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

    Characteristics and outcomes of neonatal SARS-CoV-2 infection in the United Kingdom: a prospective national cohort study using active surveillance

    , The Lancet Child and Adolescent Health, Vol: 5, Pages: 113-121, ISSN: 2352-4642

    Background: Babies differ in their exposure to SARS-CoV-2relative to older children. There are limited data describing the impact of SARS-CoV-2 in this group and guidance is variable. Methods: ProspectiveUKpopulation-based cohort study of babies with confirmed SARS-CoV-2 infection in the first28 days that received inpatient care, 1st March 2020to30thApril 2020. Babies were identified through active national surveillance with linkage to national testing, paediatric intensive care audit and obstetric surveillance data. Outcomes included incidence per10,000 live births of inpatient hospital care with confirmed SARS-CoV-2 infection, severe disease, suspected vertically and nosocomially acquired infection. Findings: Sixty-six babies had SARS-CoV-2 infection and received inpatient care, an incidence of 5·6(95% CI 4·3, 7·1); 28 (42%) babies had severe neonatal SARS-CoV-2 infection, incidence 2·4 (95% CI 1·6, 3·4). Twenty-nine babies (45%) were from black, Asian or minority ethnic groups, an incidence of 11·1(95% CI 7·4, 15·9); incidence in white group 4·6(95% CI 3·2, 6·4). Sixteen(24%) babies were born preterm. Seventeen(26%) babies with confirmed infection were born to mothers with known perinatal SARS-CoV-2 infection. Two babies had possible vertically acquired infection and eight (12%) babies had suspected no socomial infection. Most babies (58, 88%) have been discharged home; one baby died of a cause unrelated to SARS-CoV-2 infection.Interpretation: Inpatient care in babies with neonatal SARS-CoV-2 infection is uncommon.Babies in hospital with SARS-CoV-2 infection were more likely to have severe disease than older children, although outcomes were good. Infection with neonatal admission following birth to a mother with perinatal SARS-CoV-2 infection was unlikely and possible vertical transmission rare, supporting international guidance to avoid separation of mother and baby. The high pro

  • Report
    Gale C, statnikov E, Jawad S, Uthaya S, Modi Net al., 2021,

    Correction to: Brain injury occurring during or soon after birth: a report for the national maternity ambition commissioned by the Department of Health

    , Correction to: Brain injury occurring during or soon after birth: a report for the national maternity ambition commissioned by the Department of Health, London, UK, Publisher: The Neonatal Data Analysis Unit, Imperial College London, 1
  • Report
    Gale C, Ougham K, Jawad S, Uthaya S, Modi Net al., 2021,

    Brain injury occurring during or soon after birth: annual incidence and rates of brain injuries to monitor progress against the national maternity ambition 2018 and 2019 national data

    , Brain injury occurring during or soon after birth: annual incidence and rates of brain injuries to monitor progress against the national maternity ambition 2018 and 2019 national data, London, UK, Publisher: The Neonatal Data Analysis Unit, Imperial College London, 3
  • Report
    Gale C, Jeyakumaran D, Ougham K, Jawad S, Uthaya S, Modi Net al., 2021,

    Correction to: Brain injury occurring during or soon afterbirth: annual incidence and rates of brain injuries to monitorprogress against the national maternity ambition. 2016 and 2017 data

    , Correction to: Brain injury occurring during or soon afterbirth: annual incidence and rates of brain injuries to monitorprogress against the national maternity ambition. 2016 and 2017 data, London, UK, Publisher: The Neonatal Data Analysis Unit, Imperial College London, 2

    Correction to the following report: https://doi.org/10.25561/87336

  • Journal article
    Milton R, Sanders J, Barlow C, Brocklehurst P, Cannings-John R, Channon S, Gale C, Holmes A, Hunter B, Paranjothy S, Lugg-Widger F, Milosevic S, Morantz L, Plachcinski R, Nolan M, Robling Met al., 2021,

    Establishing the safety of waterbirth for mothers and babies: a cohort study with nested qualitative component: the protocol for the POOL study

