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Objective: To describe clinical pathways for infants with congenital diaphragmatic hernia (CDH) and short-term outcomes., Design: Retrospective observational cohort study using the UK National Neonatal Research Database (NNRD)., Patients: Babies with a diagnosis of CDH admitted to a neonatal unit in England and Wales between 2012 and 2020., Main Outcome Measures: Clinical pathways defined by place of birth (with or without colocated neonatal and surgical facilities), transfers, clinical interventions, length of hospital stay and discharge outcome., Results: There were 1319 babies with a diagnosis of CDH cared for in four clinical pathways: born in maternity units with (1) colocated tertiary neonatal and surgical units (' neonatal surgical units '), 50% (660/1319); (2) designated tertiary neonatal unit and transfer to stand-alone surgical centre (' tertiary designated '), 25% (337/1319); (3) non-designated tertiary neonatal unit (' tertiary non-designated' ), 7% (89/1319); or (4) non-tertiary unit (' non-tertiary '), 18% (233/1319)-the latter three needing postnatal transfers. Infant characteristics were similar for infants born in neonatal surgical and tertiary designated units. Excluding 149 infants with minimal data due to early transfer (median (IQR) 2.2 (0.4-4.5) days) to other settings, survival to neonatal discharge was 73% (851/1170), with a median (IQR) stay of 26 (16-44) days., Conclusions: We found that half of the babies with CDH were born in hospitals that did not have on-site surgical services and required postnatal transfer. Similar characteristics between infants born in neonatal surgical units and tertiary designated units suggest that organisation rather than infant factors influence place of birth. Future work linking the NNRD to other datasets will enable comparisons between care pathways., Competing Interests: Competing interests: CB reports personal support from NIHR Advanced Fellowship; grants from National Institute for Health Research; personal fees to suport attendance at educational events from Chiesi Pharmaceuticals; she is deputy chair of the NIHR HTA Prioritisation commitee for hospital based care. CG reports personal support from the United Kingdom Medical Research Council Transition Support Fellowship during the conduct of the study; grants from National Institute for Health Research, Rosetrees Foundation, Canadian Institute for Health Research, Action Medical Research outside the submitted work; grants for research outside the submitted work and personal fees to support attendance at educational events from Chiesi Pharmaceuticals; he is chair of the NIHR Research for Patient Benefit London Regional Assessment Panel., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objective: The optimal time for neonatal stoma closure is unclear and there have been calls for a trial to compare early and late surgery. The feasibility of such a trial will depend on the population of eligible infants and acceptability to families and health professionals. In this study, we aimed to determine current UK practice and characteristics of those undergoing stoma surgery., Design: A retrospective cohort study of neonates who had undergone stoma surgery (excluding anorectal malformations and Hirschsprung's disease) using three national databases: the National Neonatal Research Database (NNRD, 2012-2019), British Association of Paediatric Surgeons Congenital Anomalies Surveillance System (BAPS-CASS, 2013-2014) and Hospital Episode Statistics-Admitted Patient Care (HES-APC, 2011-2018)., Results: 1830 eligible neonates were identified from NNRD, 163 from BAPS-CASS, 2477 from HES-APC. Median (IQR) duration of stoma in days was 57 (36-80) in NNRD, 63 (41-130) in BAPS-CASS and 78 (55-122) for neonates identified from HES-APC. At the time of closure, there were low rates of invasive ventilation (13%), inotrope use (5%) and recent steroids use (4%). Infants who underwent earlier closure (<9 weeks) were less preterm (median 28 weeks vs 25 weeks), have higher birth weight (median 986 g vs 764 g) and more likely to have stoma complications (29% vs 5%)., Conclusion: There are sufficient UK neonates undergoing stoma formation for a trial. Stoma closure is performed at around 2 months, with clinical stability, gestation, weight and stoma complications appearing to influence timing. The variation in practice we document indicates there is opportunity to optimise practice through a trial., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objective: Neonatal infection with wildtype SARS-CoV-2 is rare and good outcomes predominate. We investigated neonatal outcomes using national population-level data to describe the impact of different SARS-CoV-2 variants., Design: Prospective population-based cohort study., Setting: Neonatal, paediatric and paediatric intensive care inpatient care settings in the UK., Patients: Neonates (first 28 days after birth) with confirmed SARS-CoV-2 infection who received inpatient care, March 2020 to April 2022. Neonates were identified through active national surveillance with linkage to national SARS-CoV-2 testing data, routinely recorded neonatal data, paediatric intensive care data and obstetric and perinatal mortality surveillance data., Outcomes: Presenting signs, clinical course, severe disease requiring respiratory support are presented by the dominant SARS-CoV-2 variant in circulation at the time., Results: 344 neonates with SARS-CoV-2 infection received inpatient care; breakdown by dominant variant: 146 wildtype, 123 alpha, 57 delta and 18 omicron. Overall, 44.7% (153/342) neonates required respiratory support; short-term outcomes were good with 93.6% (322/344) of neonates discharged home. Eleven neonates died: seven unrelated to SARS-CoV-2 infection, four were attributed to neonatal SARS-CoV-2 infection (case fatality 4/344, 1.2% 95% CI 0.3% to 3.0%) of which three were born preterm due to maternal COVID-19. More neonates were born very preterm (23/54) and required invasive ventilation (27/57) when delta variant was predominant, and all four SARS-CoV-2-related deaths occurred in this period., Conclusions: Inpatient care for neonates with SARS-CoV-2 was uncommon. Although rare, severe neonatal illness was more common during the delta variant period, potentially reflecting more severe maternal disease and associated preterm birth., Trial Registration Number: ISRCTN60033461., Competing Interests: Competing interests: MK, MAQ, CG and JJK received grants from the UK NIHR Policy Research Programme in relation to the submitted work. KEF, AM, MH, AP, SNL, ESD, DS, CD and HM declare no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

