Neonates
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Azithromycin therapy for prevention of chronic lung disease of prematurity (AZTEC): a multicentre, double-blind, randomised, placebo-controlled trialBackground: Systematic reviews have reported conflicting evidence on whether macrolide antibiotics reduce rates of chronic lung disease of prematurity (CLD) in at-risk preterm infants born at less than 30 weeks' gestation, including in those colonised with pulmonary Ureaplasma spp. Since an adequately powered trial has been lacking, we aimed to assess if the macrolide azithromycin improved survival without the development of physiologically defined moderate or severe CLD in preterm infants. Methods: AZTEC was a multicentre, double-blind, randomised, placebo-controlled trial conducted in 28 tertiary neonatal intensive care units in the UK. Infants were eligible if they were born at less than 30 weeks' gestation and had received at least 2 h of either non-invasive (continuous positive airway pressure or humidified high flow nasal cannula therapy) or invasive respiratory support (via endotracheal tube) within 72 h of birth. Eligible infants were randomly allocated in a 1:1 ratio using random permuted blocks of four to receive either intravenous azithromycin at 20 mg/kg per day for 3 days followed by 10 mg/kg for 7 days, or to placebo. Allocation was stratified by centre and gestational age at birth (<28 weeks vs ≥28 weeks). Azithromycin and placebo vials were encased in tamper-evident custom cardboard cartons to ensure masking for clinicians, parents, and the research team. The primary outcome was survival without development of physiologically defined moderate or severe CLD at 36 weeks' postmenstrual age. Outcomes and safety were analysed on an intention-to-treat basis (all randomly allocated infants, regardless of any post-randomisation events). The study was registered with ISRCRN (11650227) and is closed. Findings: Infants were recruited between Oct 9, 2019, and March 22, 2022. 799 (53·1%) of 1505 eligible infants underwent random allocation; three infants were withdrawn, including consent to use their data, leaving 796 infants for analysis. Survival without moderate or severe CLD occurred in 166 (42%) of 394 infants in the intervention group and 179 (45%) of 402 in the placebo group (three-level adjusted OR [aOR] 0·84, 95% CI 0·55-1·29, p=0·43). Pulmonary Ureaplasma spp colonisation did not influence treatment effect. Overall, seven serious adverse events were reported for the azithromycin group (five graded as severe, two as moderate), and six serious adverse events were reported in the placebo group (two severe, two moderate, and two mild), as assessed by the local principal investigators. Interpretation: Since prophylactic use of azithromycin did not improve survival without development of physiologically-defined CLD, regardless of Ureaplasma spp colonisation, it cannot be recommended in clinical practice. Funding: UK National Institute for Health and Care Research.
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A national survey of hereditary angioedema and acquired C1 inhibitor deficiency in the United KingdomBackground: Detailed demographic data on people with hereditary angioedema (HAE) and acquired C1 inhibitor deficiency in the United Kingdom are relatively limited. Better demographic data would be beneficial in planning service provision, identifying areas of improvement, and improving care. Objective: To obtain more accurate data on the demographics of HAE and acquired C1 inhibitor deficiency in the United Kingdom, including treatment modalities and services available to patients. Methods: A survey was distributed to all centers in the United Kingdom that look after patients with HAE and acquired C1 inhibitor deficiency to collect these data. Results: The survey identified 1152 patients with HAE-1/2 (58% female and 92% type 1), 22 patients with HAE with normal C1 inhibitor, and 91 patients with acquired C1 inhibitor deficiency. Data were provided by 37 centers across the United Kingdom. This gives a minimum prevalence of 1:59,000 for HAE-1/2 and 1:734,000 for acquired C1 inhibitor deficiency in the United Kingdom. A total of 45% of patients with HAE were on long-term prophylaxis (LTP) with the most used medication being danazol (55% of all patients on LTP). Eighty-two percent of patients with HAE had a home supply of acute treatment with C1 inhibitor or icatibant. A total of 45% of patients had a supply of icatibant and 56% had a supply of C1 inhibitor at home. Conclusions: Data obtained from the survey provide useful information about the demographics and treatment modalities used in HAE and acquired C1 inhibitor deficiency in the United Kingdom. These data are useful for planning service provision and improving services for these patients.
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Neonatal health care costs of very preterm babies in England: a retrospective analysis of a national birth cohortObjectives: Babies born between 27+0 and 31+6 weeks of gestation represent the largest group of very preterm babies requiring National Health Service (NHS) care; however, up-to-date, cost figures for the UK are not currently available. This study estimates neonatal costs to hospital discharge for this group of very preterm babies in England. Design: Retrospective analysis of resource use data recorded within the National Neonatal Research Database. Setting: Neonatal units in England. Patients: Babies born between 27+0 and 31+6 weeks of gestation in England and discharged from a neonatal unit between 2014 and 2018. Main outcome measures: Days receiving different levels of neonatal care were costed, along with other specialised clinical activities. Mean resource use and costs per baby are presented by gestational age at birth, along with total costs for the cohort. Results: Based on data for 28 154 very preterm babies, the annual total costs of neonatal care were estimated to be £262 million, with 96% of costs attributable to routine daily care provided by units. The mean (SD) total cost per baby of this routine care varied by gestational age at birth; £75 594 (£34 874) at 27 weeks as compared with £27 401 (£14 947) at 31 weeks. Conclusions: Neonatal healthcare costs for very preterm babies vary substantially by gestational age at birth. The findings presented here are a useful resource to stakeholders including NHS managers, clinicians, researchers and policymakers.
