BACKGROUND:Young febrile infants are at high risk of invasive bacterial infections (IBIs). Clinical Decision Aids (CDA) such as the Step-by-Step and Paediatric Emergency Care Applied Research Network (PECARN) use Procalcitonin (PCT), limiting their application in settings without PCT access. This study aimed to test the performance of these CDAs in a UK cohort. METHODS:This was a planned analysis of the Febrile Infant Diagnostic Assessment and Outcome Study, a large, prospective multicentre observational study conducted across over 30 sites in the UK. Febrile infants (0-90 days of age) with complete biomarker data, who also underwent PCT testing, were included. Two CDAs, PECARN and Step-by-Step, were applied to the cohort, using their recommended low-risk criteria. The diagnostic performance of the CDAs was analysed. RESULTS:Of the 1527 infants who completed biomarker testing in the main study, 442 had PCT testing and were included, 22 (5%) were diagnosed with an IBI. PECARN and Step-by-Step CDAs demonstrated sensitivities of 1.00 (95% CI: 0.85 to 1.00) and 0.96 (95% CI: 0.77 to 1.00) respectively. The PECARN CDA performed with a specificity of 0.14 (95% CI: 0.11 to 0.18) identifying 14% of the participants as low-risk and did not misclassify any infants. The Step-by-Step CDA performed with a specificity of 0.15 (95% CI: 0.12 to 0.19) identifying 14% of the participants as low-risk and misclassifying one participant with IBI as low-risk. CONCLUSION:Both PECARN and Step-by-Step CDAs demonstrated high sensitivity for detecting IBI in our cohort. While specificity was relatively low, these tools could potentially identify a subset of low-risk infants suitable for less intensive management.

Background Urinary tract infections (UTIs) are the most common serious bacterial infections in febrile infants. Current UK guidelines recommend parenteral antibiotics for infants under three months with suspected UTI, despite evidence supporting oral therapy in low-risk infants. Objectives To assess whether oral antibiotics are non-inferior to parenteral antibiotics for treating suspected UTIs based on treatment failure, need for additional therapy, and secondary outcomes. Design Multicentre, randomised controlled, open-label, non-inferiority trial with embedded internal pilot. Setting Twenty one paediatric emergency departments and assessment units across the UK. Participants Infants aged 29–90 days with suspected UTI, abnormal urinalysis, and low risk of invasive bacterial infection. Exclusion criteria included prematurity, prior hospitalisation, structural renal abnormalities, and clinical signs of sepsis or meningitis. Interventions Participants were randomised 1:1 to receive either oral antibiotics or standard care with intravenous (IV) antibiotics for 36–48 hours pending urine culture results. Main outcome measures The primary outcome was the requirement for additional parenteral antibiotics within seven days of randomisation. A range of secondary outcomes were also planned, including treatment failure, time to recovery, adverse events, antibiotic adherence, quality of life, family impact, and healthcare resource use. Feasibility outcomes collected during the internal pilot included recruitment rate, site activation, protocol adherence, and retention. Clinical outcomes were collected but not powered for formal comparison. Results 27 participants were recruited between 20 May 2024 and 13 March 2025 (which included the 6 month internal pilot), representing 27% of the pilot target. Protocol adherence was high, and no cases of meningitis occurred. Two cases of bacteraemia (one per randomised group) had uncomplicated clinical courses. Oral therapy was associated with shorter hospital stays and reduced parental time off work. Conclusions While trial procedures were successfully implemented, recruitment challenges suggest that a larger randomised trial of this treatment comparison is not feasible in this setting. Trial management Northern Ireland Clinical Trials Unit (NICTU) Trial registration ISRCTN Clinical Trials Registry, ISRCTN10907780, Trial Dates 20 May 2024 to 13 March 2025

