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Journal articleGreenbury SF, Angelini DE, Ougham K, et al., 2022,
Post-natal growth of very preterm neonates
, The Lancet Child & Adolescent Health, Vol: 6, Pages: E11-E11, ISSN: 2352-4642 -
Journal articleVousden N, Ramakrishnan R, Bunch K, et al., 2022,
Management and implications of severe COVID-19 in pregnancy in the UK: data from the UK Obstetric Surveillance System national cohort
, Acta Obstetricia et Gynecologica Scandinavica, Vol: 101, ISSN: 0001-6349INTRODUCTION: There is a lack of population level data on risk factors and impact of severe COVID-19 in pregnancy. The aims of this study were to determine the characteristics, and maternal and perinatal outcomes associated with severe COVID-19 in pregnancy compared with those with mild and moderate COVID-19 and to explore the impact of timing of birth. MATERIAL AND METHODS: This was a secondary analysis of a national, prospective cohort study. All pregnant women admitted to hospital in the UK with symptomatic SARS-CoV-2 from March 1, 2020 to October 31, 2021 were included. The severity of maternal infection (need for high flow or invasive ventilation, intensive care admission or died), pregnancy and perinatal outcomes, and the impact of timing of birth were analyzed using multivariable logistic regression. RESULTS: Of 4436 pregnant women, 13.9% (n = 616) had severe infection. Women with severe infection were more likely to be aged ≥30 years (adjusted odds ratio [aOR] aged 30-39 1.48, 95% confidence interval [CI] 1.20-1.83), be overweight or obese (aOR 1.73, 95% CI 1.34-2.25 and aOR 2.52 95% CI 1.97-3.23, respectively), be of mixed ethnicity (aOR 1.93, 95% CI 1.17-3.21) or have gestational diabetes (aOR 1.43, 95% CI 1.09-1.87) compared with those with mild or moderate infection. Women with severe infection were more likely to have a pre-labor cesarean birth (aOR 8.84, 95% CI 6.61-11.83), a very or extreme preterm birth (28-31+ weeks' gestation, aOR 18.97, 95% CI 7.78-14.85; <28 weeks' gestation, aOR 12.35, 95% CI 6.34-24.05) and their babies were more likely to be stillborn (aOR 2.51, 95% CI 1.35-4.66) or admitted to a neonatal unit (aOR 11.61, 95% CI 9.28-14.52). Of 112 women with severe infection who were discharged and gave birth at a later admission, the majority gave birth ≥36 weeks (85.7%), noting that three women in this group (2.7%) had a stillbirth. CONCLUSIONS: Severe COVID-19 in pregnancy increases the risk of advers
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Journal articleWebbe J, Longford N, Battersby C, et al., 2022,
Outcomes in relation to early parenteral nutrition use in preterm neonates born between 30 and 33 weeks gestation: a propensity score matched observational study
, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 107, Pages: 131-136, ISSN: 1359-2998ObjectiveTo evaluate whether in preterm neonates parenteral nutrition use in the first sevenpostnatal days, compared with no parenteral nutrition use, is associated withdifferences in survival and other important morbidities. Randomised trials in criticallyill older children show that harms, such as nosocomial infection, outweigh benefits ofearly parenteral nutrition administration; there is a paucity of similar data inneonates.DesignRetrospective cohort study using propensity matching including 35 maternal, infantand organisational factors to minimise bias and confounding.SettingNational, population-level clinical data obtained for all National Health Serviceneonatal units in England and Wales.PatientsPreterm neonates born between 30+0 and 32+6 weeks+days.InterventionsThe exposure was parenteral nutrition administered in the first seven days ofpostnatal life; the comparator was no parenteral nutrition.Main outcome measuresThe primary outcome was survival to discharge from neonatal care. Secondaryoutcomes comprised the neonatal core outcome set.Results16,292 neonates were compared in propensity score matched analyses. Comparedwith matched neonates not given parenteral nutrition in the first postnatal week, neonates who received parenteral nutrition had higher survival at discharge(absolute rate increase 0.91%; 95% CI 0.53% to 1.30%), but higher rates ofnecrotising enterocolitis (absolute rate increase 4.6%), bronchopulmonary dysplasia(absolute rate increase 3.9%), late-onset sepsis (absolute rate increase 1.5%) andneed for surgical procedures (absolute rate increase 0.92%).ConclusionsIn neonates born between 30+0 and 32+6 weeks gestation, those given parenteralnutrition in the first postnatal week had a higher rate of survival but higher rates ofimportant neonatal morbidities. Clinician equipoise in this area should be resolvedby prospective, randomised trials.
