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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
    McLeish J, Alderdice F, Robberts H, Cole C, Dorling J, Gale Cet al., 2021,

    Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: a qualitative study of parents’ and health professionals’ views and experiences

    , Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 106, Pages: 244-250, ISSN: 1359-2998

    Background: More effective recruitment strategies like alternative approaches to consent are needed to facilitate adequately powered trials. WithHolding Enteral feeds Around Transfusion (WHEAT) was a multicentre, randomised, pilot trial that compared withholding and continuing feeds around transfusion. The primary clinical outcome was necrotising enterocolitis (NEC). The trial used simplified opt-out consent with concise parent information and no consent form.Objective: To explore the views and experiences of parents and health professionals on the acceptability and feasibility of opt-out consent in randomised comparative effectiveness trials.Methods: A qualitative, descriptive interview-based study nested within a randomised trial. Semi-structured interview transcripts were analysed using inductive thematic analysis.Setting: Eleven neonatal units in England.Participants: Eleven parents and ten health professionals with experience of simplified consent. Results: Five themes emerged: ‘Opt-out consent operationalised as verbal opt-in consent’, ‘Opt-out consent normalises participation while preserving parental choice’, ‘Opt-out consent as an ongoing process of informed choice’, ‘Consent without a consent form’ and ‘Choosing to opt out of a comparative effectiveness trial’, with two subthemes: ‘Wanting “normal care”’ and ‘A belief that feeding is better’. Conclusions: Introducing a novel form of consent proved challenging in practice. The principle of simplified, opt-out approach to consent was generally considered feasible and acceptable by health professionals for a neonatal comparative effectiveness trial. The priority for parents was having the right to decide about trial participation, and they did not see opt-out consent as undermining this. Describing a study as ‘opt-out’ can help to normalise participation and emphasise that parents can withdraw consent.

  • 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
    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

  • 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
    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.

  • Journal article
    Ewer AK, Deshpande SA, Gale C, Stenson BJ, Upton M, Evans C, Oddie SJet al., 2020,

    Potential benefits and harms of universal newborn pulse oximetry screening: response to the UK National Screening Committee public consultation

    , ARCHIVES OF DISEASE IN CHILDHOOD, Vol: 105, Pages: 1128-+, ISSN: 0003-9888
  • Journal article
    Rees P, Stilwell PA, Bolton C, Akillioglu M, Carter B, Gale C, Sutcliffe Aet al., 2020,

    Childhood health and educational outcomes after neonatal abstinence syndrome: a systematic review and meta-analysis.

    , The Journal of Pediatrics, Vol: 226, Pages: 149-156.e16, ISSN: 0022-3476

    OBJECTIVE: To systematically review and meta-analyze the association between neonatal abstinence syndrome (NAS) and adverse health or educational childhood outcomes. STUDY DESIGN: An all-language search was conducted across 11 databases between 1/1/75, and 9/3/19, and 5865 titles were identified. Observational studies of children between 28 days and 16 years of age, in whom a diagnosis of NAS was documented, were included. Outcomes included reasons for hospital admissions, childhood diagnoses, developmental outcomes, and academic attainment scores. All studies underwent independent review by two trained reviewers, who extracted study data and assessed risk of bias using the Newcastle Ottawa Tool. RESULTS: Fifteen studies were included comprising 10,907 children with previous NAS and 1,730,213 children without previous NAS, aged 0-16 years. There was a strong association between NAS and subsequent child maltreatment (aOR 6.49 (4.46, 9.45, I2=52%)), injuries and poisoning (aOR 1.34 (1.21, 1.49, I2= 0%)), and a variety of mental health conditions. Studies consistently demonstrated an increased incidence of strabismus and nystagmus among those with previous NAS. Children with NAS also had lower mean academic scores than the control group in every domain of testing across age groups. CONCLUSIONS: NAS is significantly associated with future child maltreatment, mental health diagnoses, visual problems and poor school performance. Due to the necessary inclusion of non-randomized studies, incomplete reporting among studies and likely unadjusted confounding, this review does not suggest causation. However, we highlight associations requiring further investigation and targeted intervention, to positively impact the life course trajectories of this growing population of children.

  • Journal article
    Yeo KT, Oei JL, De Luca D, Schmölzer GM, Guaran R, Palasanthiran P, Kumar K, Buonocore G, Cheong J, Owen LS, Kusuda S, James J, Lim G, Sharma A, Uthaya S, Gale C, Whittaker E, Battersby C, Modi N, Norman M, Naver L, Giannoni E, Diambomba Y, Shah PS, Gagliardi L, Harrison M, Pillay S, Alburaey A, Yuan Y, Zhang H, Yeo KT, Oei JL, De Luca D, Schmolzer GM, Guaran R, Plasanthiran P, Kumar K, Buonocore G, Cheong J, Owen LS, Kusuda S, James J, Lim G, Sharma A, Uthaya S, Gale C, Whittaker E, Battersby C, Modi N, Norman M, Naver L, Giannoni E, Diambomba Y, Shah PS, Gagliardi L, Harrison M, Pilay S, Alburaey A, Yuan Y, Zhang Het al., 2020,

    Review of guidelines and recommendations from 17 countries highlights the challenges that clinicians face caring for neonates born to mothers with COVID-19.

    , Acta Paediatrica: Nurturing the Child, Vol: 109, Pages: 2192-2207, ISSN: 1651-2227

    AIM: This review examined how applicable national and regional clinical practice guidelines and recommendations for managing neonates born to mothers with COVID-19 mothers were to the evolving pandemic. METHODS: A systematic search and review identified 20 guidelines and recommendations that had been published by 25 May 2020. We analysed documents from 17 countries: Australia, Brazil, Canada, China, France, India, Italy, Japan, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, the UK and the USA. RESULTS: The documents were based on expert consensus with limited evidence and were of variable, low methodological rigour. Most did not provide recommendations for delivery methods or managing symptomatic infants. None provided recommendations for post-discharge assimilation of potentially-infected infants into the community. The majority encouraged keeping mothers and infants together, subject to infection control measures, but one-third recommended separation. Although breastfeeding or using breastmilk were widely encouraged, two countries specifically prohibited this. CONCLUSION: The guidelines and recommendations for managing infants affected by COVID-19 were of low, variable quality and may be unsustainable. It is important that transmission risks are not increased when new information is incorporated into clinical recommendations. Practice guidelines should emphasise the extent of uncertainty and clearly define gaps in the evidence.

  • Journal article
    Prior E, Modi N, 2020,

    Adult outcomes after preterm birth

    , POSTGRADUATE MEDICAL JOURNAL, Vol: 96, Pages: 619-622, ISSN: 0032-5473

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