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  • 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
    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
    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
    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
    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
    Modi N, Hanson M, 2020,

    Maternal, neonatal, and child health is essential for meeting SDG 3.4

    , LANCET, Vol: 396, Pages: 1731-1732, ISSN: 0140-6736
  • Journal article
    Jacob CM, Briana DD, Di Renzo GC, Modi N, Bustreo F, Conti G, Malamitsi-Puchner A, Hanson Met al., 2020,

    Building resilient societies after COVID-19: the case for investing in maternal, neonatal, and child health

    , LANCET PUBLIC HEALTH, Vol: 5, Pages: E624-E627, ISSN: 2468-2667
  • 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

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