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Journal articleUthaya S, Longford N, Battersby C, et al., 2022,
Early versus later initiation of parenteral nutrition for very preterm infants: a propensity score matched observational study
, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 107, ISSN: 1359-2998Background: A current standard of care based on expert opinion is to commence parenteral nutrition (PN) within hours of birth in very preterm infants. Trials in critically ill adults and children, including term infants have found short and long-term harms from early initiation of PN. Methods: We included all infants born below 31 weeks gestation between January 2008 and December 2019 and admitted to National Health Service neonatal units in England and Wales. The source of data was the National Neonatal Research Database. The exposure was PN initiated within the first two days after birth (early) versus after the second postnatal day (late). We used propensity matched analysis to balance the two groups on background variables. The primary outcome was survival to discharge without major morbidity. Findings: Of 65,033 infants included, 16,294 infants formed the matched cohort, 8147 in each group. There was no evidence of a difference in survival to discharge without major morbidity (absolute rate difference (ARD) between early versus late 0·50%; 95% Confidence Interval (CI), -1·45, 0·45; p=0·29). Survival to discharge was higher in the early group (ARD -3·25%; 95% CI, -3·82 to -2·68; p<0·001) but they also had higher rates of late-onset sepsis (ARD -0·84%; 95% CI, -1·20 to -0·48; p<0·001), bronchopulmonary dysplasia (ARD -1·24%; 95% CI, -2·17 to -0·30; p=0·01), treatment for retinopathy of prematurity (ARD (-0·5%; 95% CI, -0·84 to -0.17; p<0·001), surgical procedures (ARD -0·8%; 95% CI, -1·40 to -0·20; p=0·01) and greater drop in weight z-score between birth and discharge (absolute difference 0·019; 95% CI, 0·003 to 0·039; p=0·02). Among infants that died the median age (days) at death was shorter in the late group (ARD 6; 95% CI, 6; p<0.001). Interpretation: These o
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Journal articleLi Y, kurinczuk JJ, Gale C, et al., 2022,
Evidence of disparities in the provision of the maternal postpartum six week check in primary care in England, 2015- 2018: an observational study using the Clinical Practice Research Datalink (CPRD)
, Journal of Epidemiology and Community Health, Vol: 76, Pages: 239-246, ISSN: 0143-005XBackground A maternal postpartum six-week check (SWC) with a General Practitioner (GP) is now considered an essential service in England, a recent policy change intended to improve women’s health. We aimed to provide an up-to-date snapshot of the prevalence of SWC prior to the policy change as a baseline, and to explore factors associated with having a late or no check. Methods We conducted a cohort study using primary care records in England (Clinical Practice Research Datalink (CPRD)). 34,337 women who gave birth between 1st July 2015 and 30th June 2018 and had ≥12 weeks of follow-up postpartum, were identified in the CPRD Pregnancy Register. The proportion who had evidence of a SWC with a GP was calculated, and regression analysis was used to assess the association between women’s characteristics and risks of a late or no check.Results Sixty-two percent (95%CI: 58%-67%) of women had a SWC recorded at their GP practice within 12 weeks postpartum, another 27% had other consultations. Forty percent had a SWC at the recommended 6-8 weeks, 2% earlier and 20% later. A late or no check was more common among younger women, mothers of preterm babies, or those registered in more deprived areas.Conclusions Nearly 40% of women did not have a postpartum SWC recorded. Provision or uptake was not equitable; younger women and those in more deprived areas were less likely to have a record of such check, suggesting postpartum care in general practice may be missing some women who need it most.
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Journal articleAshworth D, Battersby C, Green M, et al., 2022,
Which antihypertensive treatment is better for mild to moderate hypertension in pregnancy?
