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  • Journal article
    Klerk DHH, van Varsseveld OCC, Offringa M, Modi N, Lacher M, Zani A, Pakarinen MPP, Koivusalo A, Jester I, Spruce M, Derikx JPM, Bakx R, Ksia A, Vermeulen MJJ, Kooi EMW, Hulscher JBFet al., 2023,

    Development of an international core outcome set for treatment trials in necrotizing enterocolitis-a study protocol

    , TRIALS, Vol: 24
  • Journal article
    Gong J, Fellmeth G, Quigley MA, Gale C, Stein A, Alderdice F, Harrison Set al., 2023,

    Prevalence and risk factors for postnatal mental health problems in mothers of infants admitted to neonatal care: Analysis of two population-based surveys in England

    , BMC Pregnancy and Childbirth, Vol: 23, Pages: 1-16, ISSN: 1471-2393

    BackgroundPrevious research suggests that mothers whose infants are admitted to neonatal units (NNU) experience higher rates of mental health problems compared to the general perinatal population. This study examined the prevalence and factors associated with postnatal depression, anxiety, post-traumatic stress (PTS), and comorbidity of these mental health problems for mothers of infants admitted to NNU, six months after childbirth.MethodsThis was a secondary analysis of two cross-sectional, population-based National Maternity Surveys in England in 2018 and 2020. Postnatal depression, anxiety, and PTS were assessed using standardised measures. Associations between sociodemographic, pregnancy- and birth-related factors and postnatal depression, anxiety, PTS, and comorbidity of these mental health problems were explored using modified Poisson regression and multinomial logistic regression.ResultsEight thousand five hundred thirty-nine women were included in the analysis, of whom 935 were mothers of infants admitted to NNU. Prevalence of postnatal mental health problems among mothers of infants admitted to NNU was 23.7% (95%CI: 20.6–27.2) for depression, 16.0% (95%CI: 13.4–19.0) for anxiety, 14.6% (95%CI: 12.2–17.5) for PTS, 8.2% (95%CI: 6.5–10.3) for two comorbid mental health problems, and 7.5% (95%CI: 5.7–10.0) for three comorbid mental health problems six months after giving birth. These rates were consistently higher compared to mothers whose infants were not admitted to NNU (19.3% (95%CI: 18.3–20.4) for depression, 14.0% (95%CI: 13.1–15.0) for anxiety, 10.3% (95%CI: 9.5–11.1) for PTS, 8.5% (95%CI: 7.8–9.3) for two comorbid mental health problems, and 4.2% (95%CI: 3.6–4.8) for three comorbid mental health problems six months after giving birth. Among mothers of infants admitted to NNU (N = 935), the strongest risk factors for mental health problems were having a long-term mental health probl

  • Journal article
    Webbe J, Allin B, Knight M, Modi N, Gale Cet al., 2023,

    How to reach agreement: the impact of different analytical approaches to Delphi process results in core outcomes set development

    , Trials, Vol: 24, ISSN: 1745-6215

    Background: Core outcomes sets are increasingly used to define research outcomes that are most important for a condition. Different consensus methods are used in the development of core outcomes sets; the most common is the Delphi process. Delphi methodology is increasingly standardised for core outcomes set development, butuncertainties remain. We aimed to empirically test how the use of different summary statistics and consensus criteria impact Delphi process results.Methods: Results from two unrelated child health Delphi processes were analysed. Outcomes were ranked by mean, median, or rate of exceedance, and then pairwisecomparisons were undertaken to analyse whether the rankings were similar. The correlation coefficient for each comparison was calculated, and Bland-Altman plotsproduced. Youden’s index was used to assess how well the outcomes ranked highest by each summary statistic matched the final core outcomes sets. Consensus criteria identified in a review of published Delphi processes were applied to the results of the two child-health Delphi processes. The size of the consensus setsproduced by different criteria was compared, and Youden’s index was used to assess how well the outcomes that met different criteria matched the final core outcomes sets.Results: Pairwise comparisons of different summary statistics produced similar correlation coefficients. Bland-Altman plots showed that comparisons involving ranked medians had wider variation in the ranking. No difference in Youden’s index for the summary statistics was found.Different consensus criteria produced widely different sets of consensus outcomes (Range: 5-44 included outcomes). They also showed differing abilities to identify core outcomes (Youden’s index Range: 0.32-0.92). The choice of consensus criteria had a large impact on Delphi results.Discussion: The use of different summary statistics is unlikely to affect how outcomes are ranked during a Delphi process: mean, media

