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Journal articleGale C, Knight M, Ladhani S, et al., 2020,
National active surveillance to understand and inform neonatal care in COVID-19
, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 105, Pages: 346-347, ISSN: 1359-2998 -
Journal articleKnight M, Bunch K, Vousden N, et al., 2020,
Characteristics and outcomes of pregnant women admitted to hospital with confirmed SARS-CoV-2 infection in UK: national population based cohort study.
, BMJ, Vol: 369, Pages: 1-7, ISSN: 1759-2151OBJECTIVES: To describe a national cohort of pregnant women admitted to hospital with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the UK, identify factors associated with infection, and describe outcomes, including transmission of infection, for mothers and infants. DESIGN: Prospective national population based cohort study using the UK Obstetric Surveillance System (UKOSS). SETTING: All 194 obstetric units in the UK. PARTICIPANTS: 427 pregnant women admitted to hospital with confirmed SARS-CoV-2 infection between 1 March 2020 and 14 April 2020. MAIN OUTCOME MEASURES: Incidence of maternal hospital admission and infant infection. Rates of maternal death, level 3 critical care unit admission, fetal loss, caesarean birth, preterm birth, stillbirth, early neonatal death, and neonatal unit admission. RESULTS: The estimated incidence of admission to hospital with confirmed SARS-CoV-2 infection in pregnancy was 4.9 (95% confidence interval 4.5 to 5.4) per 1000 maternities. 233 (56%) pregnant women admitted to hospital with SARS-CoV-2 infection in pregnancy were from black or other ethnic minority groups, 281 (69%) were overweight or obese, 175 (41%) were aged 35 or over, and 145 (34%) had pre-existing comorbidities. 266 (62%) women gave birth or had a pregnancy loss; 196 (73%) gave birth at term. Forty one (10%) women admitted to hospital needed respiratory support, and five (1%) women died. Twelve (5%) of 265 infants tested positive for SARS-CoV-2 RNA, six of them within the first 12 hours after birth. CONCLUSIONS: Most pregnant women admitted to hospital with SARS-CoV-2 infection were in the late second or third trimester, supporting guidance for continued social distancing measures in later pregnancy. Most had good outcomes, and transmission of SARS-CoV-2 to infants was uncommon. The high proportion of women from black or minority ethnic groups admitted with infection needs urgent investigation and explanation. STUDY REGISTRATION: ISRCTN 4
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Journal articleModi N, 2020,
Children first, or last?
, EBIOMEDICINE, Vol: 56, ISSN: 2352-3964- Author Web Link
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- Citations: 1
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Journal articleTume LN, Woolfall K, Arch B, et al., 2020,
Routine gastric residual volume measurement to guide enteral feeding in mechanically ventilated infants and children: the GASTRIC feasibility study
, Health Technology Assessment, Vol: 24, Pages: 1-122, ISSN: 1366-5278BackgroundThe routine measurement of gastric residual volume to guide the initiation and delivery of enteral feeding is widespread in paediatric intensive care and neonatal units, but has little underlying evidence to support it.ObjectiveTo answer the question: is a trial of no gastric residual volume measurement feasible in UK paediatric intensive care units and neonatal units?DesignA mixed-methods study involving five linked work packages in two parallel arms: neonatal units and paediatric intensive care units. Work package 1: a survey of units to establish current UK practice. Work package 2: qualitative interviews with health-care professionals and caregivers of children admitted to either setting. Work package 3: a modified two-round e-Delphi survey to investigate health-care professionals’ opinions on trial design issues and to obtain consensus on outcomes. Work package 4: examination of national databases to determine the potential eligible populations. Work package 5: two consensus meetings of health-care professionals and parents to review the data and agree consensus on outcomes that had not reached consensus in the e-Delphi study.Participants and settingParents of children with experience of ventilation and tube feeding in both neonatal units and paediatric intensive care units, and health-care professionals working in neonatal units and paediatric intensive care units.ResultsBaseline surveys showed that the practice of gastric residual volume measurement was very common (96% in paediatric intensive care units and 65% in neonatal units). Ninety per cent of parents from both neonatal units and paediatric intensive care units supported a future trial, while highlighting concerns around possible delays in detecting complications. Health-care professionals also indicated that a trial was feasible, with 84% of staff willing to participate in a trial. Concerns expressed by junior nurses about the intervention arm of not measuring gastric residual volumes