    , BMJ Open, Vol: 11, Pages: 1-9, ISSN: 2044-6055

    Introduction Approximately 60 000 (9/100) infants are born into water annually in the UK and this is likely to increase. Case reports identified infants with water inhalation or sepsis following birth in water and there is a concern that women giving birth in water may sustain more complex perineal trauma. There have not been studies large enough to show whether waterbirth increases these poor outcomes. The POOL Study (ISRCTN13315580) plans to answer the question about the safety of waterbirths among women who are classified appropriate for midwifery-led intrapartum care.Methods and analysis A cohort study with a nested qualitative component. Objectives will be answered using retrospective and prospective data captured in electronic National Health Service (NHS) maternity and neonatal systems. The qualitative component aims to explore factors influencing pool use and waterbirth; data will be gathered via discussion groups, interviews and case studies of maternity units.Ethics and dissemination The protocol has been approved by NHS Wales Research Ethics Committee (18/WA/0291) the transfer of identifiable data has been approved by Health Research Authority Confidentiality Advisory Group (18CAG0153).Study findings and innovative methodology will be disseminated through peer-reviewed journals, conferences and events. Results will be of interest to the general public, clinical and policy stakeholders in the UK and will be disseminated accordingly.

  • Journal article
    Tume L, Arch B, Woolfall K, Roper L, Deja E, Jones A, Latten L, Eccleston H, Nazima P, Preston J, Beissel A, Andrzejewska I, Gale C, Valla F, Dorling Jet al., 2021,

    Determining optimal outcome measures in a trial investigating no routine gastric residual volume measurement in critically ill children

    , Journal of Parenteral and Enteral Nutrition, Vol: 45, Pages: 79-86, ISSN: 0148-6071

    BackgroundChoosing trial outcome measures is important. When outcomes are not clinically relevant or important to parents/patients, trial evidence is less likely to be implemented into practice. This study aimed to determine optimal outcome measures for a trial of no routine gastric residual volume (GRV) measurement in critically ill children.MethodsA mixed‐methods approach was used: a focused literature review, parent and clinician interviews, a modified 2‐round Delphi, and a stakeholder consensus meeting.ResultsThe review generated 13 outcomes. Fourteen pediatric intensive care unit (PICU) parents proposed 3 additional outcomes; these 16 were then rated by 28 clinicians in Delphi round 1. Six further outcomes were proposed, and 22 outcomes were rated in the second round. No items were voted “consensus out.” The 18 “no‐consensus” items were voted in a face‐to‐face meeting by 30 participants. The final 12 outcome measures were time to reach energy targets, ventilator‐associated pneumonia, vomiting, time enteral feeds withheld per 24 hours, necrotizing enterocolitis, length of invasive ventilation, PICU length of stay, mortality, change in weight and markers of feed intolerance (parenteral nutrition administered), feed formula altered, and change to postpyloric feeds all secondary to feed intolerance.ConclusionWe have identified 12 outcomes for a trial of no GRV measurement through a multistage process, seeking views of parents and clinicians.

  • Journal article
    Gagliardi L, Rusconi F, Reichman B, Adams M, Modi N, Lehtonen L, Kusuda S, Vento M, Darlow BA, Bassler D, Isayama T, Norman M, Håkansson S, Lee SK, Lui K, Yang J, Shah P, International Network for Evaluating Outcomes of Neonates iNeo Investigatorset al., 2021,

    Neonatal outcomes of extremely preterm twins by sex pairing: an international cohort study.

    , Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 106, Pages: 17-24, ISSN: 1359-2998

    OBJECTIVE: Infant boys have worse outcomes than girls. In twins, the 'male disadvantage' has been reported to extend to female co-twins via a 'masculinising' effect. We studied the association between sex pairing and neonatal outcomes in extremely preterm twins. DESIGN: Retrospective cohort study SETTING: Eleven countries participating in the International Network for Evaluating Outcomes of Neonates. PATIENTS: Liveborn twins admitted at 23-29 weeks' gestation in 2007-2015. MAIN OUTCOME MEASURES: We examined in-hospital mortality, grades 3/4 intraventricular haemorrhage or cystic periventricular leukomalacia (IVH/PVL), bronchopulmonary dysplasia (BPD), retinopathy of prematurity requiring treatment and a composite outcome (mortality or any of the outcomes above). RESULTS: Among 20 924 twins, 38% were from male-male pairs, 32% were from female-female pairs and 30% were sex discordant. We had no information on chorionicity. Girls with a male co-twin had lower odds of mortality, IVH/PVL and the composite outcome than girl-girl pairs (reference group): adjusted OR (aOR) (95% CI) 0.79 (0.68 to 0.92), 0.83 (0.72 to 0.96) and 0.88 (0.79 to 0.98), respectively. Boys with a female co-twin also had lower odds of mortality: aOR 0.86 (0.74 to 0.99). Boys from male-male pairs had highest odds of BPD and composite outcome: aOR 1.38 (1.24 to 1.52) and 1.27 (1.16 to 1.39), respectively. CONCLUSIONS: Sex-related disparities in outcomes exist in extremely preterm twins, with girls having lower risks than boys and opposite-sex pairs having lower risks than same-sex pairs. Our results may help clinicians in assessing risk in this large segment of extremely preterm infants.

