Embedding the 'CoolCuddle' intervention for infants undergoing therapeutic hypothermia for hypoxic-ischaemic encephalopathy in NICU: an evaluation using normalisation process theory.

OBJECTIVES: Newborn infants exposed to lack of oxygen and blood flow to the brain around birth may develop brain dysfunction (hypoxic-ischaemic encephalopathy-HIE). These infants undergo 72 hours of cooling therapy and most are not held by their parents in the UK. We examined the implementation of 'CoolCuddle', identifying factors that impact embedding of this complex intervention in neonatal intensive care units (NICUs) across England. DESIGN: Process evaluation and qualitative study using a standard questionnaire and interviews. Normalisation Process Theory (NPT) core constructs were used to assess relevant issues to staff embedding 'CoolCuddle', to discern change over time and different settings. Qualitative interviews provided valuable contextual exploration of implementation. SETTING AND PARTICIPANTS: Six tertiary NICUs in England. Thirty-seven families with a newborn baby undergoing cooling therapy for HIE were recruited from September 2022 to August 2023; 17 NICU staff Normalisation MeAsure Development (NoMADs) at six NICUs over 6 months were included; 14 neonatal/research nurses from three participating NICUs were interviewed. INTERVENTION: The family-centred intervention 'CoolCuddle' was developed to enable parents to hold their infant during cooling, without affecting the cooling therapy or intensive care. OUTCOME MEASURES: NoMAD questionnaires at three timepoints over 6 months and NPT informed qualitative interviews. RESULTS: NoMAD questionnaires at baseline showed more variation between units, for intervention acceptability, than those at 3 and 6 months. Qualitative data highlighted that staff understood the benefits of CoolCuddle but were apprehensive due to perceived risks involved in moving cooling babies. A rigorous standard operating procedure was flexible enough to incorporate the use of local processes and equipment and provided the relevant procedural knowledge to deliver CoolCuddle safely. CONCLUSIONS: The CoolCuddle intervention can be implemented safely under the supervision of standard neonatal teams as part of usual practice in diverse NICU settings in England. The importance of having a rigorous standard operating procedure, which can be adapted to support local settings, is highlighted. TRIAL REGISTRATION NUMBER: ISRCTN10018542; Results: registered on 30 August 2022.

Cooling and physiology during parent cuddling infants with neonatal encephalopathy in usual care: CoolCuddle-2 study.

AIM: CoolCuddle, enabling parents to cuddle their babies with neonatal encephalopathy (NE) during therapeutic hypothermia and intensive care (TH), was developed in research settings. To determine the impact of implementing CoolCuddle in usual care in six diverse neonatal intensive care units on the cooling process and intensive care. METHODS: This vital sign cohort study embedded within the CoolCuddle implementation study enrolled 36 infants receiving TH for NE. Nurses received training on CoolCuddle and a standard operating procedure using an instruction video. After consenting, parents experienced up to 2 h of CoolCuddle with 30 min of pre- and post-cuddle observation. We used multilevel, clustered linear modelling to assess the physiological stability in temperature, cardio-respiratory and neurophysiology across the CoolCuddle. RESULTS: In 60 CoolCuddles over 93.12 h, respiratory parameters, heart rate or neurological function did not vary between the epochs (p > 0.05). During cuddle, sleep-wake cycling on amplitude-integrated EEG increased (p = 0.008) and there was weak evidence of lower pain scores (p = 0.08). No adverse effects were observed. CONCLUSION: Implementing CoolCuddle with support in usual practice maintained physiological stability and did not significantly affect the cooling process or intensive care, and may improve infant comfort. Ongoing monitoring of adverse effects when implementing CoolCuddle is recommended.

Improving the care of children with GENetic Rare disease: Observational Cohort study (GenROC)-a study protocol.

INTRODUCTION: Around 2000 children are born in the UK per year with a neurodevelopmental genetic syndrome with significantly increased morbidity and mortality. Often little is known about expected growth and phenotypes in these children. Parents have responded by setting up social media groups to generate data themselves. Given the significant clinical evidence gaps, this research will attempt to identify growth patterns, developmental profiles and phenotypes, providing data on long-term medical and educational outcomes. This will guide clinicians when to investigate, monitor or treat symptoms and when to search for additional or alternative diagnoses. METHODS AND ANALYSIS: This is an observational, multicentre cohort study recruiting between March 2023 and February 2026. Children aged 6 months up to 16 years with a pathogenic or likely pathogenic variant in a specified gene will be eligible. Children will be identified through the National Health Service and via self-recruitment. Parents or carers will complete a questionnaire at baseline and again 1 year after recruitment. The named clinician (in most cases a clinical geneticist) will complete a clinical proforma which will provide data from their most recent clinical assessment. Qualitative interviews will be undertaken with a subset of parents partway through the study. Growth and developmental milestone curves will be generated through the DECIPHER website (https://deciphergenomics.org) where 5 or more children have the same genetic syndrome (at least 10 groups expected). ETHICS AND DISSEMINATION: The results will be presented at national and international conferences concerning the care of children with genetic syndromes. Results will also be submitted for peer review and publication.