BACKGROUND:Severely displaced distal radial fractures are among the most common and controversial injuries in children. Despite observational evidence of reliable remodelling with growth in younger children, their alarming radiographic appearance-particularly when completely displaced (off-ended)-has driven routine surgical reduction and fixation. The Children's Radius Acute Fracture Fixation Trial (CRAFFT) aimed to evaluate the clinical and cost-effectiveness of surgical reduction compared with non-surgical casting. METHODS:This pragmatic, multicentre, randomised, non-inferiority trial included participants (aged 4-10 years) with a severely displaced distal radial fracture from 49 hospitals in the UK. Recruiting centres were secondary or tertiary care hospitals providing acute paediatric trauma care. Participants were randomly assigned to either non-surgical casting or surgical reduction, using a minimisation algorithm with a random element and stratification factors were centre, age group, fracture location, and displacement severity. Participants and their parents and carers could not be masked to treatment. Surgical reduction was performed under general anaesthesia or conscious sedation, to restore anatomical alignment, with fixation permitted at the discretion of the surgeon. Non-surgical care involved immobilisation of the fracture in a plaster cast without general anaesthesia or sedation, and without purposeful manipulation of the fracture position. Immobilisation of the fracture beyond 6 weeks post-randomisation was not recommended. The primary outcome was upper limb function at 3 months, measured using the Patient Report Outcomes Measurement System (PROMIS) Upper Extremity Score for Children in the intention-to-treat population, which included all participants in the groups to which they were randomly assigned, irrespective of treatment received. The non-inferiority margin was conservatively set at -2·5 points for the main trial population. A prespecified subgroup analysis was powered to assess whether non-surgical casting could exclude a larger more clinically relevant margin of -5 points among children with completely off-ended fractures. Complications and serious adverse events were summarised in a safety (as-treated) population defined by treatment received. A within-trial economic evaluation was undertaken from the perspective of the UK National Health Service (NHS) and Personal Social Services over a 12-month time period. The trial was registered with the ISRCTN registry, ISRCTN10931294, recruitment is complete and extended follow-up to 3-years post-randomisation is ongoing. FINDINGS:Between Aug 11, 2020, and May 30, 2024, 1227 children were screened for eligibility across 49 UK hospitals. 477 children were excluded (54 met exclusion criteria and 423 did not enter the study, the majority for lack of clinical or parental equipoise). 750 participants were randomly assigned, 375 to the non-surgical casting group and 375 to the surgical reduction group. 456 (61%) participants were male, 294 (39%) were female, and the median age of participants was 7·9 years (IQR 6·5-9·5). 329 (44%) of the 750 participants had completely off-ended fractures. Primary outcome data were collected from 640 (85%) participants. At 3 months post-randomisation, the mean PROMIS Upper Extremity score was 44·9 (SD 8·7) in the non-surgical casting group and 46·6 (8·8) in the surgical reduction group (adjusted mean difference -1·64 [95% CI -2·84 to -0·44]), with the confidence interval favouring surgical reduction but extending beyond the prespecified non-inferiority margin of -2·5 points. In children with completely off-ended fractures, findings were consistent with non-inferiority against the wider, prespecified margin for this group. Most complications within 8 weeks occurred in the surgical reduction group, including pressure damage (n=2), wound infections (n=6), scarring (n=5), and nerve irritation (n=1). During the 12-months of follow-up, refracture occurred in 13 participants (nine after non-surgical casting and four after surgical reduction). From an NHS and Personal Social Services perspective, non-surgical casting was associated with a significant reduction in mean cost per patient of £1665 (95% CI 1487 to 1843) and a marginal incremental reduction in quality-adjusted life-years (QALYs; -0·023 [95% CI -0·037 to -0·009]). The probability of non-surgical casting being cost-effective at the £20 000 and £30 000 per QALY threshold was 100%, indicating that the small short-term functional advantage of surgical reduction was not cost-effective. INTERPRETATION:The CRAFFT trial did not demonstrate non-inferiority of non-surgical casting at 3 months against a conservative margin; however, the observed difference in favour of surgical reduction was small, below thresholds that families considered meaningful, and did not persist beyond early recovery. Surgical reduction was associated with higher costs, early procedural complications, and only a modest improvement in cosmetic appearance, supporting consideration of a cast-first strategy for most children. FUNDING:National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (17/22/02) and the NIHR Oxford Biomedical Research Centre.

This study explores clinician leaders understanding and perception at site level towards machine learning (ML) decision support tools for paediatric related emergency care across the UK and Ireland, essential in guiding safe and effective frontline implementation. A cross-sectional online survey was distributed via Paediatric Emergency Research United Kingdom and Ireland (PERUKI) to the lead for digital systems or PERUKI site lead, with one response sought per site. Survey development was in REDCap, and descriptive analysis (counts, percentages) was primarily performed. The response rate was 86.7% (65/75), mostly from England (83.1%). While 80.0% understood 'Artificial Intelligence', fewer understood advanced concepts such as 'Deep Learning' (32.3%). Most clinicians believed ML will support decision making (83.1%), would be willing to use (87.7%), and the future of decision making is a combination of human and ML (83.1%). Barriers included concerns about bias (61.5%), ML accuracy (56.9%), and inadequate information technology infrastructure (67.7%). Digital leads were more concerned about ML accuracy than non-digital (68.2% vs. 51.2%). Among potential applications, antimicrobial stewardship ranked highest (90.8%), and diagnosis of mental health conditions lowest (24.6%). Strong interest in ML tools for decision support in paediatric emergency care was evident, though concerns about bias, accuracy, and infrastructure must be addressed. Ongoing co-design with clinicians is critical in ensuring these tools are trusted, useful and suited to paediatric emergency care. Targeted education, digital leadership, and strategic investment in infrastructure and governance are essential for the successful adoption and integration of ML in clinical workflows.

