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  • Journal article
    Gale C, Dorling J, Arch B, Woolfall K, Deja E, Roper L, Jones AP, Latten L, Eccleson H, Hickey H, Pathan N, Preston J, Beissel A, Andrzejewska I, Valla F, Tume Let al., 2021,

    Optimal outcome measures for a trial of not routinely measuring gastric residual volume in neonatal care: a mixed methods consensus process

    , Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 106, Pages: 292-297, ISSN: 1359-2998

    BACKGROUND: Routine measurement of gastric residual volume to guide feeding is widespread in neonatal units but not supported by high-quality evidence. Outcome selection is critical to trial design. OBJECTIVE: To determine optimal outcome measures for a trial of not routinely measuring gastric residual volume in neonatal care. DESIGN: A focused literature review, parent interviews, modified two-round Delphi survey and stakeholder consensus meeting. PARTICIPANTS: Sixty-one neonatal healthcare professionals participated in an eDelphi survey; 17 parents were interviewed. 19 parents and neonatal healthcare professionals took part in the consensus meeting. RESULTS: Literature review generated 14 outcomes, and parent interviews contributed eight additional outcomes; these 22 outcomes were then ranked by 74 healthcare professionals in the first Delphi round where four further outcomes were proposed; 26 outcomes were ranked in the second round by 61 healthcare professionals. Five outcomes were categorised as 'consensus in', and no outcomes were voted 'consensus out'. 'No consensus' outcomes were discussed and voted on in a face-to-face meeting by 19 participants, where four were voted 'consensus in'. The final nine consensus outcomes were: mortality, necrotising enterocolitis, time to full enteral feeds, duration of parenteral nutrition, time feeds stopped per 24 hours, healthcare-associated infection; catheter-associated bloodstream infection, change in weight between birth and neonatal discharge and pneumonia due to milk aspiration. CONCLUSIONS AND RELEVANCE: We have identified outcomes for a trial of no routine measurement of gastric residual volume to guide feeding in neonatal care. This outcome set will ensure outcomes are important to healthcare professionals and parents.

  • Journal article
    Modi N, Hanson M, 2021,

    Health of women and children is central to covid-19 recovery

    , BMJ-BRITISH MEDICAL JOURNAL, Vol: 373, ISSN: 0959-535X
  • Journal article
    Greenbury SF, Ougham K, Wu J, Battersby C, Gale C, Modi N, Angelini EDet al., 2021,

    Identification of variation in nutritional practice in neonatal units in England and association with clinical outcomes using agnostic machine learning

    , Scientific Reports, Vol: 11, ISSN: 2045-2322

    We used agnostic, unsupervised machine learning to cluster a large clinical database of information on infants admitted to neonatal units in England. Our aim was to obtain insights into nutritional practice, an area of central importance in newborn care, utilising the UK National Neonatal Research Database (NNRD). We performed clustering on time-series data of daily nutritional intakes for very preterm infants born at a gestational age less than 32 weeks (n = 45,679) over a six-year period. This revealed 46 nutritional clusters heterogeneous in size, showing common interpretable clinical practices alongside rarer approaches. Nutritional clusters with similar admission profiles revealed associations between nutritional practice, geographical location and outcomes. We show how nutritional subgroups may be regarded as distinct interventions and tested for associations with measurable outcomes. We illustrate the potential for identifying relationships between nutritional practice and outcomes with two examples, discharge weight and bronchopulmonary dysplasia (BPD). We identify the well-known effect of formula milk on greater discharge weight as well as support for the plausible, but insufficiently evidenced view that human milk is protective against BPD. Our framework highlights the potential of agnostic machine learning approaches to deliver clinical practice insights and generate hypotheses using routine data.

  • Report
    Ougham K, Modi N, 2021,

    NDAU 2017 Report

    , NDAU 2017 Report, London, UK, Publisher: Neonatal Data Analysis Unit, Imperial College London, 6

    Neonatal Data Analysis Unit report 2017

  • Journal article
    Gale C, Quigley MA, Placzek A, Knight M, Ladhani S, Draper ES, Sharkey D, Doherty C, Mactier H, Kurinczuk JJet al., 2021,

    The ability of the neonatal immune response to handle SARS-CoV-2 infection - Authors' reply

    , The Lancet Child and Adolescent Health, Vol: 5, Pages: e8-e8, ISSN: 2352-4642
  • Journal article
    Duhig KE, Myers JE, Gale C, Girling JC, Harding K, Sharp A, simpson NAB, Tuffnell D, Seed PT, Shennan AH, Chappell LCet al., 2021,

    Placental growth factor measurements in the assessment of women with suspected preeclampsia: a stratified analysis of the PARROT trial