The RELIEF feasibility trial: topical lidocaine patches in older adults with rib fractures.

BACKGROUND: Lidocaine patches, applied over rib fractures, may reduce pulmonary complications in older patients. Known barriers to recruiting older patients in emergency settings necessitate a feasibility trial. We aimed to establish whether a definitive randomised controlled trial (RCT) evaluating lidocaine patches in older patients with rib fracture(s) was feasible. METHODS: This was a multicentre, parallel-group, open-label, feasibility RCT in seven hospitals in England and Scotland. Patients aged ≥65 years, presenting to ED with traumatic rib fracture(s) requiring hospital admission were randomised to receive up to 3×700 mg lidocaine patches (Ralvo), first applied in ED and then once daily for 72 hours in addition to standard care, or standard care alone. Feasibility outcomes were recruitment, retention and adherence. Clinical end points (pulmonary complications, pain and frailty-specific outcomes) and patient questionnaires were collected to determine feasibility of data collection and inform health economic scoping. Interviews and focus groups with trial participants and clinicians/research staff explored the understanding and acceptability of trial processes. RESULTS: Between October 23, 2021 and October 7, 2022, 206 patients were eligible, of whom 100 (median age 83 years; IQR 74-88) were randomised; 48 to lidocaine patches and 52 to standard care. Pulmonary complications at 30 days were determined in 86% of participants and 83% of expected 30-day questionnaires were returned. Pulmonary complications occurred in 48% of the lidocaine group and 59% in standard care. Pain and some frailty-specific outcomes were not feasible to collect. Staff reported challenges in patient compliance, unfamiliarity with research measures and overwhelming the patients with research procedures. CONCLUSION: Recruitment of older patients with rib fracture(s) in an emergency setting for the evaluation of lidocaine patches is feasible. Refinement of data collection, with a focus on the collection of pain, frailty-specific outcomes and intervention delivery are needed before progression to a definitive trial. TRIAL REGISTRATION NUMBER: ISRCTN14813929.

Adherence to the national guidance on foods and drinks to limit or avoid during pregnancy in England: the PEAR Study.

OBJECTIVE: The National Health Service (NHS) England website provides guidance on foods/drinks to avoid or limit during pregnancy because of microbiological, toxicological or teratogenic hazards. The aims were to determine adherence and whether demographic characteristics were associated with adherence. DESIGN: Cross-sectional study. SETTING: Online survey of postpartum women resident in England during pregnancy. PARTICIPANTS: Recently, postpartum women resident in England during their pregnancy (n 598; median age 33 (IQR 30-36) years) completed an online questionnaire (April-November 2022). Questions included those on consumption of twenty-one food/drink items that the NHS advises pregnant women to avoid/limit. The study is part of the Pregnancy, the Environment And nutRition (PEAR) Study. Summary statistics were used to determine proportions adhering to the guidance. Adjusted logistic regression was used to model the associations of adherence with demographic characteristics. RESULTS: Adherence was generally high (>90 % for eight of ten food/drink items to be avoided). However, among pre-pregnancy consumers, several items were not completely avoided, for example, 81 % (128/158) for game meat/gamebirds, 37 % (176/478) for cured meats and 17 % (81/467) for soft cheeses. Greater educational attainment (e.g. caffeinated soft drinks OR 2·25 (95 % CI 1·28, 3·94)), greater maternal age (e.g. oily fish 1·64 (1·05, 2·56)) and lower parity (e.g. caffeinated coffee 0.28 (0.11, 0.69)) were the most usual characteristics associated with adherence. CONCLUSION: Evidence of concerning levels of non-adherence for some food/drink items suggests a case for more education on some of the guidance, particularly for women with lower educational attainment, greater parity and greater maternal age. Further research on barriers to the implementation of the guidance is needed.

Breast hypoplasia markers among women who report insufficient milk production: A retrospective online survey.