ImportanceProphylactic cyclo-oxygenase inhibitors (COX-Is) such as indomethacin, ibuprofen and acetaminophen may prevent morbidity and mortality in extremely preterm infants (born ≤28 weeks' gestation). However, there is controversy around which COX-I, if any, is the most effective and safest, which has resulted in considerable variability in clinical practice.  Our objective was to develop rigorous and transparent clinical practice guideline recommendations for the prophylactic use of COX-I drugs for the prevention of mortality and morbidity in extremely preterm infants.  The Grading of Recommendations Assessment, Development and Evaluation evidence-to-decision framework for multiple comparisons was used to develop the guideline recommendations. A 12-member panel, including 5 experienced neonatal care providers, 2 methods experts, 1 pharmacist, 2 parents of former extremely preterm infants and 2 adults born extremely preterm, was convened. A rating of the most important clinical outcomes was established a priori. Evidence from a Cochrane network meta-analysis and a cross-sectional mixed-methods study exploring family values and preferences were used as the primary sources of evidence.  The panel recommended that prophylaxis with intravenous indomethacin may be considered in extremely preterm infants (conditional recommendation, moderate certainty in estimate of effects). Shared decision making with parents was encouraged to evaluate their values and preferences prior to therapy. The panel recommended against routine use of ibuprofen prophylaxis in this gestational age group (conditional recommendation, low certainty in the estimate of effects). The panel strongly recommended against use of prophylactic acetaminophen (strong recommendation, very low certainty in estimate of effects) until further research evidence is available., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Survival of babies born very preterm (<32 weeks gestational age) has increased, although preterm-born children may have ongoing morbidity. We aimed to investigate the risk of admission to paediatric intensive care units (PICUs) of children born very preterm following discharge home from neonatal care., Design: Retrospective cohort study, using data linkage of National Neonatal Research Database and the Paediatric Intensive Care Audit Network datasets., Setting: All neonatal units and PICUs in England and Wales., Patients: Children born very preterm between 1 January 2013 and 31 December 2018 and admitted to neonatal units., Main Outcome Measures: Admission to PICU after discharge home from neonatal care, before 2 years of age., Results: Of the 40 690 children discharged home from neonatal care, there were 2308 children (5.7%) with at least one admission to PICU after discharge. Of these children, there were 1901 whose first PICU admission after discharge was unplanned.The percentage of children with unplanned PICU admission varied by gestation, from 10.2% of children born <24 weeks to 3.3% born at 31 weeks.Following adjustment, unplanned PICU admission was associated with lower gestation, male sex (adjusted OR (aOR) 0.79), bronchopulmonary dysplasia (aOR 1.37), necrotising enterocolitis requiring surgery (aOR 1.39) and brain injury (aOR 1.42). For each week of increased gestation, the aOR was 0.90., Conclusions: Most babies born <32 weeks and discharged home from neonatal care do not require PICU admission in the first 2 years. The odds of unplanned admissions to PICU were greater in the most preterm and those with significant neonatal morbidity., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background: The provision of neonatal care is variable and commonly lacks adequate evidence base; strategic development of methodologically robust clinical trials is needed to improve outcomes and maximise research resources. Historically, neonatal research topics have been selected by researchers; prioritisation processes involving wider stakeholder groups have generally identified research themes rather than specific questions amenable to interventional trials., Objective: To involve stakeholders including parents, healthcare professionals and researchers to identify and prioritise research questions suitable for answering in neonatal interventional trials in the UK., Design: Research questions were submitted by stakeholders in population, intervention, comparison, outcome format through an online platform. Questions were reviewed by a representative steering group; duplicates and previously answered questions were removed. Eligible questions were entered into a three-round online Delphi survey for prioritisation by all stakeholder groups., Participants: One hundred and eight respondents submitted research questions for consideration; 144 participants completed round one of the Delphi survey, 106 completed all three rounds., Results: Two hundred and sixty-five research questions were submitted and after steering group review, 186 entered into the Delphi survey. The top five ranked research questions related to breast milk fortification, intact cord resuscitation, timing of surgical intervention in necrotising enterocolitis, therapeutic hypothermia for mild hypoxic ischaemic encephalopathy and non-invasive respiratory support., Conclusions: We have identified and prioritised research questions suitable for practice-changing interventional trials in neonatal medicine in the UK at the present time. Trials targeting these uncertainties have potential to reduce research waste and improve neonatal care., Competing Interests: Competing interests: CG is vice chair of the NIHR Research for Patient Benefit London Regional Advisory Panel and a member of the Glasgow Children’s Hospital Charity External Panel; he holds a Medical Research Council Transition Support Award. JPB is a member of the Wellcome Trust’s Career Development Award Panel and the Great Ormond Street Hospital Charity Research Assessment Panel. CB is the NIHR deputy chair of HTA prioritisation committee for hospitals. JD is a member of the NIHR HTA CET Funding Committee. CM is funded by HEE-NIHR Integrated Clinical Academic Programme and holds an NIHR ICA CSRF Fellowship. KE was supported by a Chelsea and Westminster NHS Foundation Trust Neonatal Clinical Research Fellow Programme., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Objective: Assessing parent experiences of neonatal services can help improve quality of care; however, there is no formally evaluated UK instrument available to assess this prospectively. Our objective was to refine an existing retrospective survey for 'real-time' feedback., Methods: Co-led by a parent representative, we recruited a convenience sample of parents of infants in a London tertiary neonatal unit. Our steering