusions Mortality of infants ≥36 weeks GA with moderate/severe HIE has reduced over time, although many infants diagnosed with moderate/severe HIE do not undergo TH. Increasingly, mild HIE and late preterm infants with HIE are undergoing TH, where the evidence base is lacking, highlighting the need for prospective studies to evaluate safety and efficacy in these populations.
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