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Journal articleWadon M, Modi N, Wong HS, et al., 2020,
Recent advances in the genetics of preterm birth
, ANNALS OF HUMAN GENETICS, Vol: 84, Pages: 205-213, ISSN: 0003-4800- Author Web Link
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- Citations: 13
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Journal articleGale C, McGuire W, Juszczak E, 2020,
Randomised controlled trials for informing perinatal care
, Neonatology, Vol: 117, Pages: 8-14, ISSN: 1661-7800BACKGROUND: Randomised controlled trials provide the best evidence for the effects of interventions and are a key tool in the effort to improve the care and outcomes for newborn infants. METHODS: We discuss the role of randomisation for minimising selection bias in clinical trials and describe examples of seminal trials that have shaped the development of modern perinatal care. We consider the challenges inherent in designing and delivering large, simple, and pragmatic trials, and the need for the development and adoption of core outcome sets to ensure that trials provide high-quality evidence of sufficient validity and applicability to guide policy and practice. RESULTS: Since the earliest days of modern neonatology, the randomised controlled trial has been recognised as the best method for assessing treatments and practices. While many strategies that reduce mortality and morbidity have been introduced following randomised trials, there are, however, important examples of ineffective or potentially harmful practices that have been adopted in the absence of trial-based evidence. Typically, randomised controlled trials in perinatal care need to recruit several thousand participants to be able to detect modest but potentially important effects of new interventions on the most important but rare outcomes. Given the concerns about the financial burden and regulatory complexity of standard trial designs, innovative "efficient" trial designs are being evaluated to streamline processes while safeguarding participants. CONCLUSIONS: Well-conducted randomised controlled trials provide the most robust evaluation of interventions aimed at improving outcomes for newborn infants and their families. Increasingly, these trials will need to be large and multicentre (often international) and use a simple and pragmatic protocol, incorporating meticulous follow-up procedures and assessment of long-term outcomes.
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Journal articleMedvedev MM, Brotherton H, Gai A, et al., 2020,
Development and validation of a simplified score to predict neonatal mortality risk among neonates weighing 2000 g or less (NMR-2000): an analysis using data from the UK and The Gambia.
, Lancet Child and Adolescent Health, Vol: 4, Pages: 299-311, ISSN: 2352-4642BACKGROUND: 78% of neonatal deaths occur in sub-Saharan Africa and southern Asia, among which, more than 80% are in low birthweight babies. Existing neonatal mortality risk scores have primarily been developed for high-resource settings. The aim of this study was to develop and validate a score that is practicable for low-income and middle-income countries to predict in-hospital mortality among neonates born weighing 2000 g or less using datasets from the UK and The Gambia. METHODS: This analysis used retrospective data held in the UK National Neonatal Research Database from 187 neonatal units, and data from the Edward Francis Small Teaching Hospital (EFSTH), Banjul, The Gambia. In the UK dataset, neonates were excluded if birthweight was more than 2000 g; if the neonate was admitted aged more than 6 h or following discharge; if the neonate was stillborn; if the neonate died in delivery room; or if they were moribund on admission. The Gambian dataset included all neonates weighing less than 2000 g who were admitted between May 1, 2018, and Sept 30, 2019, who were screened for but not enrolled in the Early Kangaroo Mother Care Trial. 18 studies were reviewed to generate a list of 84 potential parameters. We derived a model to score in-hospital neonatal mortality risk using data from 55 029 admissions to a random sample of neonatal units in England and Wales from Jan 1, 2010, to Dec 31, 2016. All candidate variables were included in a complete multivariable model, which was progressively simplified using reverse stepwise selection. We validated the new score (NMR-2000) on 40 329 admissions to the remaining units between the same dates and 14 818 admissions to all units from Jan 1, to Dec 31, 2017. We also validated the score on 550 neonates admitted to the EFSTH in The Gambia. FINDINGS: 18 candidate variables were selected for inclusion in the modelling process. The final model included three parameters: birthweight, admission oxygen saturation, and highest level of r
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Journal articleSakonidou S, Andrzejewska I, Webbe J, et al., 2020,
Interventions to improve quantitative measures of parent satisfaction in neonatal care: a systematic review