OBJECTIVES: To estimate the proportions of anatomical breast characteristics suggestive of breast hypoplasia among breastfeeding women self-reporting low milk supply. We also explored breast hypoplasia risk factors. DESIGN: Online survey conducted between October 2021 and January 2022. SETTING: Five low milk supply Facebook groups. PARTICIPANTS: 487 women reporting low milk supply with their first child born ≥ 37 weeks gestation within 5 years of participation in this study, and residing in the USA, Australia or the UK. We present data on the primary outcome ('breast type') for 399 women. Women were excluded if the dyad was separated for more than 24 hours during the hospital stay, or if the mother reported removing milk less than 6 times per day from each breast on most days before being aware of having insufficient milk production. PRIMARY AND SECONDARY OUTCOME MEASURES: The proportions of proposed breast hypoplasia markers including atypical breast type, widely spaced breasts, breast asymmetry, stretch marks on the breast and lack of pregnancy breast growth. We also estimated the odds of having breast hypoplasia markers in at-risk groups compared to reference groups, adjusting for covariates. RESULTS: Approximately 68% reported at least one atypical breast (270/399; 95% CI: 62.9%, 72.1%). Around 47% reported widely spaced breasts (212/449; 95% CI: 42.7%, 52.7%), 72% a lack of pregnancy breast growth (322/449; 95% CI: 68.3%, 77.4%), and 76% stretch marks on the breast (191/250; 95% CI: 70.7%, 81.3%). Multiple logistic regression analyses identified being overweight during pubertal years as a risk factor for atypical breast type and lack of pregnancy breast growth. CONCLUSIONS: Participants in low milk supply Facebook groups reported high rates of breast hypoplasia markers. Being overweight during adolescence was a risk factor for breast hypoplasia markers. These findings should be confirmed in well-conducted large cohort studies to determine the strongest combination of hypoplasia markers in predicting low supply.

A Risk Assessment and Planning Tool to Prevent Sudden Unexpected Death in Infancy: Development and Evaluation of The Baby Sleep Planner.

BACKGROUND: Successful national safer sleep campaigns in the United Kingdom have lowered the death rates from sudden unexpected death in infancy (SUDI) over the past 3 decades, but deaths persist in socioeconomically deprived families. The circumstances of current deaths suggest that improvements in support for some families to follow safer sleep advice more consistently could save lives. OBJECTIVE: This study aimed to develop and evaluate a risk assessment and planning tool designed to improve the uptake of safer sleep advice in families with infants at increased risk of SUDI. METHODS: A co-design approach was used to develop the prototype interface of a web-based tool with 2 parts: an individual SUDI risk assessment at birth and a downloadable plan for safety during times of disruption. The advice contained within the tool is concordant with national guidance from the Lullaby Trust, the United Nations International Children's Emergency Fund (UNICEF), and the National Institute for Health and Care Excellence. User testing of the prototype tool was conducted by inviting health visitors, midwives, and family nurses to use it with families eligible for additional support. Qualitative interviews with health professionals and families allowed for iterative changes to the tool and for insights into its function and influence on parental behavior. RESULTS: A total of 22 health professionals were enrolled in the study, of whom 20 (91%) were interviewed. They reported appreciating the functionality of the tool, which allowed them to identify at-risk families for further support. They felt that the tool improved how they communicated about risks with families. They suggested expanding its use to include relevance in the antenatal period and having versions available in languages other than English. They reported using the tool with 58 families; 20 parents gave consent to be interviewed by the research team about their experiences with the tool. Families were positive about the tool, appreciated the trustworthy information, and felt that it was useful and appropriate and that the plans for specific infant sleeps would be of benefit to them and other family members. CONCLUSIONS: Our tool combines risk assessment and safety planning, both of which have the potential to improve the uptake of lifesaving advice. Refinements to the tool based on these findings have ensured that the tool is ready for further evaluation in a larger study before being rolled out to families with infants at increased risk.

Implementation of the CHIldren with acute COugh (CHICO) intervention to improve antibiotics management: a qualitative study in primary care.

BACKGROUND: Childhood respiratory tract infections (RTIs) are common and can lead to unnecessary antibiotic use and antimicrobial resistance. The CHIldren with COugh (CHICO) intervention incorporates a clinician-focused algorithm (STARWAVe) to predict future hospitalisation risk, elicitation of carer concerns, and a carer-focused personalised leaflet recording treatment decisions and safety-netting information. AIM: To examine the implementation of the CHICO intervention by primary care clinicians. DESIGN AND SETTING: A qualitative study with primary care clinicians in England taking part in the CHICO randomised controlled trial. METHOD: Interviews explored the CHICO intervention's acceptability and use. Clinicians from a range of practices with high and low antibiotic dispensing rates were recruited. Normalisation process theory underpinned data collection and thematic analysis. RESULTS: Most clinicians liked the intervention because it was quick and easy to use, it helped elicit carer concerns, and reassured clinicians and carers of the appropriateness of treatment decisions. However, clinicians used it as a supportive aid for treatment decisions rather than as a tool for behaviour change. The accompanying advice leaflet helped explain treatment decisions and support self-care. The intervention did not always align with clinicians' usual processes, which could affect use. Increased familiarisation with the algorithm led to reduced intervention use, which was further reduced during the COVID-19 pandemic as a result of changes to practice and remote consultations. CONCLUSION: Clinicians found the CHICO intervention useful to support decision making around antibiotic prescribing and it helped discussions with carers about concerns and treatment decisions. The intervention may need to be adapted to align more with clinicians' consultation flow and remote consultations.