Background: In late summer 2024, the United Kingdom (UK) introduced the maternal bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine for all pregnant individuals at a gestation of 28 weeks or more. After an initial catch-up phase, the maternal RSVpreF programme transitioned to year-round delivery, and in late summer 2025 nirsevimab replaced palivizumab for UK infants at high risk of severe RSV disease. We aimed to estimate the protection provided by maternal RSVpreF against hospitalisation with RSV in infants up to the age of 6 months, and to assess the overall performance of the UK RSV prevention programme, once this had entered a steady state. Methods: We conducted a multi-centre, test-negative study to analyse the effectiveness of maternal RSVpreF vaccination against the primary outcome of admission to hospital for RSV-associated acute lower respiratory tract infection (ALRI) in infants up to 6 months of age. Patient and public involvement from a group of parents informed study protocol design. Included patients were infants less than 6 months of age at the time of hospital admission, hospitalised with ALRI from September 2, 2025 to January 31, 2026, and tested for RSV. Infants were followed until hospital discharge or death whilst an inpatient. Primary vaccine effectiveness (VE) of maternal RSVpreF vaccination against RSV-associated hospitalisation for infants born at a gestation of 28 weeks or more, excluding nirsevimab recipients, was calculated with the use of a conditional logistic regression model adjusted by site, calendar month of attendance, gestational age at birth, socioeconomic status, age at admission and breastfeeding status. Secondary analyses included describing facilitators and barriers to maternal vaccine uptake, and an assessment of the overall protection provided by the UK infant RSV prevention programme to all infants, regardless of gestational age at birth. Findings: ​The primary analysis included 658 infants from 37 study sites in England, Scotland, Northern Ireland and Wales born at a gestation of 28 weeks or more who had not received nirsevimab: 402 RSV-positive cases (median age, 2.2 months, interquartile range 1.3-3.9 months) and 256 RSV-negative controls (median age, 1.6 months, interquartile range 1.0-3.2 months). Of recruited infants, 373/658 (57%) were male. Ethnicity data was available for 657 mothers; of these 517 (79%) identified as being of white ethnicity. The mothers of 158 RSV-positive case patients (39%) and 173 RSV-negative control patients (68%) had received the RSVpreF vaccine prior to delivery. The adjusted effectiveness of maternal RSVpreF vaccination for preventing infant hospitalisation was 62% (95% confidence interval [CI] 38-76) for infants up to 6 months of age, and 78% (95% CI 57-89) for infants up to 3 months of age. Twenty-three percent of mothers recruited had received pertussis vaccination during pregnancy but not RSVpreF. In this group, responses to a quantitative survey indicated that limited access to RSVpreF, safety concerns, and uncertainty about the necessity of RSVpreF all contributed to vaccine non-receipt. The overall effectiveness of the UK RSV prevention programme was 62% (95% CI 39-76) through to 6 months of age. ​ Interpretation: In the real-world setting of the UK's maternal vaccination programme, RSVpreF vaccination was effective up until the age of 6 months in reducing the risk of hospital admission with RSV ALRI, as was the UK&apo

Background The original research priorities for paediatric emergency medicine (PEM) in the UK and Ireland were published in 2015. This list, generated through a modified Delphi process involving healthcare professionals only, has driven the research agenda for over ten years. With many now successfully addressed and a significantly altered healthcare landscape, there was a pressing need to refresh PEM research priorities with the input of patients and carers.Methods James Lind Alliance (JLA) methodology was employed. The scope included unscheduled emergency care provided to children and young people irrespective of setting. An independent JLA facilitator chaired monthly steering group meetings with equal input from parents and healthcare professionals. Two online surveys were employed to generate a list of evidence uncertainties and then to prioritise research questions from key stakeholder groups (patients, carers and healthcare professionals). An online workshop subsequently used an adapted nominal group technique to reach a consensus on the top list of research priorities.Results 655 questions were submitted in Survey 1 by 338 respondents (35% patients and carers and 65% healthcare professionals). After merging questions by topic and removing out-of-scope questions, 70 summary questions proceeded to evidence reviews; three were found to have been sufficiently answered. Further merging of summary questions resulted in 46 indicative research questions for Survey 2, which received 542 complete responses (26.6% patients and carers, 73.4% healthcare professionals). The 18 highest-ranking questions were brought to the consensus workshop, in which 12 patients/carers and 15 healthcare professionals reached consensus on the 10 highest priority research questions.Conclusion This refreshed PEM prioritisation study has identified the top 10 research priorities reflecting the views of patients, carers and a range of health professionals across the UK and Ireland. These priorities will be used to drive the PEM research agenda for the next decade.