, BMJ: British Medical Journal, Vol: 376, Pages: 1-4, ISSN: 0959-535X -
Journal articleHenry CJ, Semova G, Barnes E, et al., 2022,
Neonatal sepsis: a systematic review of core outcomes from randomised clinical trials
, Pediatric Research, Vol: 91, ISSN: 0031-3998BACKGROUND: The lack of a consensus definition of neonatal sepsis and a core outcome set (COS) proves a substantial impediment to research that influences policy and practice relevant to key stakeholders, patients and parents. METHODS: A systematic review of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. In the included studies, the described outcomes were extracted in accordance with the provisions of the Core Outcome Measures in Effectiveness Trials (COMET) handbook and registered. RESULTS: Among 884 abstracts identified, 90 randomised controlled trials (RCTs) were included in this review. Only 30 manuscripts explicitly stated the primary and/or secondary outcomes. A total of 88 distinct outcomes were recorded across all 90 studies included. These were then assigned to seven different domains in line with the taxonomy for classification proposed by the COMET initiative. The most frequently reported outcome was survival with 74% (n = 67) of the studies reporting an outcome within this domain. CONCLUSIONS: This systematic review constitutes one of the initial phases in the protocol for developing a COS in neonatal sepsis. The paucity of standardised outcome reporting in neonatal sepsis hinders comparison and synthesis of data. The final phase will involve a Delphi Survey to generate a COS in neonatal sepsis by consensus recommendation. IMPACT: This systematic review identified a wide variation of outcomes reported among published RCTs on the management of neonatal sepsis. The paucity of standardised outcome reporting hinders comparison and synthesis of data and future meta-analyses with conclusive recommendations on the management of neonatal sepsis are unlikely. The final phase will involve a Delphi Survey to determine a COS by consensus recommendation with input from all relevant stakeholders.
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Journal articleImran M, McCord K, McCall SJ, et al., 2022,
Reporting transparency and completeness in trials: Paper 3 - trials conducted using administrative databases do not adequately report elements related to use of databases
, Journal of Clinical Epidemiology, Vol: 141, Pages: 187-197, ISSN: 0895-4356Objective: We evaluated reporting completeness and transparency in randomised controlled trials (RCTs) conducted using administrative data based on 2021 CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria.Study Design and Setting: MEDLINE and the Cochrane Methodology Register were searched (2011 and 2018). Eligible RCTs used administrative databases for identifying eligible participants or collecting outcomes. We evaluated reporting based on CONSORT-ROUTINE, which modified eight items from CONSORT 2010 and added five new items.Results: Of 33 included trials (76% used administrative databases for outcomes, 3% for identifying participants, 21% both), most were conducted in the United States (55%), Canada (18%), or the United Kingdom (12%). Of eight items modified in the extension; six were adequately reported in a majority (>50%) of trials. For the CONSORT-ROUTINE modification portion of those items, three items were reported adequately in >50% of trials, two in <50%, two only applied to some trials, and one only had wording modifications and was not evaluated. For five new items, four that address use of routine data in trials were reported inadequately in most trials. Conclusion: How administrative data are used in trials is often sub-optimally reported. CONSORT-ROUTINE uptake may improve reporting.
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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 articleMalouf R, Harrison S, Burton HAL, et al., 2022,
Prevalence of anxiety and post-traumatic stress (PTS) among the parents of babies admitted to neonatal units: a systematic review and meta-analysis
, EClinicalMedicine, Vol: 43, ISSN: 2589-5370BackgroundParents of babies admitted to neonatal units (NNU) are exposed to a range of potentially distressing experiences, which can lead to mental health symptoms such as increased anxiety and post-traumatic stress (PTS). This review aimed to describe how anxiety and PTS are defined and assessed, and to estimate anxiety and PTS prevalence among parents of babies admitted to NNU.MethodMedline, Embase, PsychoINFO, Cumulative Index to Nursing and Allied Health literature were searched to identify studies published prior to April 14, 2021. Included studies were assessed using Hoy risk of bias tool. A random-effects model was used to estimate pooled prevalence with 95% CIs. Potential sources of variation were investigated using subgroup analyses and meta-regression. The review is registered with PROSPERO (CRD42020162935).FindingsFifty six studies involving 6,036 parents met the review criteria; 21 studies assessed anxiety, 35 assessed PTS, and 8 assessed both. The pooled prevalence of anxiety was 41.9% (95%CI:30.9, 53.0) and the pooled prevalence of PTS was 39.9% (95%CI:30.8, 48.9) among parents up to one month after the birth. Anxiety prevalence decreased to 26.3% (95%CI:10.1, 42.5) and PTS prevalence to 24.5% (95%CI:17.4, 31.6) between one month and one year after birth. More than one year after birth PTS prevalence remained high 27.1% (95%CI:20.7, 33.6). Data on anxiety at this time point were limited. There was high heterogeneity between studies and some evidence from subgroup and meta-regression analyses that study characteristics contributed to the variation in prevalence estimates.InterpretationThe prevalence of anxiety and PTS was high among parents of babies admitted to NNU. The rates declined over time, although they remained higher than population prevalence estimates for women in the perinatal period. Implementing routine screening would enable early diagnosis and effective intervention.FundingThis research is funded by the National Institute for Health Res
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