group selected questions from the existing retrospective 61-question Picker survey (2014), added and revised questions assessing communication and parent involvement. We established face validity, ensuring questions adequately captured the topic, conducted parent cognitive interviews to evaluate parental understanding of questions,and adapted the survey in three revision cycles. We evaluated survey performance., Results: The revised Parents' Experiences of Communication in Neonatal Care (PEC) survey contains 28 questions (10 new) focusing on communication and parent involvement. We cognitively interviewed six parents, and 67 parents completed 197 PEC surveys in the survey performance evaluation. Missing entries exceeded 5% for nine questions; we removed one and format-adjusted the rest as they had performed well during cognitive testing. There was strong inter-item correlation between two question pairs; however, all were retained as they individually assessed important concepts., Conclusion: Revised from the original 61-question Picker survey, the 28-question PEC survey is the first UK instrument formally evaluated to assess parent experience while infants are still receiving neonatal care. Developed with parents, it focuses on communication and parent involvement, enabling continuous assessment and iterative improvement of family-centred interventions in neonatal care., Competing Interests: Competing interests: SS received research grants from the National Institute of Health Research (NIHR), the NIHR CLAHRC NWL, Rosetrees Trust and CW+ charity. NM is director of the neonatal data analysis unit at Imperial College London. In the last 5 years, NM served on the Board of Trustees of the Royal College of Paediatrics and Child Health, David Harvey Trust, Medical Women’s Federation, Medact, Action Cerebral Palsy and Academy of Medical Sciences, and is a member of the Nestle Scientific Advisory Board; received research grants from the British Heart Foundation, Medical Research Council (MRC), National Institute of Health Research, Westminster Research Fund, Collaboration for Leadership in Applied Health and Care Northwest London, Healthcare Quality Improvement Partnership, Bliss, Prolacta Life Sciences, Chiesi, Shire, HCA International, Health Data Research UK and European Health Data Research Network; received travel and accommodation expenses from Prolacta, Nestle and Chiesi; and received honoraria from Medela for contributions to expert advisory boards, and Chiesi for contributing to a lecture programme. CG was funded by the UK Medical Research Council through a Clinician Scientist Fellowship award; received support from Chiesi Pharmaceuticals to attend an educational conference; in the past 5 years, he was investigator on received research grants from MRC, National Institute of Health Research, Canadian Institute of Health Research, Department of Health in England, Mason Medical Research Foundation, Westminster Medical School Research Trust and Chiesi Pharmaceuticals. This article presents independent research supported by the National Institute for Health Research (NIHR). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Objectives: To examine neonates in Scotland aged 0-27 days with SARS-CoV-2 infection confirmed by viral testing; the risk of confirmed neonatal infection by maternal and infant characteristics; and hospital admissions associated with confirmed neonatal infections., Design: Population-based cohort study., Setting and Population: All live births in Scotland, 1 March 2020-31 January 2022., Results: There were 141 neonates with confirmed SARS-CoV-2 infection over the study period, giving an overall infection rate of 153 per 100 000 live births (141/92 009, 0.15%). Among infants born to women with confirmed infection around the time of birth, the confirmed neonatal infection rate was 1812 per 100 000 live births (15/828, 1.8%). Two-thirds (92/141, 65.2%) of neonates with confirmed infection had an associated admission to neonatal or (more commonly) paediatric care. Six of these babies (6/92, 6.5%) were admitted to neonatal and/or paediatric intensive care; however, none of these six had COVID-19 recorded as their main diagnosis. There were no neonatal deaths among babies with confirmed infection., Implications and Relevance: Confirmed neonatal SARS-CoV-2 infection was uncommon over the first 23 months of the pandemic in Scotland. Secular trends in the neonatal confirmed infection rate broadly followed those seen in the general population, although at a lower level. Maternal confirmed infection at birth was associated with an increased risk of neonatal confirmed infection. Two-thirds of neonates with confirmed infection had an associated admission to hospital, with resulting implications for the baby, family and services, although their outcomes were generally good. Ascertainment of confirmed infection depends on the extent of testing, and this is likely to have varied over time and between groups: the extent of unconfirmed infection is inevitably unknown., Competing Interests: Competing interests: CG and JJK are lead investigators for the British Paediatric Surveillance Unit study 'Neonatal complications of COVID-19' and coinvestigators for the 'SARS-CoV-2 infection in neonates or in pregnancy: outcomes at 18 months (SINEPOST)' study., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Perinatal trials sometimes require rapid recruitment processes to facilitate inclusion of participants when interventions are time-critical. A two-stage consent pathway has been used in some trials and is supported by national guidance. This pathway includes seeking oral assent for participation during the time-critical period followed by informed written consent later. This approach is being used in the fluids exclusively enteral from day one (FEED1) trial where participants need to be randomised within 3 hours of birth. There is some apprehension about approaching parents for participation via the oral assent pathway. The main reasons for this are consistent with previous research: lack of a written record, lack of standardised information and unfamiliarity with the process. Here, we describe how the pathway has been implemented in the FEED1 trial and the steps the trial team have taken to support sites. We provide recommendations for future trials to consider if they are considering implementing a similar pathway. Trial registration number: ISRCTN89654042., Competing Interests: Competing interests: The authors declare receiving grant funding to conduct the FEED1 trial. CG declares receiving funding via the MRC for a Clinician Scientist Fellowship, which supported his salary over the time spent on this work., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Optimal timing for neonatal stoma closure remains unclear. In this study, we aimed to establish current practice and illustrate multidisciplinary perspectives on timing of stoma closure using an online survey sent to all 27 UK neonatal surgical units, as part of a research programme to determine the feasibility of a clinical trial comparing 'early' and 'late' stoma closure. 