BACKGROUND:Respiratory syncytial virus (RSV) is a leading cause of infant hospitalisation due to lower respiratory tract infections. Until 2022, prevention was limited to the costly monoclonal antibody palivizumab. In August 2024, the UK introduced the RSVpreF (Abrysvo, Pfizer) maternal vaccine into its national immunisation schedule. The success of this programme depends not only on vaccine effectiveness, but also on maternal access, acceptance and uptake. OBJECTIVE:To explore maternal perspectives on the RSVpreF vaccine and identify barriers and facilitators to vaccine uptake, to inform antenatal education and public health strategies. METHODS:This qualitative analysis is based on free-text survey responses from 388 vaccine-eligible mothers of infants hospitalised with bronchiolitis, lower respiratory tract infection or acute wheeze, collected between September 2024 and March 2025 across 30 sites, as part of the BronchStop study. RESULTS:Four key themes were identified: (1) access-related barriers to vaccination, (2) insufficient RSV awareness and information to support informed decision-making, (3) vaccine safety concerns and hesitancy and (4) perception of the maternal RSV vaccine as beneficial and protective. These themes were consistent across sociodemographic groups. CONCLUSIONS:Uptake of the maternal vaccine was influenced by barriers to access, informational gaps and perceived safety concerns. Improved vaccine delivery, enhanced awareness and personalised antenatal counselling are essential to increase vaccine uptake. There is an urgent need to address structural inaccessibility and provide tailored antenatal education to address informational gaps. Ongoing qualitative research is crucial to guide targeted public health interventions ahead of future RSV seasons.

BACKGROUND:In late summer, 2024, the UK introduced the maternal bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine for all pregnant individuals at a gestation of 28 weeks or more. After an initial catch-up phase, the maternal RSVpreF programme transitioned to year-round delivery, and in late summer, 2025, nirsevimab replaced palivizumab for infants at high risk of severe RSV disease. We aimed to estimate the protection provided by maternal RSVpreF against hospital admission with RSV in infants up to the age of 6 months, and to assess the overall performance of the UK RSV prevention programme once this had entered a steady state. METHODS:We conducted a national, multicentre, prospective, test-negative, case-control study at 37 BronchStop hospital sites in the UK. Patient and public involvement from a group of parents informed study protocol design. Included patients were prospectively enrolled infants aged 6 months or younger at the time of hospital admission with acute lower respiratory tract infection (ALRI) and tested for RSV. Test-positive infants (case patients) were defined as those admitted with a positive RSV test. Test-negative infants (control patients) were defined as those who tested negative for RSV. Infants were followed up until hospital discharge or death while an inpatient. The primary outcome was infant hospital admission with RSV-associated ALRI in infants born at a gestation of 28 weeks or more who did not receive nirsevimab postnatally. Primary vaccine effectiveness was calculated with the use of a conditional logistic regression model adjusted by site, calendar month of attendance, gestational age at birth, socioeconomic status, age at admission, and breastfeeding status. This study was registered with ClinicalTrials.gov, NCT04959734. FINDINGS:Between Sept 2, 2025, and Jan 31, 2026, 1356 infants were admitted to participating sites and screened for eligibility, 694 of whom were included in the primary analysis (429 RSV-positive infants and 265 RSV-negative infants). Median age was 2·2 months (IQR 1·3-3·9) for RSV-positive infants and 1·7 months (1·0-3·3) for RSV-negative infants. 394 (57%) of 694 infants were male and 300 (43%) were female. Ethnicity data were available for 693 mothers, of whom 538 (78%) identified as being of White ethnicity. The mothers of 161 (38%) RSV-positive infants and 175 (66%) RSV-negative infants had received the RSVpreF vaccine before delivery. The adjusted vaccine effectiveness of maternal RSVpreF vaccination for preventing infant hospital admission was 61% (95% CI 38-75) for infants aged up to 6 months, and 76% (54-87) for infants aged up to 3 months. The overall effectiveness of the UK RSV prevention programme was 61% (39-75) through to age 6 months. INTERPRETATION:In the real-world setting of the UK's maternal vaccination programme, RSVpreF vaccination was effective up until the age of 6 months in reducing the risk of hospital admission with RSV-associated ALRI, as was the UK's infant RSV prevention programme. These data could help decision makers to evaluate whether RSVpreF or an anti-RSV infant monoclonal antibody best serves the needs of their infant population. FUNDING:National Institute for Health and Care Research, The Wellcome Trust, Imperial College London, the Public Health Agency Northern Ireland, the Belfast Health and Social Care Trust Charitable Trust Funds, the Edinburgh Children's Hospital Charity, and the Respiratory Syncytial Virus Consortium in Europe.

