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Journal articleRees P, Carter B, Gale C, et al., 2021,
Cost of neonatal abstinence syndrome: an economic analysis of English national data held in the National Neonatal Research Database
, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 106, Pages: 494-500, ISSN: 1359-2998Objective To determine the incidence of neonatal abstinence syndrome (NAS) across neonatal units, explore healthcare utilisation and estimate the direct cost to the NHS.Design Population cohort study.Setting NHS neonatal units, using data held in the National Neonatal Research Database.Participants Infants born between 2012 and 2017, admitted to a neonatal unit in England, receiving a diagnosis of NAS (n=6411).Main outcome measures Incidence, direct annual cost of care (£, 2016–2017 prices), duration of neonatal unit stay (discharge HR), predicted additional cost of care, and odds of receiving pharmacotherapy.Results Of 524 334 infants admitted during the study period, 6411 had NAS. The incidence (1.6/1000 live births) increased between 2012 and 2017 (β=0.07, 95% CI (0 to 0.14)) accounting for 12/1000 admissions and 23/1000 cot days nationally. The direct cost of care was £62 646 661 over the study period. Almost half of infants received pharmacotherapy (n=2631; 49%) and their time-to-discharge was significantly longer (median 18.2 vs 5.1 days; adjusted HR (aHR) 0.16, 95% CI (0.15 to 0.17)). Time-to-discharge was longer for formula-fed infants (aHR 0.73 (0.66 to 0.81)) and those discharged to foster care (aHR 0.77 (0.72 to 0.82)). The greatest predictor of additional care costs was receipt of pharmacotherapy (additional mean adjusted cost of £8420 per infant).Conclusions This population study highlights the substantial cot usage and economic costs of caring for infants with NAS on neonatal units. A shift in how healthcare systems provide routine care for NAS could benefit infants and families while alleviating the burden on services.
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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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Journal articleHage L, Jeyakumaran D, Dorling J, et al., 2021,
Changing clinical characteristics of infants treated for hypoxic ischaemic encephalopathy in England, Wales and Scotland: a population-based study using the National Neonatal Research Database
, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 106, Pages: 501-508, ISSN: 1359-2998Background Therapeutic hypothermia is standard of care for babies with moderate/severe hypoxic-ischaemic encephalopathy and is increasingly used for mild encephalopathy.Objective Describe temporal trends in the clinical condition of babies diagnosed with hypoxic-ischaemic encephalopathy who received therapeutic hypothermia.Design Retrospective cohort study using data held in the National Neonatal Research Database.Setting National Health Service neonatal units in England, Wales and Scotland.Patients Infants born from 1 January 2010 to 31 December 2017 with a recorded diagnosis of hypoxic-ischaemic encephalopathy who received therapeutic hypothermia for at least 3 days or died in this period.Main outcomes Primary outcomes: recorded clinical characteristics including umbilical cord pH; Apgar score; newborn resuscitation; seizures and treatment on day 1. Secondary outcomes: recorded hypoxic-ischaemic encephalopathy grade.Results 5201 babies with a diagnosis of hypoxic-ischaemic encephalopathy received therapeutic hypothermia or died; annual numbers increased over the study period. A decreasing proportion had clinical characteristics of severe hypoxia ischaemia or a diagnosis of moderate or severe hypoxic-ischaemic encephalopathy, trends were statistically significant and consistent across multiple clinical characteristics used as markers of severity.Conclusions Treatment with therapeutic hypothermia for hypoxic-ischaemic encephalopathy has increased in England, Scotland and Wales. An increasing proportion of treated infants have a diagnosis of mild hypoxic-ischaemic encephalopathy or have less severe clinical markers of hypoxia. This highlights the importance of determining the role of hypothermia in mild hypoxic-ischaemic encephalopathy. Receipt of therapeutic hypothermia is unlikely to be a useful marker for assessing changes in the incidence of brain injury over time.
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Journal articlePinchefsky EF, Schneider J, Basu S, et al., 2021,
Nutrition and management of glycemia in neonates with neonatal encephalopathy treated with hypothermia
, Seminars in Fetal and Neonatal Medicine, Vol: 26, ISSN: 1084-2756Adequate nutrition and glycemic homeostasis are increasingly recognized as potentially neuroprotective for the developing brain. In the context of hypoxia-ischemia, evidence is scarce regarding optimal nutritional support and administration route, as well as the short- and long-term consequences of such interventions. In this review, we summarize current knowledge on disturbances of brain metabolism of glucose and substrates by hypoxia-ischemia, and compound effects of these mechanisms on brain injury characterized by specific patterns on EEG and MRI. Risks and benefits of nutrition delivery via parenteral or enteral routes are examined. Nutrition could mitigate adverse neurodevelopmental outcomes, and the impact of nutritional strategies and specific nutritional interventions are reviewed. Limited literature highlights the need for further studies to understand the changes in energy metabolism during and after hypoxic-ischemic injury, to optimize nutritional regimens and glucose management, and to inform the neuroprotective role of nutrition.