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Surrogate decision making in crisisCare of the critically ill newborn includes support for the birth mother/parents with regular updates around the clinical condition of the baby, and involvement in discussions around complex decision-making issues . Discussions around continuation or discontinuation of life-sustaining are challenging even in the most straightforward of cases, but what happens when the birth mother is critically unwell? Such cases can lead to uncertainty around who should assume the parental role for these difficult discussions . In this round table discussion, we explore the ethical, moral and legal uncertainties raised by coincident severe maternal and neonatal illness in the context of surrogacy.
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Reducing risks for infant mortality in the Midlands, UK: a qualitative study identifying areas for improvement in the delivery of key public health messages in the perinatal periodBackground: The Midlands has amongst the highest rates of neonatal and infant mortality in the UK. A public health parent education and empowerment programme, aimed at reducing key risks associated with this mortality was established and evaluated in the region. This was undertaken in an attempt to identify areas for optimal delivery of the public health messages around reducing risks for neonatal and infant mortality. Method: Qualitatively assessment, using the software package Dedoose®, was undertaken. This involved analysis of reflections by the programme trainers, after the delivery of their training sessions to parents, families and carers, between 01 January and 31 December 2021. These were intended to capture insights from the trainers on parent, family, carer and staff perspectives, perceptions/misperceptions around reducing risks for infant mortality. Potential areas for improvement in delivery of the programme were identified from this analysis. Results: A total of 323 programmes, comprising 524 parents, family members and carers were offered the programme. Analysis of 167 reflections around these interactions and those of staff (n = 29) are reported. The programme was positively received across parents, families, carers and staff. Four overall themes were identified: (a) reach and inclusion, (b) knowledge, (c) practical and emotional support and (d) challenges for delivery of the programme. Recommendations for improved delivery of the programme were identified, based on qualitative analysis. Conclusion: This novel approach to empowerment and education around neonatal public health messaging is a valuable tool for parents, families, carers and staff in the Midlands. Key practical recommendations for enhancing delivery of these critical public health messages were identified from this qualitative research. These are likely to be of value in other parts of the UK and globally.
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Neonatal BCG: a time for changeThe BCG vaccination programme in the UK is risk based and has usually been given to eligible babies soon after birth. On advice from the Joint Committee on Vaccination and Immunisation, NHS England and Improvement recently revised the timing of this vaccination to 28 days after birth or soon thereafter. In this article, we highlight the change in timing of vaccination, the rationale and barriers to BCG uptake that this change may pose.
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Nutrition and immunity in perinatal hypoxic-ischemic injuryPerinatal hypoxia ischaemia (PHI), acute and chronic, may be associated with considerable adverse outcomes in the foetus and neonate. The molecular and cellular mechanisms of injury and repair associated with PHI in the perinate are not completely understood. Increasing evidence is mounting for the role of nutrients and bioactive food components in immune development, function and repair in PHI. In this review, we explore current concepts around the neonatal immune response to PHI with a specific emphasis on the impact of nutrition in the mother, foetus and neonate.
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Development of a smoke-free home intervention for families of babies admitted to neonatal intensive careNeonatal intensive care units (NICUs) have a disproportionately higher number of parents who smoke tobacco compared to the general population. A baby's NICU admission offers a unique time to prompt behaviour change, and to emphasise the dangerous health risks of environmental tobacco smoke exposure to vulnerable infants. We sought to explore the views of mothers, fathers, wider family members, and healthcare professionals to develop an intervention to promote smoke-free homes, delivered on NICU. This article reports findings of a qualitative interview and focus group study with parents whose infants were in NICU (n = 42) and NICU healthcare professionals (n = 23). Thematic analysis was conducted to deductively explore aspects of intervention development including initiation, timing, components and delivery. Analysis of inductively occurring themes was also undertaken. Findings demonstrated that both parents and healthcare professionals supported the need for intervention. They felt it should be positioned around the promotion of smoke-free homes, but to achieve that end goal might incorporate direct cessation support during the NICU stay, support to stay smoke free (relapse prevention), and support and guidance for discussing smoking with family and household visitors. Qualitative analysis mapped well to an intervention based around the '3As' approach (ask, advise, act). This informed a logic model and intervention pathway.