166 responses from all 27 units demonstrated concordance of opinion in target time for closure (6 weeks most commonly stated across scenarios), although there was a high variability in practice. A sizeable proportion (41%) of respondents use weight, rather than time, to determine when to close a neonatal stoma. Thematic analysis of free text responses identified nine key themes influencing decision-making; most related to nutrition, growth and stoma complications. These data provide an overview of current practice that is critical to informing an acceptable trial design., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Objective: To evaluate whether in preterm neonates parenteral nutrition use in the first 7 postnatal days, compared with no parenteral nutrition use, is associated with differences in survival and other important morbidities. Randomised trials in critically ill older children show that harms, such as nosocomial infection, outweigh benefits of early parenteral nutrition administration; there is a paucity of similar data in neonates., Design: Retrospective cohort study using propensity matching including 35 maternal, infant and organisational factors to minimise bias and confounding., Setting: National, population-level clinical data obtained for all National Health Service neonatal units in England and Wales., Patients: Preterm neonates born between 30 +0 and 32 +6 weeks +days ., Interventions: The exposure was parenteral nutrition administered in the first 7 days of postnatal life; the comparator was no parenteral nutrition., Main Outcome Measures: The primary outcome was survival to discharge from neonatal care. Secondary outcomes comprised the neonatal core outcome set., Results: 16 292 neonates were compared in propensity score matched analyses. Compared with matched neonates not given parenteral nutrition in the first postnatal week, neonates who received parenteral nutrition had higher survival at discharge (absolute rate increase 0.91%; 95% CI 0.53% to 1.30%), but higher rates of necrotising enterocolitis (absolute rate increase 4.6%), bronchopulmonary dysplasia (absolute rate increase 3.9%), late-onset sepsis (absolute rate increase 1.5%) and need for surgical procedures (absolute rate increase 0.92%)., Conclusions: In neonates born between 30 +0 and 32 +6 weeks' gestation, those given parenteral nutrition in the first postnatal week had a higher rate of survival but higher rates of important neonatal morbidities. Clinician equipoise in this area should be resolved by prospective randomised trials., Trial Registration Number: NCT03767634., Competing Interests: Competing interests: JWHW has received support from Chiesi Pharmaceuticals to attend an educational conference and has received a research grant from Mason Medical Research Foundation. SNU has received funding from the National Institute of Health Research, the Department of Health and Prolacta Life Sciences. SNU has been on the Advisory Board of Fresenius Kabi and received honoraria and travel expenses for speaking at study days organised by Fresenius Kabi. SNU is a member of the National Institute for Health and Care Excellence Parenteral Nutrition Guideline Development Committee. NM is the Chief Investigator for the National Neonatal Research Database and Director of the Neonatal Data Analysis Unit at Imperial College London. In the last 5 years, NM has served on the Board of Trustees of the Royal College of Paediatrics and Child Health, David Harvey Trust, Medical Women’s Federation and Medact; and is a member of the Nestle Scientific Advisory Board. NM has received research grants from the British Heart Foundation, Medical Research Council, National Institute of Health Research, Westminster Research Fund, Collaboration for Leadership in Applied Health and Care Northwest London, Healthcare Quality Improvement Partnership, Bliss, Prolacta Life Sciences, Chiesi, Shire and HCA International; travel and accommodation expenses from Nutricia, Prolacta, Nestle and Chiesi; honoraria from Ferring Pharmaceuticals and Alexion Pharmaceuticals for contributions to expert advisory boards, and Chiesi for contributing to a lecture programme. CG is part of an international team developing reporting guidance (a CONSORT extension) for clinical trials using cohorts and routinely collected health data. He has received support from Chiesi Pharmaceuticals to attend an educational conference; in the past 5 years he has been an investigator on received research grants from Medical Research Council, National Institute of Health Research, Canadian Institute of Health Research, Department of Health in England, Mason Medical Research Foundation, Westminster Medical School Research Trust and Chiesi Pharmaceuticals, and has been an unremunerated member of the Neonatal Data Analysis Unit Board, which oversees the NNRD., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Parenteral nutrition is commonly administered during therapeutic hypothermia. Randomised trials in critically ill children indicate that parenteral nutrition may be harmful., Objective: To examine the association between parenteral nutrition during therapeutic hypothermia and clinically important outcomes., Design: Retrospective, population-based cohort study using the National Neonatal Research Database; propensity scores were used to create matched groups for comparison., Setting: National Health Service neonatal units in England, Scotland and Wales., Participants: 6030 term and near-term babies, born 1/1/2010 and 31/12/2017, who received therapeutic hypothermia; 2480 babies in the matched analysis., Exposure: We compared babies that received any parenteral nutrition during therapeutic hypothermia with babies that did not., Main Outcome Measures: Primary outcome: blood culture confirmed late-onset infection; secondary outcomes: treatment for late onset infection, necrotising enterocolitis, survival, length of stay, measures of breast feeding, hypoglycaemia, central line days, time to full enteral feeds, discharge weight., Results: 1475/6030 babies (25%) received parenteral nutrition. In comparative matched analyses, the rate of culture positive late onset infection was higher in babies that received parenteral nutrition (0.3% vs 0.9%; difference 0.6; 95% CI 0.1, 1.2; p=0.03), but treatment for presumed infection was not (difference 0.8%, 95% CI -2.1 to 3.6, p=0.61). Survival was higher in babies that received parenteral nutrition (93.1% vs 90.0%; rate difference 3.1, 95% CI 1.5, 4.7; p<0.001)., Conclusions: Receipt of parenteral nutrition during therapeutic hypothermia is associated with higher late-onset infection but lower mortality. This finding may be explained by residual confounding. Research should address the risks and benefits of parenteral nutrition in this population., Competing Interests: Competing interests: CG reports grants from Medical Research Council and the National Institute for Health Research during the conduct of the study; grants from National Institute for Health Research, Mason Medical Research Foundation, Rosetrees Foundation and from Canadian Institute for Health Research outside the submitted work. He reports a grant from Chiesi Pharmaceuticals outside of the submitted work for a research study and a personal fee from Chiesi Pharmaceuticals to support attendance at an educational meeting. CG is vice-chair of the NIHR Research for Patient Benefit London Regional Assessment Panel, and has sat on the panel since 2016. CG was an unremunerated member of the Neonatal Data Analysis Unit (NDAU) steering board which oversees the National Neonatal Research Database (NNRD) until August 2020. DJ reports no potential conflicts of interest. NL reports no potential conflicts of interest. CB reports personal fees from AbbVie Pharmaceuticals outside of the submitted work; the personal fee was to support attendance at an educational meeting. CB sits on the NIHR HTA Prioritisation Panel for Maternal, Child and Mental Health Care since November 2019. KO reports no potential conflicts of interest. SO reports grants from the National Institute for Health Research, Medical Research Council, Global Challenges Research Fund, and the Arts and Humanities Research Council outside of the work on this study. JD reports grants from NIHR, the Canadian Institute for Health Research, IWK Heath Centre, Research Nova Scotia, during the study and for the study; grants from NIHR, and grants from Nutrinia, outside the submitted work. The grant from Nutrinia in 2018 was for part of his salary to work as an expert advisor on a trial. He was a member of the NIHR HTA General Board (from 2017 to 2018) and the NIHR HTA Maternity, Newborn and Child Health Panel (from 2013 to 2018)., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Objective: Hypoxic-ischaemic encephalopathy (HIE) remains a leading cause of neonatal mortality and neurodisability. We aimed to determine the incidence of HIE and management patterns against national guidelines., Design: Retrospective cohort study using the National Neonatal Research Database., Setting: Neonatal units in England and Wales., Patients: Infants 34-42 weeks gestational age (GA) with a recorded diagnosis of HIE., Main Outcomes: Incidence of HIE, mortality and treatment with therapeutic hypothermia (TH) were the main outcomes. Temporal changes were compared across two epochs (2011-2013 and 2014-2016)., Results: Among 407 462 infants admitted for neonatal care, 12 195 were diagnosed with HIE. 8166 infants ≥36 weeks GA had moderate/severe HIE, 62.1% (n=5069) underwent TH and mortality was 9.3% (n=762). Of infants with mild HIE (n=3394), 30.3% (n=1027) underwent TH and 6 died. In late preterm infants (34-35 weeks GA) with HIE (n=635, 5.2%), 33.1% (n=210) received TH and 13.1% (n=83) died. Between epochs (2011-2013 vs 2014-2016), mortality decreased for infants ≥36 weeks GA with moderate/severe HIE (17.5% vs 12.3%; OR 0.69, 95% CI 0.59 to 0.81, p<0.001). Treatment with TH increased significantly between epochs in infants with mild HIE (24.9% vs 35.8%, p<0.001) and those born late preterm (34.3% vs 46.6%, p=0.002)., Conclusions: Mortality of infants ≥36 weeks GA with moderate/severe HIE has reduced over time, although many infants diagnosed with moderate/severe HIE do not undergo TH. Increasingly, mild HIE and late preterm infants with HIE are undergoing TH, where the evidence base is lacking, highlighting the need for prospective studies to evaluate safety and efficacy in these populations., Competing Interests: Competing interests: CG has received support from Chiesi Pharmaceuticals to attend an educational conference; in the past 5 years he has been an investigator on received research grants from Medical Research Council, National Institute for Health Research, Canadian Institutes of Health Research, Department of Health in England, Mason Medical Research Foundation, Westminster Medical School Research Trust and Chiesi Pharmaceuticals, and has been an unremunerated member of the Neonatal Data Analysis Unit Board, which oversees the NNRD., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Therapeutic hypothermia is standard of care for babies with moderate/severe hypoxic-ischaemic encephalopathy and is increasingly used for mild encephalopathy., Objective: Describe temporal trends in the clinical condition of babies diagnosed with hypoxic-ischaemic encephalopathy who received therapeutic hypothermia., Design: Retrospective cohort study using data held in the National Neonatal Research Database., Setting: National Health Service neonatal units in England, Wales and Scotland., Patients: Infants born from 1 January 2010 to 31 December 2017 with a recorded diagnosis of hypoxic-ischaemic encephalopathy who received therapeutic hypothermia for at least 3 days or died in this period., Main Outcomes: Primary outcomes: recorded clinical characteristics including umbilical cord pH; Apgar score; newborn resuscitation; seizures and treatment on day 1., Secondary Outcomes: recorded hypoxic-ischaemic encephalopathy grade., Results: 5201 babies with a diagnosis of hypoxic-ischaemic encephalopathy received therapeutic hypothermia or died; annual numbers increased over the study period. A decreasing proportion had clinical characteristics of severe hypoxia ischaemia or a diagnosis of moderate or severe hypoxic-ischaemic encephalopathy, trends were statistically significant and consistent across multiple clinical characteristics used as markers of severity., Conclusions: Treatment with therapeutic hypothermia for hypoxic-ischaemic encephalopathy has increased in England, Scotland and Wales. An increasing proportion of treated infants have a diagnosis of mild hypoxic-ischaemic encephalopathy or have less severe clinical markers of hypoxia. This highlights the importance of determining the role of hypothermia in mild hypoxic-ischaemic encephalopathy. Receipt of therapeutic hypothermia is unlikely to be a useful marker for assessing changes in the incidence of brain injury over time., Competing Interests: Competing interests: JD reports grants from NIHR, during the conduct of the