, BMJ Paediatrics Open, Vol: 4, ISSN: 2399-9772Objective: Interventions improving parent satisfaction can reduce parent stress, may improve parent-infant bonding and infant outcomes. Our objective was to systematically review neonatal interventions relating to parents of infants of all gestations where an outcome was parent satisfaction. Methods: We searched the databases MEDLINE, EMBASE, PsychINFO, Cochrane Central Register of Controlled Trials, CINAHL, HMIC, Maternity and Infant Care between 1 January 1946 and 1 October 2017. Inclusion criteria were randomised controlled trials (RCT), cohort studies and other non-randomised studies if participants were parents of infants receiving neonatal care, interventions were implemented in neonatal units (of any care level) and ≥1 quantitative outcome of parent satisfaction was measured. Included studies were limited to the English language only. We extracted study characteristics, interventions, outcomes and parent involvement in intervention design. Included studies were not sufficiently homogenous to enable quantitative synthesis. We assessed quality with the Cochrane Collaboration risk of bias tool (randomised) and the ROBINS-I tool (Risk Of Bias In Non-randomised Studies - of Interventions) (non-randomised studies). Results: We identified 32 studies with satisfaction measures from over 2800 parents and grouped interventions into 5 themes. Most studies were non-randomised involving preterm infants. Parent satisfaction was measured by 334 different questions in 29 questionnaires (only 6/29 fully validated). 18/32 studies reported higher parent satisfaction in the intervention group. The intervention theme with most studies reporting higher satisfaction was parent involvement (10/14). Five (5/32) studies reported involving parents in intervention design. All studies had high risk of bias. Conclusions: Many interventions, commonly relating to parent involvement, are reported to improve parent satisfaction. Inconsistency in satisfaction measurements and high risk of b
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Journal articleHelenius K, Longford N, Lehtonen L, et al., 2020,
Association of early postnatal transfer and birth outside a tertiary hospital with mortality and severe brain injury in extremely preterm infants: observational cohort study with propensity score matching
, Obstetrical and Gynecological Survey, Vol: 75, Pages: 145-147, ISSN: 0029-7828Approximately 1 in 20 preterm infants in high-income countries are born at less than 28 weeks' gestation with increased risk of death and morbidity. Previous studies have shown improved outcomes when care is provided in tertiary hospitals as compared with nontertiary hospitals; this study aims to examine the rate of adverse outcomes for those preterm infants who underwent postnatal transfer to a tertiary facility in England.
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Journal articleBrunton G, Webbe J, Oliver S, et al., 2020,
Adding value to core outcome set development using multi-method systematic reviews
, Research Synthesis Methods, Vol: 11, Pages: 248-259, ISSN: 1759-2879Trials evaluating the same interventions rarely measure or report identical outcomes. This limits the possibility of aggregating effect sizes across studies to generate high quality evidence through systematic reviews and meta-analyses. To address this problem, Core Outcome Sets (COS) establish agreed sets of outcomes to be used in all future trials. When developing COS, potential outcome domains are identified by systematically reviewing the outcomes of trials, and increasingly, through primary qualitative research exploring the experiences of key stakeholders, with relevant outcome domains subsequently determined through transdisciplinary consensus development. However, the primary qualitative component can be time consuming with unclear impact. We aimed to examine the potential added value of a qualitative systematic review alongside a quantitative systematic review of trial outcomes to inform COS development in neonatal care using case analysis methods.We compared the methods and findings of a scoping review of neonatal trial outcomes and a scoping review of qualitative research on parents', patients' and professional caregivers' perspectives of neonatal care. Together, these identified a wider range and greater depth of health and social outcome domains, some unique to each review, which were incorporated into the subsequent Delphi process and informed the final set of core outcome domains. Qualitative scoping reviews of participant perspectives research, used in conjunction with quantitative scoping reviews of trials, could identify more outcome domains for consideration and could provide greater depth of understanding to inform stakeholder group discussion in COS development. This is an innovation in the application of research synthesis methods. This article is protected by copyright. All rights reserved.
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