Quantitative impact of frenotomy on breastfeeding: a systematic review and meta-analysis.

BACKGROUND: Symptoms related to infant ankyloglossia/tongue-tie may deter mothers from breastfeeding, yet frenotomy is controversial. METHODS: Databases included PubMed, Embase, CINAHL, PsycINFO, Web of Science, and Google Scholar from 1961-2023. Controlled trials and cohort studies with validated measures of surgical efficacy for breastfeeding outcomes were eligible. Meta-analyses synthesized data with inverse-variance weighting to determine standardized mean differences (SMD) between pre-/postoperative scores. RESULTS: Twenty-one of 1568 screened studies were included. Breastfeeding self-efficacy improved significantly post-frenotomy: medium effect after 5-10 days (SMD 0.60 [95% CI: 0.48, 0.71; P < 0.001]), large effect after 1 month (SMD 0.91 [CI: 0.79, 1.04; P < 0.001]). Nipple pain decreased significantly post-frenotomy: large effect after 5-15 days (SMD -1.10 [CI: -1.49, -0.70; P < 0.001]) and 1 month (SMD -1.23 [CI: -1.79, -0.67; P = 0.002]). Frenotomy had a medium effect on infant gastroesophageal reflux severity at 1-week follow-up (SMD -0.63 [CI: -0.95, -0.31; P = 0.008]), with continued improvement at 1 month (SMD -0.41 [CI: -0.78, -0.05; P = 0.04]). From LATCH scores, breastfeeding quality improved after 5-7 days by a large SMD of 1.28 (CI: 0.56, 2.00; P = 0.01). CONCLUSIONS: Providers should offer frenotomy to improve outcomes in dyads with ankyloglossia-associated breastfeeding difficulties. PROTOCOL REGISTRATION: PROSPERO identifier CRD42022303838 . IMPACT: This systematic review and meta-analysis showed that breastfeeding self-efficacy, maternal pain, infant latch, and infant gastroesophageal reflux significantly improve after frenotomy in mother-infant dyads with breastfeeding difficulties and ankyloglossia. Providers should offer frenotomy to improve breastfeeding outcomes in symptomatic mother-infant dyads who face challenges associated with ankyloglossia.

Effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation: protocol for a multicentre randomised controlled trial (Version 3.0).

INTRODUCTION: Breastfeeding has health benefits for infants and mothers, yet the UK has low rates with marked social inequalities. The Assets-based feeding help Before and After birth (ABA) feasibility study demonstrated the acceptability of a proactive, assets-based, woman-centred peer support intervention, inclusive of all feeding types, to mothers, peer supporters and maternity services. The ABA-feed study aims to assess the clinical and cost-effectiveness of the ABA-feed intervention compared with usual care in first-time mothers in a full trial. METHODS AND ANALYSIS: A multicentre randomised controlled trial with economic evaluation to explore clinical and cost-effectiveness, and embedded process evaluation to explore differences in implementation between sites. We aim to recruit 2730 primiparous women, regardless of feeding intention. Women will be recruited at 17 sites from antenatal clinics and various remote methods including social media and invitations from midwives and health visitors. Women will be randomised at a ratio of 1.43:1 to receive either ABA-feed intervention or usual care. A train the trainer model will be used to train local Infant Feeding Coordinators to train existing peer supporters to become 'infant feeding helpers' in the ABA-feed intervention. Infant feeding outcomes will be collected at 3 days, and 8, 16 and 24 weeks postbirth. The primary outcome will be any breastfeeding at 8 weeks postbirth. Secondary outcomes will include breastfeeding initiation, any and exclusive breastfeeding, formula feeding practices, anxiety, social support and healthcare utilisation. All analyses will be based on the intention-to-treat principle. ETHICS AND DISSEMINATION: The study protocol has been approved by the East of Scotland Research Ethics Committee. Trial results will be available through open-access publication in a peer-reviewed journal and presented at relevant meetings and conferences. TRIAL REGISTRATION NUMBER: ISRCTN17395671.

Maternal vaccination provision in NHS maternity trusts across England.