study, and grants from NIHR, outside the submitted work. JD was a member of the NIHR HTA General Board (from 2017 to 2018) and the NIHR HTA Maternity, Newborn and Child Health Panel (from 2013 to 2018). JD was also funded by Nutrinia in 2017 and 2018 for part of his salary to work as an expert advisor on a trial of enteral insulin. SO reports grants from the National Institute of Health Research, Medical Research Council, and the Derby Hospitals Charity. DS reports grants from the National Institute for Health Research, Medical Research Council, Engineering and Physical Sciences Research Council, outside the submitted work. He is also a committee member of the NIHR Research for Patient Benefit East Midlands Regional Assessment Panel and a non-executive director of SurePulse Medical. NM reports grants from the Medical Research Council, National Institute of Health Research, March of Dimes, British Heart Foundation, HCA International, Health Data Research UK, Shire Pharmaceuticals, Chiesi Pharmaceuticals, Prolacta Life Sciences and Westminster Children’s Research Fund, outside the submitted work. She is a member of the scientific advisory board of Nestle International. NM led the development of and directs the National Neonatal Research Database. CG reports grants from Medical Research Council, the National Institute for Health Research, the Mason Medical Research Foundation, Rosetrees Foundation and Canadian Institute for Health Research, outside the submitted work; and grants and personal fees to attend an educational conference from Chiesi Pharmaceuticals, outside the submitted work; he is a voluntary, unremunerated member of the Neonatal Data Analysis Unit Steering Board, which oversees the National Neonatal Research Database (NNRD), and is vice-chair of the NIHR Research for Patient Benefit London Regional Assessment Panel., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To determine the incidence of neonatal abstinence syndrome (NAS) across neonatal units, explore healthcare utilisation and estimate the direct cost to the NHS., Design: Population cohort study., Setting: NHS neonatal units, using data held in the National Neonatal Research Database., Participants: Infants born between 2012 and 2017, admitted to a neonatal unit in England, receiving a diagnosis of NAS (n=6411)., Main Outcome Measures: Incidence, direct annual cost of care (£, 2016-2017 prices), duration of neonatal unit stay (discharge HR), predicted additional cost of care, and odds of receiving pharmacotherapy., Results: Of 524 334 infants admitted during the study period, 6411 had NAS. The incidence (1.6/1000 live births) increased between 2012 and 2017 (β=0.07, 95% CI (0 to 0.14)) accounting for 12/1000 admissions and 23/1000 cot days nationally. The direct cost of care was £62 646 661 over the study period. Almost half of infants received pharmacotherapy (n=2631; 49%) and their time-to-discharge was significantly longer (median 18.2 vs 5.1 days; adjusted HR (aHR) 0.16, 95% CI (0.15 to 0.17)). Time-to-discharge was longer for formula-fed infants (aHR 0.73 (0.66 to 0.81)) and those discharged to foster care (aHR 0.77 (0.72 to 0.82)). The greatest predictor of additional care costs was receipt of pharmacotherapy (additional mean adjusted cost of £8420 per infant)., Conclusions: This population study highlights the substantial cot usage and economic costs of caring for infants with NAS on neonatal units. A shift in how healthcare systems provide routine care for NAS could benefit infants and families while alleviating the burden on services., Competing Interests: Competing interests: CG holds grants from the National Institute of Health Research, the Mason Medical Research Foundation, the Rosetrees Foundation and the Canadian Institute for Health Research. He receives personal fees from Chiesi Pharmaceuticals. Outside of the submitted work, CG is vice-chair of the NIHR Research for Patient Benefit London Regional Assessment Panel. CG is a non-remunerated member of the Neonatal Data Analysis Unit (NDAU) steering board, which oversees the National Neonatal Research Database (NNRD)., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: More effective recruitment strategies like alternative approaches to consent are needed to facilitate adequately powered trials. Witholding Enteral feeds Around Transfusion was a multicentre, randomised, pilot trial that compared withholding and continuing feeds around transfusion. The primary clinical outcome was necrotising enterocolitis. 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. Semistructured 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'., Conclusion: Introducing a novel form of consent proved challenging in practice. The principle of a 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., Competing Interests: Competing interests: CG reports grants from Medical Research Council and the National Institute for Health Research during the conduct of the study; grants from National Institute for Health Research, Mason Medical Research Foundation, Rosetrees Foundation and from Canadian Institute for Health Research outside the submitted work. He reports grants and personal fees from Chiesi Pharmaceuticals outside of the submitted work; the grant is for a research study and the personal fee was to support attendance at an educational meeting. He was an unremunerated member of the Neonatal Data Analysis Unit Board, which oversees the National Neonatal Research Database., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

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., Competing Interests: Competing interests: CG reports grants from Medical Research Council and the NIHR during the conduct of the study; grants from NIHR, Mason Medical Research Foundation, Rosetrees Foundation and from Canadian Institute for Health Research outside the submitted work. He reports grants and personal fees from Chiesi Pharmaceuticals outside of the submitted work; the grant is for a research study, and the personal fee was to support attendance at an educational meeting. CG is vice-chair of the NIHR Research for Patient Benefit London Regional Assessment Panel and has sat on the panel since 2016. JD reports grants from NIHR, during the conduct of the study for the study; grants from NIHR, and grants from Nutrinia, outside the submitted work. The grant from Nutrinia in 2018 was for part of his salary to work as an expert advisor on a trial. JD was a member of the NIHR HTA General Board (from 2017 to 2018) and the NIHR HTA Maternity, Newborn and Child Health Panel (from 2013 to 2018). FV reports personal fees from BAXTER, personal fees from NUTRICIA, outside the submitted work. LT is an NIHR HTA panel member., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Neonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals., Objective: To define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting., Design: Outcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results., Participants: Four hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey; 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting., Results: The literature reviews identified 104 outcomes; these were included in round 1. Participants proposed 10 additional outcomes; 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia., Conclusions and Relevance: A COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care., Competing Interests: Competing interests: JWHW has received support from Chiesi Pharmaceuticals to attend an educational conference and has received a research grant from Mason Medical Research Foundation. AG has held grants from various manufacturers (Abbott Laboratories, MedImmune) and ventilator manufacturers (SLE). AG has received honoraria for giving lectures and advising various manufacturers (Abbott Laboratories, MedImmune) and ventilator manufacturers (SLE). AG is currently receiving a non-conditional educational grant from SLE. NMa has received consultancy fees from Shire and Novartis and is Chair of the long-term outcomes group for the International Neonatal Consortium, Critical Path Institute. NMo is Director of the Neonatal Data Analysis Unit at Imperial College London. In the last 5 years NMo has served on the Board of Trustees of the Royal College of Paediatrics and Child Health, David Harvey Trust, Medical Women’s Federation and Medact; and is a member of the Nestle Scientific Advisory Board. NMo has received research grants from the British Heart Foundation, Medical Research Council, National Institute of Health Research, Westminster Research Fund, Collaboration for Leadership in Applied Health Research and Care Northwest London, Healthcare Quality Improvement Partnership, Bliss, Prolacta Life Sciences, Chiesi, Shire and HCA International; travel and accommodation expenses from Nutricia, Prolacta, Nestle and Chiesi; honoraria from Ferring Pharmaceuticals and Alexion Pharmaceuticals for contributions to expert advisory boards; and Chiesi for contributing to a lecture programme. CG is part of an international team developing reporting guidance (a CONSORT extension) for clinical trials using cohorts and routinely collected health data. He has received support from Chiesi Pharmaceuticals to attend an educational conference; in the past 5 years he has been investigator on received research grants from Medical Research Council, National Institute of Health Research, Canadian Institutes of Health Research, Department of Health in England, Mason Medical Research Foundation, Westminster Medical School Research Trust and Chiesi Pharmaceuticals., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Competing Interests: Competing interests: All authors are investigators on the BPSU Neonatal Complications of COVID-19 study.

Objective: Inconsistent outcome selection and reporting in clinical trials are important sources of research waste; it is not known how common this problem is in neonatal trials. Our objective was to determine whether large clinical trials involving infants receiving neonatal care report a consistent set of outcomes, how composite outcomes are used and whether parents or former patients were involved in outcome selection., Design: A literature search of CENTRAL, CINAHL, EMBASE and MEDLINE was conducted; randomised trials published between 1 July 2012 and 1 July 2017 and involving at least 100 infants in each arm were included. Outcomes and outcome measures were extracted and categorised by physiological system; reported former patient and parent involvement in outcome selection was extracted., Results: Seventy-six trials involving 43 126 infants were identified; 216 different outcomes with 889 different outcome measures were reported. Outcome reporting covered all physiological systems but was variable between individual trials: only 67/76 (88%) of trials reported survival and 639 outcome measures were only reported in a single trial. Thirty-three composite outcomes were used in 41 trials. No trials reported former patient or parent involvement in outcome selection., Conclusions: Inconsistent outcome reporting and a lack of parent and former patient involvement in outcome selection in neonatal clinical trials limits the ability of such trials to answer clinically meaningful questions. Developing and implementing a core outcome set for future neonatal trials, with input from all stakeholders, should address these issues., Competing Interests: Competing interests: CG is part of an international team developing reporting guidance (a CONSORT extension) for clinical trials using cohorts and routinely collected health data. He has received support from Chiesi Pharmaceuticals to attend an educational conference; in the past 5 years, he had been the investigator on received research grants from Medical Research Council, National Institute of Health Research, Canadian Institute of Health Research, Department of Health in England, Mason Medical Research Foundation, and Westminster Medical School Research Trust and Chiesi Pharmaceuticals; JW has received support from Chiesi Pharmaceuticals to attend an educational conference and has received a research grant from Mason Medical Research Foundation., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: In 2015, the Department of Health in England announced an ambition to reduce 'brain injuries occurring during or soon after birth'. We describe the development of a pragmatic case definition and present annual incidence rates., Design: Retrospective cohort study using data held in the National Neonatal Research Database (NNRD) extracted from neonatal electronic patient records from all National Health Service (NHS) neonatal units in England, Wales and Scotland. In 2010-2011, population coverage in the NNRD was incomplete, hence rate estimates are presented as a range; from 2012, population coverage is complete, and rates (95% CIs) are presented. Rates are per 1000 live births., Setting: NHS neonatal units in England., Patients: Infants admitted for neonatal care; denominator: live births in England., Main Outcome Measure: 'Brain injuries occurring at or soon after birth' defined as infants with seizures, hypoxic-ischaemic encephalopathy, stroke, intracranial haemorrhage, central nervous system infection and kernicterus and preterm infants with cystic periventricular leucomalacia., Results: In 2010, the lower estimate of the rate of 'Brain injuries occurring at or soon after birth' in England was 4.53 and the upper estimate was 5.19; in 