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Journal articleFleming PF, Gale C, Molloy EJ, et al., 2021,
Paediatric research in the times of COVID-19
, Pediatric Research, Vol: 90, Pages: 267-271, ISSN: 0031-3998The COVID-19 pandemic poses many direct and indirect consequences for children’s health and associated research. Direct consequences include participation of children in COVID-19 research trials, pausing other research in children and the potential implications of a global economic downturn on future research funding. Collaborative and networked research together with streamlined research processes and use of remote technology have been central to efforts by clinicians and scientists around the world and have proved essential for reducing COVID-19 morbidity and mortality.
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Journal articleMcCarthy M, O'Keeffe L, Williamson PR, et al., 2021,
A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE) [version 1; peer review: 2 approved]
, HRB Open Research, Vol: 4, ISSN: 2515-4826Background: Protocols are an essential document for conducting randomised controlled trials (RCTs). However, the completeness of the information provided is often inadequate. To help improve the content of trial protocols, an international group of stakeholders published the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Initiative in 2013. Presently, there is increasing use of cohorts and routinely collected data (RCD) for RCTs because these data have the potential to improve efficiencies by facilitating recruitment, simplifying, and reducing the cost of data collection. Reporting guidelines have been shown to improve the quality of reporting, but there is currently no specific SPIRIT guidance on protocols for trials conducted using cohorts and RCD. This protocol outlines steps for developing SPIRIT-ROUTINE, which aims to address this gap by extending the SPIRIT guidance to protocols for trials conducted using cohorts and RCD. Methods: The development of the SPIRIT-ROUTINE extension comprises five stages. Stage 1 consists of a project launch and a meeting to finalise the membership of the steering group and scope of the extension. In Stage 2, a rapid review will be performed to identify possible modifications to the original SPIRIT 2013 checklist. Other key reporting guidelines will be reviewed to identify areas where additional items may be needed, such as the Consolidated Standards of Reporting Trials (CONSORT) extension for trials conducted using cohorts and RCD (CONSORT-ROUTINE). Stage 3 will involve an online Delphi exercise, consisting of two rounds and involving key international stakeholders to gather feedback on the preliminary checklist items. In Stage 4, a consensus meeting of the SPIRIT-ROUTINE steering group will finalise the items to include in the extension. Stage 5 will involve the publication preparation and dissemination of
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Journal articleLammons W, Moss R, Battersby C, et al., 2021,
Incorporating parent, former patient, and clinician perspectives in the design of a national UK double-cluster, randomised controlled trial addressing uncertainties in preterm nutrition
, BMJ Paediatrics Open, Vol: 5, ISSN: 2399-9772Background: Comparative effectiveness randomised controlled trials are powerful tools to resolve uncertainties in existing treatments and care processes. We sought parent and patient perspectives on the design of a planned national, double-cluster randomised controlled trial (COLLABORATE) to resolve two longstanding uncertainties in preterm nutrition.Methods: We used qualitative focus groups and interviews with parents, former patients and clinicians. We followed the Consolidated Criteria for Reporting Qualitative Research checklist and conducted framework analysis, a specific methodology within thematic analysis.Results: We identified support for the trial’s methodology and vision, and elicited themes illustrating parents’ emotional needs in relation to clinical research. These were: relieving the pressure on mothers to breastfeed; opt-out consent as reducing parent stress; the desire for research to be a partnership between clinicians, parents and researchers; the value of presenting trial information in a collaborative tone; and in a format that allows assimilation by parents at their own pace. We identified anxiety and cognitive dissonance among some clinicians in which they recognised the uncertainties that justify the trial but felt unable to participate because of their strongly held views.Conclusions: The early involvement of parents and former patients identified the centrality of parents’ emotional needs in the design of comparative effectiveness research. These insights have been incorporated into trial enrolment processes and information provided to participants. Specific outputs were a two-sided leaflet providing very brief as well as more detailed information, and use of language that parents perceive as inclusive and participatory. Further work is warranted to support clinicians to address personal biases that inhibit trial participation.