  • Journal article
    Modi N, 2021,

    Future Research in Preterm Nutrition

    , NUTRITIONAL CARE OF PRETERM INFANTS: SCIENTIFIC BASIS AND PRACTICAL GUIDELINES, 2ND EDITION, Vol: 122, Pages: 357-366, ISSN: 0084-2230
  • Journal article
    Goss KCW, Gale C, Malone R, Longford N, Ratcliffe K, Modi Net al., 2020,

    Effect of surfactant dose on outcomes in preterm infants with respiratory distress syndrome: the OPTI-SURF study protocol

    , BMJ Open, Vol: 10, Pages: 1-4, ISSN: 2044-6055

    Introduction Respiratory distress syndrome is a condition seen in preterm infants primarily due to surfactant insufficiency. European guidelines recommend the dose and method of surfactant administration. However, in routine practice, clinicians often use a ‘whole vial’ approach to surfactant dosing. The aim of this study is to assess whether in preterm infants of gestational age 36+6 weeks+days or less, a low first dose of surfactant (100–130 mg/kg) compared with a high first dose (170–200 mg/kg) affects survival with no mechanical ventilation on either on postnatal days 3 and 4, and other outcomes.Methods and analysis In this prospective, observational study, we will use the National Neonatal Research Database as the main data source. We will obtain additional information describing the dose and method of surfactant administration through the neonatal EPR system. We will use propensity scores to form matched groups with low first dose and high first dose for comparison.Ethics and dissemination This study was approved by the West Midlands—Black Country Research Ethics Committee (REC reference: 18/WM/0132; IRAS project ID: 237111). The results of the research will be made publicly available through presentations at local, national or international conferences and will be submitted for publication in a peer-reviewed journal.Trial registration number NCT03808402; Pre-results.

  • Journal article
    Bogiatzopoulou A, Mayberry H, Hawcutt DB, Whittaker E, Munro A, Roland D, Simba J, Gale C, Felsenstein S, Abrams E, Jones CB, Lewins I, Rodriguez-Martinez CR, Fernandes RM, Stilwell PA, Swann O, Bhopal S, Sinha I, Harwood Ret al., 2020,

    COVID-19 in children: what did we learn from the first wave?

    , Paediatrics and Child Health, Vol: 30, Pages: 438-443, ISSN: 1751-7222

    A pandemic caused by the novel coronavirus, severe acute respiratory syndrome - coronavirus 2 (SARS-CoV-2), has caused high rates of mortality, predominantly in adults. Children are significantly less affected by SARS-CoV-2 with far lower rates of recorded infections in children compared to adults, milder symptoms in the majority of children and very low mortality rates. A suspected late manifestation of the disease, paediatric inflammatory multisystem syndrome - temporally associated with SARS-CoV-2 (PIMS-TS), has been seen in small numbers of children and has a more severe disease course than acute SARS-CoV-2. The pandemic has meant that children around the world have been kept off school, isolated from their extended family and friends and asked to stay inside. The UK has just been declared as being in an economic recession and unemployment rates are increasing. These indirect effects of SARS-CoV-2 are likely to have a significant impact on many children for years to come. Consolidating the knowledge that has accumulated during the first wave of this pandemic is essential for recognising the clinical signs, symptoms and effective treatment strategies for children; identifying children who may be at increased risk of severe SARS-CoV-2 infection; planning the safe delivery of healthcare and non-health related services that are important for childrens’ wellbeing; and engaging in, and developing, research to address the things that are not yet known. This article summarises the evidence that has emerged from the early phase of the pandemic and offers an overview for those looking after children or planning services.

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