  • Journal article
    Yuill C, Harkness M, Wallace C, Cheyne H, Black M, Modi N, Pasupathy D, Sanders J, Stock SJ, McCourt Cet al., 2023,

    Clinicians' perspectives and experiences of providing cervical ripening at home or in-hospital in the United Kingdom

    , PLOS ONE, Vol: 18, ISSN: 1932-6203
  • Journal article
    Molloy EJ, Nakra N, Gale C, Dimitriades VR, Lakshminrusimha Set al., 2023,

    Multisystem inflammatory syndrome in children (MIS-C) and neonates (MIS-N) associated with COVID-19: optimizing definition and management

    , Pediatric Research, Vol: 93, Pages: 1499-1508, ISSN: 0031-3998

    During the SARS-CoV-2-associated infection (COVID-19), pandemic initial reports suggested relative sparing of children inversely related to their age. Children and neonates have a decreased incidence of SARS-CoV-2 infection, and if infected they manifested a less severe phenotype, in part due to enhanced innate immune response. However, a multisystem inflammatory syndrome in children (MIS-C) or paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 emerged involving coronary artery aneurysms, cardiac dysfunction, and multiorgan inflammatory manifestations. MIS-C has many similarities to Kawasaki disease and other inflammatory conditions and may fit within a spectrum of inflammatory conditions based on immunological results. More recently neonates born to mothers with SARS-CoV-2 infection during pregnancy demonstrated evidence of a multisystem inflammatory syndrome with raised inflammatory markers and multiorgan, especially cardiac dysfunction that has been described as multisystem inflammatory syndrome in neonates (MIS-N). However, there is a variation in definitions and management algorithms for MIS-C and MIS-N. Further understanding of baseline immunological responses to allow stratification of patient groups and accurate diagnosis will aid prognostication, and inform optimal immunomodulatory therapies. IMPACT: Multisystem inflammatory system in children and neonates (MIS-C and MIS-N) post COVID require an internationally recognized consensus definition and international datasets to improve management and plan future clinical trials. This review incorporates the latest review of pathophysiology, clinical information, and management of MIS-C and MIS-N. Further understanding of the pathophysiology of MIS-C and MIS-N will allow future targeted therapies to prevent and limit clinical sequelae.

  • Journal article
    Yang M, Campbell H, Pillay T, Boyle EM, Modi N, Rivero-Arias Oet al., 2023,

    Neonatal health care costs of very preterm babies in England: a retrospective analysis of a national birth cohort

    , BMJ PAEDIATRICS OPEN, Vol: 7
  • Journal article
    Hayes R, Hartnett J, Semova G, Murray C, Murphy K, Carroll L, Plapp H, Hession L, O'Toole J, McCollum D, Roche E, Jenkins E, Mockler D, Hurley T, McGovern M, Allen J, Meehan J, Plotz FB, Strunk T, de Boode WP, Polin R, Wynn JL, Degtyareva M, Kuester H, Janota J, Giannoni E, Schlapbach LJ, Keij FM, Reiss IKM, Bliss J, Koenig JM, Turner MA, Gale C, Molloy EJet al., 2023,