Background Urinary tract infections (UTIs) are the most common serious bacterial infections in febrile infants. Current UK guidelines recommend parenteral antibiotics for infants under three months with suspected UTI, despite evidence supporting oral therapy in low-risk infants. Objectives To assess whether oral antibiotics are non-inferior to parenteral antibiotics for treating suspected UTIs based on treatment failure, need for additional therapy, and secondary outcomes. Design Multicentre, randomised controlled, open-label, non-inferiority trial with embedded internal pilot. Setting Twenty one paediatric emergency departments and assessment units across the UK. Participants Infants aged 29–90 days with suspected UTI, abnormal urinalysis, and low risk of invasive bacterial infection. Exclusion criteria included prematurity, prior hospitalisation, structural renal abnormalities, and clinical signs of sepsis or meningitis. Interventions Participants were randomised 1:1 to receive either oral antibiotics or standard care with intravenous (IV) antibiotics for 36–48 hours pending urine culture results. Main outcome measures The primary outcome was the requirement for additional parenteral antibiotics within seven days of randomisation. A range of secondary outcomes were also planned, including treatment failure, time to recovery, adverse events, antibiotic adherence, quality of life, family impact, and healthcare resource use. Feasibility outcomes collected during the internal pilot included recruitment rate, site activation, protocol adherence, and retention. Clinical outcomes were collected but not powered for formal comparison. Results 27 participants were recruited between 20 May 2024 and 13 March 2025 (which included the 6 month internal pilot), representing 27% of the pilot target. Protocol adherence was high, and no cases of meningitis occurred. Two cases of bacteraemia (one per randomised group) had uncomplicated clinical courses. Oral therapy was associated with shorter hospital stays and reduced parental time off work. Conclusions While trial procedures were successfully implemented, recruitment challenges suggest that a larger randomised trial of this treatment comparison is not feasible in this setting. Trial management Northern Ireland Clinical Trials Unit (NICTU) Trial registration ISRCTN Clinical Trials Registry, ISRCTN10907780, Trial Dates 20 May 2024 to 13 March 2025

IMPORTANCE:Methoxyflurane, an inhalational analgesic, has proven safety and efficacy in clinical trials and clinical practice. This double-blind, well-controlled study aimed to establish the benefit-risk of methoxyflurane in a paediatric population. OBJECTIVE:To evaluate the safety and efficacy of methoxyflurane in children with minor trauma and acute pain presenting to emergency departments (ED). DESIGN:Randomised, double-blind, multicentre, placebo-controlled study (MAGPIE). SETTING:Conducted at 11 EDs in the UK and Ireland. PARTICIPANTS:Participants aged from 6-<18 years of age with minor trauma and pain scores of 60-80 mm on a visual analogue scale (VAS), or 6-8 on a Wong Baker Pain Scale, were recruited. INTERVENTIONS:Methoxyflurane 3 mL or placebo (normal saline, 5 mL) via a Penthrox® inhaler device, with a second inhaler upon request. MAIN OUTCOME(S) AND MEASURE(S):Primary: change in VAS pain intensity from baseline to 15-minutes in participants aged 9-<18 years (secondary: included the total Intent-To-Treat (ITT) population, aged 6-<18 years). RESULTS:4513 patients screened, 249 participants randomised (127 methoxyflurane, 122 placebo), 192 treated (92 methoxyflurane, 100 placebo). Mean (standard deviation (SD)) age 11.1 (2.45) years; 108/192 (56 %) were male. At 15-minutes, the mean change from baseline in VAS was -20.0 mm (methoxyflurane) and -13.2 mm (placebo); least squares (LS) mean difference in 9-<18-year old's -6.8 mm [95 % CI -12.5 to -1.2 mm], p = 0.018, which was similar to the total ITT population. Fewer methoxyflurane participants required rescue medication (9.8 % vs 30.0 %). There were statistically significant odds of better global medication performance assessments for the methoxyflurane group compared to the placebo group, based on physician (OR 5.29, 95 % CI 3.02 to 9.45, p < 0.001) and research nurse assessments (OR 5.78, 95 % CI 3.32 to 10.27, p < 0.001). Adverse events were more common with methoxyflurane (64 %) vs. placebo (55 %). Common treatment emergent adverse events (TEAEs) included dizziness (methoxyflurane 41 %, placebo 12 %) and euphoric mood (methoxyflurane 12 %, placebo 0 %). Discontinuations due to TEAEs occurred in 8 methoxyflurane and 1 placebo participant. There were no serious adverse events related to methoxyflurane. CONCLUSIONS AND RELEVANCE:In this pivotal placebo-controlled trial, methoxyflurane was efficacious for treatment of acute trauma-related pain in paediatrics, with a safety profile consistent with adults. TRIAL REGISTRATION:NCT03215056.