BACKGROUND: Vaccinations for seasonal influenza and pertussis have been recommended for pregnant women in England since 2010 and 2012, respectively. Uptake rates are suboptimal with large regional variations. To improve uptake, from 2016 onwards maternity trusts were commissioned to offer pertussis (and other) vaccinations in addition to these being available in primary care. Since 2021, Covid-19 vaccination has also been recommended for pregnant women. Overall maternal vaccination rates are routinely available, but not the relative provision by maternity trusts. We aimed to describe the national picture of maternity trust provision of maternal vaccinations, including how the maternity trust vaccination programme has progressed. METHODS: Cross-sectional survey plus comparisons with 2017-18 figures for maternity trust provision of pertussis vaccination, and with UKHSA data for total pertussis vaccination. RESULTS: Twelve NHS commissioners participated (from 13/06/22 to 31/03/23) providing data for 120 (of a total 124) maternity trusts across England. All 120 (100%) trusts were commissioned to deliver influenza, and 107 (89%) to deliver pertussis vaccinations, though not all actually administered the vaccines; 29% offered Covid-19 vaccinations. For 2021-22 we found a mean of 25% (range 0-81.3%) women were vaccinated for pertussis (a large increase compared with previous estimates for 2017-18); and 11% (range 0-74.2%) for influenza, via their maternity trust. Commissioners reported a negative impact of the pandemic on routine vaccination provision. There was indication of efficiency by vaccinating women attending for other appointments. There are diverse mechanisms for reporting pertussis and influenza vaccinations administered at maternity trusts back to primary care, which may be inefficient for maternity staff workload and accuracy of data transfer (especially for pertussis). CONCLUSION: A high proportion of maternity trusts provide both pertussis and influenza vaccinations, despite a negative impact of the pandemic. Reasons for large between-trust variation in vaccination rates should be explored to improve uptake and equity.

Text message conversations between peer supporters and women to deliver infant feeding support using behaviour change techniques: A qualitative analysis.

OBJECTIVE: To analyse text message conversations between peer supporters (called Infant Feeding Helpers - IFHs) and new mothers using qualitative methods to understand how peer support can influence and support women's feeding experiences. DESIGN: Qualitative analysis of text messages conversations using both inductive thematic and deductive content approaches to coding. Thematic analysis of the text message transcripts and deductive content analysis was used to code if Behaviour Change Techniques (BCTs) were employed by IFHs in their interactions with women. BCTs coded in text messages were then compared with those tabulated from antenatal meeting recordings and documented in interview transcripts. PARTICIPANTS AND SETTING: 18 primiparous women and 7 Infant Feeding Helpers from one community site in South-West England. FINDINGS: Three key themes were identified in the18 text message conversations (1679 texts): 'breastfeeding challenges', 'mother-centred conversations', and 'emotional and practical support'. The core BCTs of 'social support' and 'changing the social environment' were found at least once in 17 (94 %) and 18 (100 %) text message conversations respectively. Meanwhile, 'instruction to perform the behaviour' was used at least once in over 50 % of conversations. Generally, the use of BCTs was greatest between birth and two weeks during a period of daily texts when women reported many feeding challenges. The number and range of BCTs used in text messages were similar to those documented in audio-recorded meetings and interview accounts. CONCLUSION AND IMPLICATIONS: Infant Feeding Helpers were able to provide engaging and successful breastfeeding peer support through text messages. Messaging was shown to be an appropriate and accessible method of delivering BCTs focussing on 'social support' and 'changing the social environment'. Peer supporters delivering BCTs via text messages is acceptable and appropriate to use if in-person support is limited due to unforeseen circumstances such as the COVID-19 pandemic.

Changes in background characteristics and risk factors among SIDS infants in England: cohort comparisons from 1993 to 2020.

OBJECTIVES: Using the National Child Mortality Database, this work aims to investigate background characteristics and risk factors in the sleeping environment associated with sudden infant death syndrome (SIDS) and compare the prevalence with previous English SIDS case-control studies. DESIGN: Cohort of SIDS in 2020 compared with a combined analysis of two case-control studies conducted in 1993-1996 and 2003-2006. SETTING: England, UK PARTICIPANTS: 138 SIDS deaths in 2020 compared with 402 SIDS deaths and 1387 age-equivalent surviving controls, combined from previous studies. RESULTS: The increased vulnerability of SIDS infants identified in previous studies has become more marked. The infants who died in 2020 were younger (median=66 days (IQR: 34-118) vs 86 days (IQR: 52-148), p=0.003) with an increased prevalence of low birth weight (30.5% vs 21.6%, p=0.04) and preterm births (29.6% vs 19.3%, p=0.012). The excess of socioeconomically deprived families, male infants and high levels of maternal smoking during pregnancy were still evident. Among recent deaths, fewer infants were put down or found on their side; however, there was no significant change in the proportion of infants who were put down (15.6% vs 14.6%, p=0.81) and found prone (40.4% vs 35.3%, p=0.37), despite population wide risk reduction advice over three decades. The proportional increase observed in 2003-2006 of half the deaths occurring while sleeping next to an adult was maintained in 2020, and for the vast majority (90%), this was in hazardous circumstances (adult had consumed alcohol, smoked, slept on a sofa, or the infant was premature or low birth weight and less than 3 months old). More deaths also occurred when there was a disruption in infant care routine compared with previous observations (52.6% vs 20.7%, p<0.001). CONCLUSIONS: A more targeted approach is needed with vulnerable families emphasising the importance of sleeping infants on their back and proactive planning infant sleep when there are disruptions to the normal routine, in particular to avoid hazardous co-sleeping.