    Neonatal sepsis definitions from randomised clinical trials

    , Pediatric Research, Vol: 93, Pages: 1141-1148, ISSN: 0031-3998

    Introduction:Neonatal sepsis is a leading cause of infant mortality worldwide with non-specific and varied presentation. We aimed to catalogue the current definitions of neonatal sepsis in published randomised controlled trials (RCTs).Method:A systematic search of the Embase and Cochrane databases was performed for RCTs which explicitly stated a definition for neonatal sepsis. Definitions were sub-divided into five primary criteria for infection (culture, laboratory findings, clinical signs, radiological evidence and risk factors) and stratified by qualifiers (early/late-onset and likelihood of sepsis).Results:Of 668 papers screened, 80 RCTs were included and 128 individual definitions identified. The single most common definition was neonatal sepsis defined by blood culture alone (n = 35), followed by culture and clinical signs (n = 29), and then laboratory tests/clinical signs (n = 25). Blood culture featured in 83 definitions, laboratory testing featured in 48 definitions while clinical signs and radiology featured in 80 and 8 definitions, respectively.Discussion:A diverse range of definitions of neonatal sepsis are used and based on microbiological culture, laboratory tests and clinical signs in contrast to adult and paediatric sepsis which use organ dysfunction. An international consensus-based definition of neonatal sepsis could allow meta-analysis and translate results to improve outcomes.

  • Journal article
    Meka K, Jacob CM, Modi N, Bustreo F, Di Renzo GC, Malamitsi-Puchner A, Briana D, Iaia DG, Fogstad H, Tamvada JP, Moreno IO, Hanson Met al., 2023,

    Valuing maternal, newborn, child and adolescent health for societal progress - Going beyond the economic orthodoxy of gross domestic product

    , ACTA PAEDIATRICA, Vol: 112, Pages: 630-634, ISSN: 0803-5253
  • Journal article
    Moss B, Lammons W, Geiger I, Koestenzer J, Mader S, Coutinho E, Kamphuis J, Soiron S, Bergmuller E, Modi Net al., 2023,

    A pressing need for research to reduce nutritional uncertainties in preterm infant care: Findings from a European roundtable discussion with parent representatives

    , EARLY HUMAN DEVELOPMENT, Vol: 179, ISSN: 0378-3782
  • Journal article
    Sturrock S, Ali S, Gale C, Battersby C, Le Doare Ket al., 2023,

    Neonatal outcomes and indirect consequences following maternal SARS-CoV-2 infection in pregnancy: a systematic review

    , BMJ Open, Vol: 13, Pages: 1-8, ISSN: 2044-6055

    Objectives: Identify the association between maternal SARS-CoV-2 infection in pregnancy and individual neonatal morbidities and outcomes, particularly longer-term outcomes such as neurodevelopment.Design: Systematic review of outcomes of neonates born to pregnant women diagnosed with a SARS-CoV-2 infection at any stage during pregnancy, including asymptomatic women.Data sources: MEDLINE, Embase, Global Health, WHOLIS and LILACS databases, last searched 28th July 2021.Eligibility criteria: Case-control and cohort studies published after 1st January 2020, including pre-print articles were included. Study outcomes included neonatal mortality and morbidity, preterm birth, Caesarean delivery, small for gestational age, admission to neonatal intensive care unit, level of respiratory support required, diagnosis of culture-positive sepsis, evidence of brain injury, necrotising enterocolitis, visual or hearing impairment, neurodevelopmental outcomes, and feeding method. These were selected according to a Core Outcome Set.Data extraction and synthesis: Data were extracted into Microsoft Excel by 2 researchers, with statistical analysis completed using IBM SPSS. Risk of bias was assessed using a modified Newcastle-Ottawa scale.Results: The search returned 3234 papers, from which 204 were included with a total of 45,646 infants born to mothers with SARS-CoV-2 infection during pregnancy across 36 countries. We found limited evidence of an increased risk of some neonatal morbidities, including respiratory disease. There was minimal evidence from low-income settings (1 study) and for neonatal outcomes following first trimester infection (17 studies). Neonatal mortality was very rare. Preterm birth, neonatal unit admission and small for gestational age status were more common in infants born following maternal SARS-CoV-2 infection in pregnancy in most larger studies.Conclusions: There are limited data on neonatal morbidity and mortality following maternal SARS-CoV-2 infectio

This data is extracted from the Web of Science and reproduced under a licence from Thomson Reuters. You may not copy or re-distribute this data in whole or in part without the written consent of the Science business of Thomson Reuters.

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