BACKGROUND:Head-injured children are commonly transported to the Emergency Department (ED) by ambulance. However, most of those conveyed are deemed non-serious and are discharged at triage. Hospital clinicians use clinical decision tools to support their assessment of head-injured children; however, this is generally to determine whether a computed tomography (CT) scan is indicated. Currently, there is no pre-hospital clinical decision tool designed to support paramedics when assessing and managing head-injured children at scene. The aim of this study was to determine consensus amongst experts and stakeholders to inform the development of a new tool to support paramedics in safely assessing and managing children with minor head injury. METHODS:A consultation process using a modified online Delphi technique comprising two rounds and a consensus meeting was completed between September 2023 and January 2024. A 5-point Likert scale was used to assess consensus, set a-priori at 67%. Free text survey responses arising from the Delphi were studied and concepts were developed. Data were analysed anonymously, and feedback was given after each round. RESULTS:An expert stakeholder group comprising 36 participants took part in Round One, and 34 participants in Round Two of the online Delphi. The participants included parents/grandparents/caregivers, paramedics, primary care clinicians, ED doctors, ED nurses and Paediatricians. Consensus was reached in 36 statements following Rounds One and Two. The remaining eight statements were discussed at a consensus meeting, which was attended by 12 stakeholders. Seven of the eight statements reached agreement. CONCLUSION:This Delphi study has established consensus amongst a group of experts and stakeholders on the content and format of a pre-hospital paediatric head injury clinical decision tool, designed for use by paramedics: PATCH (Pre-hospital Assessment Tool for Children with Head injury). Future research should include an evaluation of the acceptability and usability of PATCH by paramedics. CLINICAL TRIAL NUMBER:Not applicable.

Abusive head trauma (AHT) in infants is the most common abusive injury in young children, and increased awareness has resulted in the development of prevention programmes. Most research evaluating AHT prevention programmes report parental and carer perspectives. Little is known about barriers and facilitators to adopting, implementing, and maintaining educational programmes from the perspectives of managers and staff delivering the education. ICON is an AHT prevention programme currently being delivered in National Health Service hospital and primary care settings in the United Kingdom. This study evaluated the ICON programme from the perspective of managers and healthcare professionals through the RE-AIM framework using qualitative methods. Fifty-three managers and healthcare professionals across six geographical areas in England participated in individual interviews and focus groups between October 2022 and April 2023. Data collection and analysis were concurrent, systematic, and iterative, using framework analysis as a guide to explore factors impacting ICON’s reach and the key enablers and obstacles to its effectiveness, adoption, implementation, and maintenance. Four primary enablers and related challenges to the ICON programme’s impact were identified. Fidelity to the programme’s recommended touchpoints and message impacted ICON’s reach to new parents and carers. Parental receptiveness to the programme was affected by staff individualising their approach. Staff buy-in was related to staff workload and previous experiences with AHT. Managers with strategic leadership responsibility for reducing infant mortality and able to provide governance oversight fostered successful adoption, implementation, and maintenance of the programme. Staff are willing and able to deliver the ICON programme, including, where necessary, delivering the key messages in a format acceptable to families varying situations, if given the workload and training to do so. Those in leadership positions influence the likelihood of successful adoption, delivery and longer-term mainstreaming, if they are able to prioritise the programme. Understanding the barriers and facilitators to ICON’s delivery has the potential to inform policy by facilitating the uptake of the programme by settings, enabling delivery of ICON to reach the needs of local families, and ensuring sustainability of the ICON programme.