The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF): feasibility trial protocol.

Background: Topical lidocaine patches, applied over rib fractures, have been suggested as a non-invasive method of local anaesthetic delivery to improve respiratory function, reduce opioid consumption and consequently reduce pulmonary complications. Older patients may gain most benefit from improved analgesic regimens yet lidocaine patches are untested as an early intervention in the Emergency Department (ED). The aim of this trial is to investigate uncertainties around trial design and conduct, to establish whether a definitive randomised trial of topical lidocaine patches in older patients with rib fractures is feasible. Methods: RELIEF is an open label, multicentre, parallel group, individually randomised, feasibility randomised controlled trial with economic scoping and nested qualitative study. Patients aged ≥ 65 years presenting to the ED with traumatic rib fracture(s) requiring admission will be randomised 1:1 to lidocaine patches (intervention), in addition to standard clinical management, or standard clinical management alone. Lidocaine patches will be applied immediately after diagnosis in ED and continued daily for 72 hours or until discharge. Feasibility outcomes will focus on recruitment, adherence and follow-up data with a total sample size of 100. Clinical outcomes, such as 30-day pulmonary complications, and resource use will be collected to understand feasibility of data collection. Qualitative interviews will explore details of the trial design, trial acceptability and recruitment processes. An evaluation of the feasibility of measuring health economics outcomes data will be completed. Discussion: Interventions to improve outcomes in elderly patients with rib fractures are urgently required. This feasibility trial will test a novel early intervention which has the potential of fulfilling this unmet need. The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF) feasibility trial will determine whether a definitive trial is feasible. ISRCTN Registration: ISRCTN14813929 (22/04/2021).

BACKGROUND AND AIMS: Patches containing a numbing medication (lidocaine), put on the skin over broken ribs, may help to improve outcomes in older people. We will carry out a clinical trial of these patches, to see whether this research would work in Accident and Emergency (A&E) and whether patients will take part. DESIGN: We will ask 100 older people who need to stay in hospital with broken ribs to take part in this research. We will ask permission from relatives to include people with dementia. We will put those who agree to take part into one of two groups by chance. One group will have the patch put over their broken ribs in A&E for up to 3 days, along with usual pain killers if needed. We will treat people in the other group in the normal way, without a patch. We will track how many people are willing to take part. We will collect information on patient recovery in the 30 days after going to A&E and ask people to complete questionnaires about their health. We will interview patients and clinicians to get feedback. Patient and Public Involvement: Patient volunteers helped us design this research and will provide advice throughout. They agreed that including older people was appropriate, people with dementia and their carers should take part, and side-effects of strong pain killers are important to patients. FINDINGS: We will use the research findings to develop a larger trial to see if lidocaine patches help patients with broken ribs. We will write up results for scientific journals, speak at conferences and to our patient group.

Implementation of flash glucose monitoring in four pediatric diabetes clinics: controlled before and after study to produce real-world evidence of patient benefit.

AIMS: To assess the real-world evidence for flash glucose monitoring (Abbott FreeStyle Libre) for children with type 1 diabetes in terms of glucose control, secondary healthcare resources and costs. RESEARCH DESIGN AND METHODS: We conducted a controlled before and after study (approximately 12 months before and after) using routinely collected health record data on children who start using flash monitors and a control population of children with self-monitoring of blood glucose (SMBG). Our population-based sample of eligible individuals using flash monitoring (n=114) and controls (n=80) aged between 4 and 18 years was drawn from four paediatric diabetes clinics (secondary care) in the South West England. Outcome measures included: glycated hemoglobin (HbA1c), frequency of BG tests; frequency of sensor scans; time in recommended glucose range; short-term complications (hypoglycemia, diabetic ketoacidosis and related illness resulting in investigation) and secondary care costs. RESULTS: After adjustment for age, time since diagnosis, deprivation and the test modality (point of care or laboratory), the mean HbA1c reading for controls was 61.2 (mmol/mol) for the period before and 63.9 after. For individuals using flash monitoring, the adjusted mean HbA1c reading was 64.6 for the period before implementation and 63.8 after. Rates of short-term complications were low across all groups in the study. Whereas the 'after' flash monitoring group had substantially higher incremental costs (+£703 vs the flash monitoring 'before' comparison and +£841 vs contemporaneous SMBG controls), these cost differences were driven by primary care prescribing (sensor costs). CONCLUSIONS: There was some indication that flash monitoring might help young people improve the control of their diabetes but for our sample, the difference between finger-prick testing and flash monitoring was not clinically significant (HbA1c improvement <5 mmol/mol). Given the pace of technological change within diabetes, research efforts should now facilitate the real-time analysis of long-term routine data on flash and continuous glucose monitors.