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Induction to neonatal resuscitation: A UK-wide survey on practiceAim: To assess the perceived quality, and variation in quality, of Neonatal Induction Programmes in preparing medical staff to attend deliveries and deliver neonatal resuscitation if required. To delineate the components of an induction programme and the systems processes that would optimise medical staff training in delivering neonatal resuscitation. Methods: We conducted a nationwide (United Kingdom [UK]) survey of all junior doctors working within paediatric/neonatal posts as well as the persons responsible for organising their local Neonatal Induction Programme. Results: We received 237 respondents from diverse roles. Practitioners feel only somewhat effectively prepared to attend deliveries and deliver neonatal resuscitation. More concerningly, they report moderate-to-high levels of variation across different centres. Practical training is considered more important than theoretical; and basic topics more useful than advanced. The preferred approach to neonatal resuscitation training is a locally determined programme within a framework of national standards/recommendations. Conclusion: Practitioners feel that the quality, and particularly variation in quality, of neonatal resuscitation training at induction across the United Kingdom is suboptimal. Staff indicated the utility of a framework of national standards, and indeed this survey has been instrumental in the publication of such standards by the Royal College of Paediatrics and Child Health.
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Managerial thinking in neonatal care: a qualitative study of place of care decision-making for preterm babies born at 27-31 weeks gestation in EnglandObjectives: Preterm babies born between 27 and 31 weeks of gestation in England are usually born and cared for in either a neonatal intensive care unit or a local neonatal unit-with such units forming part of Operational Delivery Networks. As part of a national project seeking to optimise service delivery for this group of babies (OPTI-PREM), we undertook qualitative research to better understand how decisions about place of birth and care are made and operationalised. Design: Qualitative analysis of ethnographic observation data in neonatal units and semi-structured interviews with neonatal staff. Setting: Six neonatal units across two neonatal networks in England. Two were neonatal intensive care units and four were local neonatal units. Participants: Clinical staff (n=15) working in neonatal units, and people present in neonatal units during periods of observation. Results: In the context of real-world neonatal practice, with multiple (and rapidly-evolving) uncertainties relating to mothers, babies and unit/network capacity, 'best place of care' protocols were only one element of much more complex decision-making processes. Staff often made judgements from a less-than-ideal starting point, and were forced to respond to evolving clinical and organisational factors. In particular, we report that managerial considerations relating to demand and capacity organised decision-making; demand and capacity management was time-consuming and generated various pressures on families, and tensions between staff. Conclusions: Researchers and policymakers should take account of the organisational context within which place of care decisions are made. The dominance of demand and capacity management considerations is likely to limit the impact of other improvement interventions, such as initiatives to integrate families into the neonatal care provision. Demand and capacity management is an important element of neonatal care that may be overlooked, but significantly organises how care is delivered.
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Suctioning of clear amniotic fluid at birth: A systematic reviewContext: Upper airway suctioning at birth was considered standard procedure and is still commonly practiced. Negative effects could exceed benefits of suction. Question: In infants born through clear amniotic fluid (P) does suctioning of the mouth and nose (I) vs no suctioning (C) improve outcomes (O). Data sources: Information specialist conducted literature search (12th September 2021, re-run 17th June 2022) using Medline, Embase, Cochrane Databases, Database of Abstracts of Reviews of Effects, and CINAHL. RCTs, non-RCTs and observational studies with a defined selection strategy were included. Unpublished studies, reviews, editorials, animal and manikin studies were excluded. Data extraction: Two authors independently extracted data, risk of bias was assessed using the Cochrane ROB2 and ROBINS-I tools. Certainty of evidence was assed using the GRADE framework. Review Manager was used to analyse data and GRADEPro to develop summary of evidence tables. Meta-analyses were performed if ≥2 RCTs were available. Outcomes: Primary: assisted ventilation. Secondary: advanced resuscitation, oxygen supplementation, adverse effects of suctioning, unanticipated NICU admission. Results: Nine RCTs (n = 1096) and 2 observational studies (n = 418) were identified. Two RCTs (n = 280) with data concerns were excluded post-hoc. Meta-analysis of 3 RCTs, (n = 702) showed no difference in primary outcome. Two RCTs (n = 200) and 2 prospective observational studies (n = 418) found lower oxygen saturations in first 10 minutes of life with suctioning. Two RCTs (n = 200) showed suctioned newborns took longer to achieve target saturations. Limitations: Certainty of evidence was low or very low for all outcomes. Most studies selected healthy newborns limiting generalisability and insufficient data was available for planned subgroup analyses. Conclusions: Despite low certainty evidence, this review suggests no clinical benefit from suctioning clear amniotic fluid from infants following birth, with some evidence suggesting a resulting desaturation. These finding support current guideline recommendations that this practice is not used as a routine step in birth. Funding: The International Liaison Committee on Resuscitation provided access to software platforms, an information specialist and teleconferencing. Clinical trial registration: This systematic review was registered with the Prospective Register of Systematic Reviews (https://www.crd.york.ac.uk/prospero/) (identifier: CRD42021286258).