    , Pregnancy Hypertension, Vol: 23, Pages: 41-47, ISSN: 2210-7789

    ObjectivePlacental growth factor testing decreases time to recognition of preeclampsia and may reduce severe maternal adverse outcomes. This analysis aims to describe the clinical phenotype of women by PlGF concentration, and to determine the mechanism(s) underpinning the reduction in severe maternal adverse outcomes in the PARROT trial, in order to inform how PlGF testing may be optimally used within clinical management algorithms.Study designThis was a planned secondary analysis from the PARROT trial that compared revealed PlGF testing and management guidance with usual care in the assessment of women with suspected preterm preeclampsia.Main outcome measuresMaternal and perinatal outcomes following stratification of women by trial group, and measured PlGF concentration.Results1006 women were included. PlGF < 100 pg/ml identified women with more marked hypertension, increased adverse maternal outcomes and preterm delivery rates, and higher rates of small for gestational age infants. There was a reduction in adverse maternal outcomes in women whose results were revealed when PlGF levels were 12–100 pg/ml compared to usual care (3.8% vs 6.9%; aOR 0.15(95% CI 0.03–0.92). There was no significant difference in gestation at delivery between concealed or revealed groups in any PlGF categories.ConclusionLow PlGF concentrations are associated with severe preeclampsia. The reduction in severe adverse maternal outcomes may be mediated through quicker diagnosis and intensive surveillance, as recommended by the management algorithm for those at increased risk. PlGF is particularly beneficial in those who test 12–100 pg/ml, as these may be women with silent multi-organ disease who otherwise may go undetected.

  • Journal article
    Nimish S, Jawad S, Ougham K, Gale C, Battersby Cet al., 2021,

    Increasing use of inhaled nitric oxide in neonatal intensive care units in England: a retrospective population study

    , BMJ Paediatrics Open, Vol: 5, ISSN: 2399-9772

    Objective To describe temporal changes in inhaled nitric oxide (iNO) use in English neonatal units between 2010 and 2015.Design Retrospective analysis using data extracted from the National Neonatal Research Database.Setting All National Health Service neonatal units in England.Patients Infants of all gestational ages born 2010–2015 admitted to a neonatal unit and received intensive care.Main outcome measures Proportion of infants who received iNO; age at initiation and duration of iNO use.Results 4.9% (6346/129 883) of infants received iNO; 31% (1959/6346) were born <29 weeks, 18% (1152/6346) 29–33 weeks and 51% (3235/6346)>34 weeks of gestation. Between epoch 1 (2010–2011) and epoch 3 (2014–2015), there was (1) an increase in the proportion of infants receiving iNO: <29 weeks (4.9% vs 15.9%); 29–33 weeks (1.1% vs 4.8%); >34 weeks (4.5% vs 5.0%), (2) increase in postnatal age at iNO initiation: <29 weeks 10 days vs 18 days; 29–33 weeks 2 days vs 10 days, (iii) reduction in iNO duration: <29 weeks (3 days vs 2 days); 29–33 weeks (2 days vs 1 day).Conclusions Between 2010 and 2015, there was an increase in the use of iNO among infants admitted to English neonatal units. This was most notable among the most premature infants with an almost fourfold increase. Given the cost of iNO therapy, limited evidence of efficacy in preterm infants and potential for harm, we suggest that exposure to iNO should be limited, ideally to infants included in research studies (either observational or randomised placebo-controlled trial) or within a protocolised pathway. Development of consensus guidelines may also help standardise practice.

  • Journal article
    Deja E, Roper L, Tume L, Dorling J, Gale C, Arch B, Latten L, Pathan N, Eccleson H, Hickey H, Preston J, Beissel A, Andrzejewska I, Valla F, Woolfall Ket al., 2021,

    Can they stomach it? Parent and practitioner acceptability of a trial comparing Gastric Residual Volume measurement versus no Gastric Residual Volume in UK NNU and PICU’s: a feasibility study

    , Pilot and Feasibility Studies, Vol: 7, ISSN: 2055-5784

    BackgroundRoutine measurement of gastric residual volume (GRV) to guide feeding in neonatal and paediatric intensive care is widespread. However, this practice is not evidence based and may cause harm. As part of a feasibility study, we explored parent and practitioner views on the acceptability of a trial comparing GRV measurement or no GRV measurement.MethodsA mixed-methods study involving interviews and focus groups with practitioners and interviews with parents with experience of tube feeding in neonatal and/or paediatric intensive care. A voting system recorded closed question responses during practitioner data collection, enabling the collection of quantitative and qualitative data. Data were analysed using thematic analysis and descriptive statistics.ResultsWe interviewed 31 parents and nine practitioners and ran five practitioner focus groups (n=42). Participants described how the research question was logical, and the intervention would not be invasive and potential benefits of not withholding the child’s feeds. However, both groups held concerns about the potential risk of not measuring GRV, including delayed diagnosis of infection and gut problems, increased risk of vomiting into lungs and causing discomfort or pain. Parent’s views on GRV measurement and consent decision making were influenced by their views on the importance of feeding in the ICU, their child’s prognosis and associated comorbidities or complications.ConclusionsThe majority of parents and practitioners viewed the proposed trial as acceptable. Potential concerns and preferences were identified that will need careful consideration to inform the development of the proposed trial protocol and staff training.

  • Journal article
    Vasu V, Gale C, 2021,

    Understanding the impact of size at birth and prematurity on biological ageing: the utility and pitfalls of a life-course approach

    , Pediatric Research, Vol: 89, Pages: 411-412, ISSN: 0031-3998
  • Journal article
    Modi N, 2021,

    Facilitating quality improvement through routinely recorded clinical information

    , SEMINARS IN FETAL & NEONATAL MEDICINE, Vol: 26, ISSN: 1744-165X

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