Fish Consumption during Pregnancy in Relation to National Guidance in England in a Mixed-Methods Study: The PEAR Study.

Guidance on foods to limit or avoid in pregnancy is provided on the NHS website for England. Advice on fish consumption is related to exposure to mercury, dioxins and polychlorinated biphenyls, which may have adverse effects on fetal neurodevelopment. Our aim was to provide evidence on the effectiveness of the guidance in minimising exposure to toxins while maximising nutrient intake in a mixed-methods study. An online questionnaire on fish consumption before/during pregnancy was completed by postpartum women (≤12 months) in England (n = 598). A subsample of participants was invited to take part in an interview (n = 14). Women who ate fish before pregnancy reduced their intakes of both oily and white fish during pregnancy, with some avoiding it altogether. Women did not exceed the limit on tinned tuna, but there was evidence of mis-recall on the suggested limit. Overall intakes of fish were below that recommended during pregnancy (36% compliance for pre-pregnancy consumers). Barriers to fish consumption included risk aversion, confusion over specific details of the guidance, cost, availability, family preferences and smell/taste. Clarity and simplicity of the NHS guidance, with an overall message on the number of portions of fish a week advised prominently shown, would help pregnant women to benefit from the nutrients in fish while minimising exposure to toxins. The guidance on the number of cans of tuna advised per week is poorly recalled and needs to be disseminated accurately. The guidance on shark/marlin/swordfish could receive less prominence as it is rarely eaten by pregnant women in England.

Multi-faceted intervention to improve management of antibiotics for children presenting to primary care with acute cough and respiratory tract infection (CHICO): efficient cluster randomised controlled trial.

OBJECTIVE: To assess whether an easy-to-use multifaceted intervention for children presenting to primary care with respiratory tract infections would reduce antibiotic dispensing, without increasing hospital admissions for respiratory tract infection. DESIGN: Two arm randomised controlled trial clustered by general practice, using routine outcome data, with qualitative and economic evaluations. SETTING: English primary care practices using the EMIS electronic medical record system. PARTICIPANTS: Children aged 0-9 years presenting with respiratory tract infection at 294 general practices, before and during the covid-19 pandemic. INTERVENTION: Elicitation of parental concerns during consultation; a clinician focused prognostic algorithm to identify children at very low, normal, or elevated 30 day risk of hospital admission accompanied by antibiotic prescribing guidance; and a leaflet for carers including safety netting advice. MAIN OUTCOME MEASURES: Rate of dispensed amoxicillin and macrolide antibiotics (superiority comparison) and hospital admissions for respiratory tract infection (non-inferiority comparison) for children aged 0-9 years over 12 months (same age practice list size as denominator). RESULTS: Of 310 practices needed, 294 (95%) were randomised (144 intervention and 150 controls) representing 5% of all registered 0-9 year olds in England. Of these, 12 (4%) subsequently withdrew (six owing to the pandemic). Median intervention use per practice was 70 (by a median of 9 clinicians). No evidence was found that antibiotic dispensing differed between intervention practices (155 (95% confidence interval 138 to 174) items/year/1000 children) and control practices (157 (140 to 176) items/year/1000 children) (rate ratio 1.011, 95% confidence interval 0.992 to 1.029; P=0.25). Pre-specified subgroup analyses suggested reduced dispensing in intervention practices with fewer prescribing nurses, in single site (compared with multisite) practices, and in practices located in areas of lower socioeconomic deprivation, which may warrant future investigation. Pre-specified sensitivity analysis suggested reduced dispensing among older children in the intervention arm (P=0.03). A post hoc sensitivity analysis suggested less dispensing in intervention practices before the pandemic (rate ratio 0.967, 0.946 to 0.989; P=0.003). The rate of hospital admission for respiratory tract infections in the intervention practices (13 (95% confidence interval 10 to 18) admissions/1000 children) was non-inferior compared with control practices (15 (12 to 20) admissions/1000 children) (rate ratio 0.952, 0.905 to 1.003). CONCLUSIONS: This multifaceted antibiotic stewardship intervention for children with respiratory tract infections did not reduce overall antibiotic dispensing or increase respiratory tract infection related hospital admissions. Evidence suggested that in some subgroups and situations (for example, under non-pandemic conditions) the intervention slightly reduced prescribing rates but not in a clinically relevant way. TRIAL REGISTRATION: ISRCTN11405239ISRCTN registry ISRCTN11405239.

Flash glucose monitoring in young people with type 1 diabetes-a qualitative study of young people, parents and health professionals: 'It makes life much easier'.