INTRODUCTION:Children with head injury are commonly transported to the ED by ambulance. However, most of those conveyed are deemed non-serious and are discharged at triage. Research is needed to explore the factors that influence paramedics when deciding to convey children with minor head injury to the ED, and to establish whether a clinical decision tool designed to support them would be beneficial. METHODS:A generic qualitative approach, comprising semistructured interviews with front-line ambulance paramedics working in the UK. Interviews were audio-recorded and transcribed. Data were analysed using reflexive thematic analysis. Interviews aimed to explore the factors that influence paramedics when deciding to convey children with minor head injury to the ED. RESULTS:A total of 20 paramedics from several ambulance services participated in interviews. Three overarching themes were identified: 'we just take them in'; 'there are too many hurdles'; 'creating the right tool'. These were further categorised into subthemes. Paramedics do not feel confident when assessing and managing children with head injury, and convey children to hospital due to fear of consequences, despite knowing there will be no intervention in the ED. Further education, a prehospital paediatric clinical decision tool and greater support from Ambulance Trusts would be welcomed by paramedics. Criteria such as: parental anxiety; time; wound closure; policy and non-accidental injury need to be considered in a clinical decision tool designed to support paramedics' management of children with head injury. CONCLUSION:Paramedics generally feel a lack of confidence in assessing and managing children with head injury. A decision tool, coupled with training and useful feedback from EDs following conveyance, would be useful to help improve decision-making.

Introduction In 2021 we launched the BronchStart study, which collected information on 17,899 hospital attendances in children with serious respiratory tract infections following the release of lockdown restrictions. Our study informed the Joint Committee on Vaccination and Immunisation’s (JCVI) decision to recommend the introduction of maternal respiratory syncytial virus (RSV) vaccination, which was rolled out in the United Kingdom in August/September 2024 for all pregnant women at a gestation of 28 weeks or more. That winter we performed the BronchStop study, which examined vaccine effectiveness in its first season, conducted a survey of mothers to understand factors affecting vaccine uptake, and collected RSV positive samples for molecular epidemiology. Methods and analysis In the winter season of 2025-2026 we will conduct a UK-wide, multi-centre, prospective, test-negative case control study. The aim is to assess the effectiveness of maternal RSV vaccination against hospitalisation for RSV-associated acute lower respiratory tract infection (ALRI) amongst infants under the age of 6 months born to vaccine-eligible pregnant mothers. A survey designed in partnership with our public and patient involvement (PPI) group will be administered to mothers of recruited infants to understand factors affecting maternal vaccine uptake. RSV-positive samples will undergo whole genome sequencing, and all samples will undergo real-time, reverse transcriptase polymerase chain reaction (rRT-PCR) testing for a panel of respiratory viruses to understand residual causes of severe infant respiratory disease in the post-vaccination era. Ethics and dissemination Participants recruited to the study will be asked for informed consent to participate in the maternal survey, for researchers to access their vaccination records, and for routinely collected virological samples from their infants to undergo rRT-PCR testing. Regular reports to advisory groups, including JCVI and the World Health Organisation, and for peer-reviewed publications are planned to disseminate findings and inform decision-making.

BACKGROUND:Suboptimal coding and underreporting of abusive head trauma (AHT) makes cases difficult to identify from routinely collected patient data, particularly if not admitted to hospital. OBJECTIVE:To identify existing AHT definitions for routine patient data and compare their impact on AHT incidence estimates when applied to a UK primary care cohort. PARTICIPANTS AND SETTING:Cohort participants were all infants in a large primary care database, who were under 1 year old between January 2013 and June 2021, registered at a General Practice, with linkages to secondary care and Accident and Emergency data. METHOD:A scoping review to identify studies that used diagnostic codes or routinely collected data to define AHT in children under 5 years from electronic health records. We used the definitions identified to calculate incidence per 100,000 person-years in a UK primary care cohort to explore variability of incidence estimates. RESULTS:We identified 40 eligible studies (29 definitions), with most definitions based on hospital data using ICD-9-CM and ICD-10 codes. None applied to a UK population or primary care data sources. Incidence of AHT in our cohort ranged from 9 to 15 per 100,000 person-years using "probable" or "presumptive" definitions, and up to 49 per 100,000 person-years using broader definitions including "possible" AHT. CONCLUSION:The wide range of hospital AHT incidence calculated in our cohort using the definitions identified in the scoping review indicates a need for a standardised definition suited to UK datasets including primary care.