2015, the rate was 5.14 (4.97, 5.32). For preterm infants, the population incidence in 2015 was 25.88 (24.51, 27.33) and 3.47 (3.33, 3.62) for term infants. Hypoxic-ischaemic encephalopathy was the largest contributor to term brain injury, and intraventricular/periventricular haemorrhage was the largest contributor to preterm brain injury., Conclusions: Annual incidence rates for brain injuries can be estimated from data held in the NNRD; rates for individual conditions are consistent with published rates. Routinely recorded clinical data can be used for national surveillance, offering efficiencies over traditional approaches., Competing Interests: Competing interests: CG is funded by the United Kingdom Medical Research Council (MRC) through a Clinician Scientist Fellowship award. In the last 5 years, CG has received grants and fellowships from National Institute ofHeath Research (NIHR) and the Academy of Medical Sciences; he has been awarded British Association of Perinatal Medicine (BAPM) Travel Awards, which are supported by Chiesi Pharmaceuticals, to attend educational conferences outside the submitted work. In the last 5 years, NM has received and grants from the National Institute of Heath Research, Medical Research Council, British Heart Foundation, Westminster Children’s Trust Fund, NHS England and Bliss and consultancy fees from Ferring Pharmaceuticals. CG, YS, SJ and NM work in the Neonatal Data Analysis Unit (NDAU), which houses the National Neonatal Research Database (NNRD); CG, SJ and NM do not receive salary or other financial reimbursement from the NDAU. During preparation of this manuscript, YS was employed by the NDAU as a data analyst., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objective: Randomised controlled trials, a gold-standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined whether methodological approaches to facilitate large, efficient clinical trials were acceptable to UK research ethics committees (RECs)., Design: We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: (i) point-of-care design using electronic patient records for patient identification, randomisation and data acquisition, (ii) short two-page information sheet; (iii) explicit mention of possible inclusion benefit; (iv) opt-out consent with enrolment as the default. With the support of the UK Health Research Authority, we submitted an identical protocol to 12 UK REC., Setting: RECs in the UK., Main Outcome: Number of REC granting favourable opinions., Results: The use of electronic patient records was acceptable to all RECs; one REC raised concerns about the short parent information sheet, 10 about inclusion benefit and 9 about opt-out consent. Following responses to queries, nine RECs granted a favourable final opinion and three rejected the application because they considered the opt-out consent process invalid., Conclusions: A majority of RECs in this study consider the use of electronic patient record data, short information sheets, opt-out consent and mention of possible inclusion benefit to be acceptable in neonatal comparative-effectiveness research. We identified a need for guidance for RECs in relation to opt-out consent processes. These methods provide opportunity to facilitate large randomised controlled trials., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Objective: Maternal glycaemia and anthropometry-derived newborn adiposity are strongly correlated. The children of mothers with diabetes are at greater risk of adverse metabolic health, and increased adiposity is a plausible mediator. We undertook a systematic review and meta-analysis to compare adiposity in infants of diabetic mothers (IDM) and infants of mothers without diabetes (NIDM)., Design: We identified observational studies reporting adiposity in IDM and NIDM. We searched references, traced forward citations and contacted authors for additional data. We considered all body composition techniques and compared fat mass, fat-free mass, body fat % and skinfold thickness. We used random effects meta-analyses and performed subgroup analyses by maternal diabetes type (type 1, type 2 and gestational) and infant sex. We examined the influence of pre-pregnancy body mass index (BMI) and conducted sensitivity analyses., Results: We included data from 35 papers and over 24 000 infants. IDM have greater fat mass than NIDM (mean difference (95% CI)): 83 g (49 to 117). Fat mass is greater in infants of mothers with gestational diabetes: 62 g (29 to 94) and type 1 diabetes: 268 g (139 to 397). Insufficient studies reported data for type 2 diabetes separately. Compared with NIDM, fat mass was greater in IDM boys: 87 g (30 to 145), but not significantly different in IDM girls: 42 g (-33 to 116). There was no attenuation after adjustment for maternal BMI., Conclusions: IDM have significantly greater adiposity in comparison with NIDM. These findings are justification for studies to determine whether measures to reduce infant adiposity will improve later health., Competing Interests: KML and NM declare financial support for the submitted work from an Action Medical Research Fellowship; CG, MJH and SS have received funding from the National Institute of Health Research and NM has held research grants awarded by the National Institute of Health Research, Wellcome Trust, Action Medical Research, Child Growth Foundation, Department of Health, Westminster Medical School Research Trust, Healthcare Quality Improvement Partnership, HCA International and Bliss. CG's contribution to this study was supported by an Academy of Medical Sciences Starter Grant for Clinical Lecturers (supported by the Medical Research Council, Wellcome Trust, British Heart Foundation, Arthritis Research UK, Prostate Cancer UK and The Royal College of Physicians) and through a MRC Clinician Scientist Fellowship., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Performing magnetic resonance investigations in a paediatric population can be difficult; image acquisition is commonly complicated by movement artefact and non-compliance. Sedation is widely used for clinically indicated investigations, but there is controversy when used for research imaging. Over a 10-year period we have performed whole body MRI on over 450 infants and hepatic magnetic resonance spectroscopy on over 270 infants. These investigations have been accomplished without the use of sedation in infants up to 3 months of age. Our overall success rate in achieving good quality images free of movement artefact is 94%. The prevalence of incidental findings on whole body (excluding brain) MRI in our cohort was 0.8%. We conclude that the use of sedation for research MRI in this group is not necessary. Our approach to MRI in infancy is also described.