OBJECTIVES: Flash glucose monitoring for patients with T1 diabetes avoids frequent painful finger-prick testing, thus potentially improving frequency of glucose self-monitoring. Our study aimed to explore experiences of young people using Freestyle Libre sensors and their parents, and to identify benefits and challenges to National Health Service (NHS) staff of its adoption in their care provision. PARTICIPANTS: Young people with T1 diabetes, their parents and healthcare professionals were interviewed between February and December 2021. Participants were recruited via social media and through NHS diabetes clinic staff. DESIGN: Semistructured interviews were conducted online and analysed using thematic methods. Staff themes were mapped onto normalisation process theory (NPT) constructs. RESULTS: Thirty-four participants were interviewed: 10 young people, 14 parents and 10 healthcare professionals. Young people reported that life was much easier since changing to flash glucose monitoring, increasing confidence and independence to manage their condition. Parents' quality of life improved and they appreciated access to real-time data. Using the NPT concepts to understand how technology was integrated into routine care proved useful; health professionals were very enthusiastic about flash glucose monitoring and coped with the extra data load to facilitate more tailored patient support within and between clinic visits. CONCLUSION: This technology empowers young people and their parents to understand their diabetes adherence more completely; to feel more confident about adjusting their own care between clinic appointments; and provides an improved interactive experience in clinic. Healthcare teams appear committed to delivering improving technologies, acknowledging the challenge for them to assimilate new information required to provide expert advice.

Provision of information by midwives for pregnant women in England on guidance on foods/drinks to avoid or limit.

BACKGROUND: The National Health Service (NHS) website gives guidance for pregnant women in England on foods/drinks to avoid or limit because of microbiological, toxicological or teratogenic hazards. These include, for example, some types of soft cheeses, fish/seafood and meat products. This website and midwives are trusted sources of information for pregnant women, but the ways in which midwives can be supported to provide clear and accurate information are unknown. AIMS: The aims were to: (1) determine midwives' accuracy of recall of information and confidence in delivering the guidance to women; (2) identify barriers to provision; (3) identify the ways in which midwives provide this information to women. METHODS: Registered Midwives practicing in England completed an online questionnaire. Questions included those on what information they provided and their confidence in delivering it, the ways they provided information on foods to avoid/limit, their recall of some of the guidance, and what resources they used. Ethics approval was given by the University of Bristol. RESULTS: More than 10% of midwives (n = 122) were 'Not at all confident/Don't know' in providing advice about ten items, including game meat/gamebirds (42% and 43%, respectively), herbal teas (14%) and cured meats (12%). Only 32% correctly recalled overall advice on eating fish, and only 38% the advice on tinned tuna. The main barriers to provision were lack of time in appointments and lack of training. The most usual methods of disseminating information were verbal (79%) and signposting to websites (55%). CONCLUSION: Midwives were often unconfident about their ability to provide accurate guidance, and recall on items tested was frequently mistaken. Delivery of guidance by midwives on foods to avoid or limit needs to be supported by appropriate training and access to resources, and sufficient time in appointments. Further research on barriers to the delivery and implementation of the NHS guidance is needed.

Severity and prevalence of ankyloglossia-associated breastfeeding symptoms: A systematic review and meta-analysis.

AIM: To evaluate breastfeeding symptoms associated with ankyloglossia/tongue-tie. METHODS: Databases included PubMed, Embase, CINAHL, PsycINFO, Web of Science, and Google Scholar. Eligible studies reported baseline breastfeeding symptoms/severity from tongue-tied infants. Two reviewers independently screened studies, extracted data, and assessed quality. Low-quality studies were excluded. Main outcomes were weighted mean severity scores for dyads with ankyloglossia relative to reference values for successful breastfeeding. Meta-analyses used inverse-variance-weighted random-effects models. RESULTS: Of 1328 screened studies, 39 were included (5730 infants with ankyloglossia). The mean LATCH score for patients with untreated ankyloglossia, 7.1 (95% CI: 6.7-7.4), was significantly below the good-breastfeeding threshold. The mean Infant Breastfeeding Assessment Tool score, 10.0 (8.2-11.7), was not significantly below the good-breastfeeding threshold. The mean Infant-Gastroesophageal Reflux Questionnaire-Revised score, 18.2 (10.5-26.0), was consistent with gastroesophageal reflux disease. The mean Breastfeeding Self-Efficacy Scale-Short Form score, 43.7 (39.3-48.1), indicated significant risk of cessation of exclusive breastfeeding within 1-3 months. Mean nipple pain was 4.9 (4.1-5.7) on a 0-10 scale, greater than typical scores for breastfeeding mothers without nipple damage. Total prevalence of breastfeeding difficulties was 49.3% (95% CI: 47.3-51.4%). Early, undesired weaning occurred in 20.3% (18.5-22.2%) of cases before intervention. CONCLUSION: Ankyloglossia is adversely associated with breastfeeding success and maternal well-being.