BACKGROUND:Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory infections (ALRI) in infants younger than 6 months globally. A maternal bivalent RSV prefusion F (RSVpreF) vaccine was introduced to the UK in late summer in 2024 (August 12 in Scotland and September 1 in England), with all pregnant women at 28 weeks or more of gestation eligible for vaccination. We aimed to understand RSVpreF vaccine effectiveness in a real-world setting. METHODS:We conducted a multicentre, test-negative, case-control study to analyse the vaccine effectiveness of maternal RSVpreF vaccination against the primary outcome of hospitalisation (ie, admission to hospital) for RSV-associated ALRI in infants. Patient and public involvement from a group of parents informed the study protocol design. Included patients were infants with ALRI born after Aug 12, 2024 (Scotland), and Sept 1, 2024 (England), and therefore had mothers eligible for maternal vaccination, who were admitted to 30 hospital sites across the UK from Sept 30, 2024, to Jan 20, 2025, and tested for RSV. Infants were followed up until hospital discharge or death as an inpatient. Primary vaccine effectiveness of maternal RSVpreF vaccination against RSV-associated hospitalisation was calculated with the use of a conditional logistic regression adjusted by site, calendar month of hospital attendance for the infant, age, preterm birth, and sex. FINDINGS:We included 537 mother-infant pairs, in whom there were 391 RSV-positive infant cases (median age 1·63 months [IQR 0·94-2·26]) and 146 RSV-negative infant controls (1·41 months [0·77-2·03]). Of 537 recruited infants, 297 (55%) were male and 240 (45%) were female. Ethnicity data were available for 533 mothers, of whom 434 (81%) self-identified as White. The mothers of 73 (19%) RSV-positive cases and 60 (41%) RSV-negative controls had received RSVpreF vaccine before delivery. The adjusted effectiveness of maternal RSVpreF vaccination for preventing infant hospitalisation was 58% (95% CI 28-75) for infants whose mothers were vaccinated at any time before delivery and 72% (48-85) for infants whose mothers were vaccinated more than 14 days before delivery (39 [11%] of 357 RSV-positive cases vs 43 [33%] of 129 RSV-negative controls). INTERPRETATION:In the real-world setting of the first season of vaccine implementation in England and Scotland, maternal RSVpreF vaccination was effective and equivalent to trial settings in reducing the risk of hospitalisation in infants with RSV-associated ALRI. FUNDING:National Institute for Health and Care Research, The Wellcome Trust, and Imperial College London.

BACKGROUND:Abusive head trauma (AHT) is a leading cause of head injuries in children under 12 months of age. ICON is an AHT prevention program delivered in the National Health Service (United Kingdom) that educates and provides strategies for new parents on infant crying: infant crying is normal, comforting strategies can help, it's ok to walk away, never shake a baby. Little is known about parental perspectives on ICON and similar programs. OBJECTIVE:This study evaluated ICON from the perspective of new parents, identifying factors that influence its reach and effectiveness in providing tools to cope with a baby who is crying. PARTICIPANTS/SETTING:Twenty-eight new parents of infants aged between two and six months were recruited from six geographic areas across England, selected to reflect ethnic, socioeconomic and regional diversity. METHODS:This qualitative evaluation study interviewed new parents to understand their experiences of ICON. Data collection and analysis were concurrent and iterative. Framework analysis and an ecological framework guided analysis to explore factors affecting ICON's reach and effectiveness. A diverse parent advisory panel informed study design and analysis. RESULTS:ICON messages normalized infant crying for parents, provided comforting strategies and gave them permission to put their baby down when overwhelmed, and reinforced the message to never shake a baby. Mothers were the primary recipient of education. Factors impacting ICON's effectiveness included tailoring education to family needs, presence of family/friend support, and the parent's emotional state. Contextual factors impacted parental receptivity of ICON. CONCLUSIONS:New parents reported the ICON program messages supported them in coping with their babies when they cried. They identified factors to enhance that support; by engaging fathers, by enhancing healthcare professionals' fidelity to the program while personalising the message, and by addressing wider social and contextual conditions that shape everyday caregiving.

Background: Children (6–24 kg) with lower respiratory tract infections were prospectively recruited in emergency departments to high or low doses of oral amoxicillin. We identified children who met the criteria for medium and high risks of sepsis, as per the UK’s National Institute for Health and Care Excellence (NICE). Of those able to be discharged with oral antibiotics; 54% (318/591) had high-risk sepsis criteria. NICE sepsis guidance is poorly specific, with implications for antimicrobial resistance and iatrogenic patient harm. Methods: Children (6–24 kg) with lower respiratory tract infections were prospectively recruited in emergency departments to high or low doses of oral amoxicillin. Results: Of those able to be discharged with oral antibiotics, 54% (318/591) had high-risk sepsis criteria as per the UK’s NICE. Conclusions: NICE sepsis guidance is poorly specific, with implications for antimicrobial resistance and iatrogenic patient harm.