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Journal articleGale C, Longford NT, Jeyakumaran D, et al., 2021,
Feeding during neonatal therapeutic hypothermia, assessed using routinely collected National Neonatal Research Database data: a retrospective, UK population-based cohort study
, The Lancet Child and Adolescent Health, Vol: 5, Pages: 408-416, ISSN: 2352-4642Background:Therapeutic hypothermia is standard of care in high-income countries for babies born with signs of hypoxic ischaemic encephalopathy, but optimal feeding during treatment is uncertain and practice is variable. This study aimed to assess the association between feeding during therapeutic hypothermia and clinically important outcomes.Methods:We did a population-level retrospective cohort study using the UK National Neonatal Research Database. We included all babies admitted to National Health Service neonatal units in England, Scotland, and Wales between Jan 1, 2010, and Dec 31, 2017, who received therapeutic hypothermia for 72 h or died during this period. For analysis, we created matched groups using propensity scores and compared outcomes in babies who were fed versus unfed enterally during therapeutic hypothermia. The primary outcome was severe necrotising enterocolitis, either confirmed at surgery or causing death. Secondary outcomes include pragmatically defined necrotising enterocolitis (a recorded diagnosis of necrotising enterocolitis in babies who received at least 5 consecutive days of antibiotics while also nil by mouth during their neonatal unit stay), late-onset infection (pragmatically defined as 5 consecutive days of antibiotic treatment commencing after day 3), survival to discharge, measures of breastmilk feeding, and length of stay in neonatal unit.Findings:6030 babies received therapeutic hypothermia, of whom 1873 (31·1%) were fed during treatment. Seven (0·1%) babies were diagnosed with severe necrotising enterocolitis and the number was too small for further analyses. We selected 3236 (53·7%) babies for the matched feeding analysis (1618 pairs), achieving a good balance for all recorded background variables. Pragmatically defined necrotising enterocolitis was rare in both groups (incidence 0·5%, 95% CI 0·2–0·9] in the fed group vs 1·1% [0·7–1·4] in the unfed grou
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Journal articleGale C, Jeyakumaran D, Battersby C, et al., 2021,
Nutritional management in newborn babies receiving therapeutic hypothermia: two retrospective observational studies using propensity score matching
, Health Technology Assessment, Vol: 25, Pages: 1-106, ISSN: 1366-5278BACKGROUND: Therapeutic hypothermia is standard of care for babies with moderate to severe hypoxic-ischaemic encephalopathy. There is limited evidence to inform provision of nutrition during hypothermia. OBJECTIVES: To assess the association during therapeutic hypothermia between (1) enteral feeding and outcomes, such as necrotising enterocolitis and (2) parenteral nutrition and outcomes, such as late-onset bloodstream infection. DESIGN: A retrospective cohort study using data held in the National Neonatal Research Database and applying propensity score methodology to form matched groups for analysis. SETTING: NHS neonatal units in England, Wales and Scotland. PARTICIPANTS: Babies born at ≥ 36 gestational weeks between 1 January 2010 and 31 December 2017 who received therapeutic hypothermia for 72 hours or who died during treatment. INTERVENTIONS: Enteral feeding analysis - babies who were enterally fed during therapeutic hypothermia (intervention) compared with babies who received no enteral feeds during therapeutic hypothermia (control). Parenteral nutrition analysis - babies who received parenteral nutrition during therapeutic hypothermia (intervention) compared with babies who received no parenteral nutrition during therapeutic hypothermia (control). OUTCOME MEASURES: Primary outcomes were severe and pragmatically defined necrotising enterocolitis (enteral feeding analysis) and late-onset bloodstream infection (parenteral nutrition analysis). Secondary outcomes were survival at neonatal discharge, length of neonatal stay, breastfeeding at discharge, onset of breastfeeding, time to first maternal breast milk, hypoglycaemia, number of days with a central line in situ, duration of parenteral nutrition, time to full enteral feeds and growth. RESULTS: A total of 6030 babies received therapeutic hypothermia. Thirty-one per cent of babies received enteral feeds and 25% received parenteral nutrition. Seven babies (0.1%) were diagnosed with severe necrotising e
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Journal articleGale C, Longford N, Jeyakumaran D, et al., 2021,
Feeding during neonatal therapeutic hypothermia: a retrospective population-based cohort study using routinely collected data held in the National Neonatal Research Database
, The Lancet Child and Adolescent Health, Vol: 5, ISSN: 2352-4642Background: There is limited evidence to inform feeding during neonatal therapeutic hypothermia; practice is variable. We aimed assess the association between feeding during therapeutic hypothermia and clinically important outcomes.Methods: Retrospective, population-based cohort study using the National Neonatal Research Database. We included all babies admitted to NHS neonatal units in England, Scotland or Wales, 1 January 2010 – 31 December 2017, that received therapeutic hypothermia for 72 hours or died during treatment. We formed matched groups for analysis using propensity scores and compared outcomes in babies fed during therapeutic hypothermia to those that were not. The primary outcome was severe necrotising enterocolitis confirmed at surgery or causing death; we also described pragmatically defined necrotising enterocolitis including lower severity disease, infection, survival, hypoglycaemia, parenteral nutrition and central line days, measures of breastmilk feeding, length of stay and weight. Pre-registered ISRCTN47404296.Findings: 6030 babies received therapeutic hypothermia and 1873 (31%) were fed during hypothermia. Seven babies (0·1%) were diagnosed with severe necrotising enterocolitis. 3236 babies were selected for the matched feeding analysis (1618 pairs) and good balance was achieved for all recorded background variables. Pragmatically defined necrotising enterocolitis was rare both fed and not fed groups (0·6% and 1·1% respectively). Higher survival to discharge (difference 5·2%; 95% CI: 3·9, 6·6; p<0·0001) and breastfeeding at discharge (difference 8·0%; 95% CI: 5·1, 10·8; p<0·0001) were seen in fed babies, who also had shorter neonatal stays (difference -2·2 days, 95% CI: -3·0, -1·2; p<0.0001). Interpretation: Necrotising enterocolitis is rare in babies receiving therapeutic hypothermia. Feeding during hypothermia is associated with l
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