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Objective: To compare two quality improvement (QI) interventions to improve antenatal magnesium sulphate (MgSO4) uptake in preterm births for the prevention of cerebral palsy. Design: Unblinded cluster randomised controlled trial. Setting: Academic Health Sciences Network, England, 2018. Sample: Maternity units with ≥10 preterm deliveries annually and MgSO4 uptake of ≤70%; 40 (27 NPP, 13 enhanced support) were included (randomisation stratified by MgSO4 uptake). Methods: The National PReCePT Programme (NPP) gave maternity units QI materials (clinical guidance, training), regional support, and midwife backfill funding. Enhanced support units received this plus extra backfill funding and unit‐level QI coaching. Main outcome measures: MgSO4 uptake was compared using routine data and multivariable linear regression. Net monetary benefit was estimated, based on implementation costs, lifetime quality‐adjusted life‐years and societal costs. The implementation process was assessed through qualitative interviews. Results: MgSO4 uptake increased in all units, with no evidence of any difference between groups (0.84 percentage points lower uptake in the enhanced group, 95% CI −5.03 to 3.35). The probability of enhanced support being cost‐effective was <30%. NPP midwives gave more than their funded hours for implementation. Units varied in their support needs. Enhanced support units reported better understanding, engagement and perinatal teamwork. Conclusions: PReCePT improved MgSO4 uptake in all maternity units. Enhanced support did not further improve uptake but may improve teamwork, and more accurately represented the time needed for implementation. Targeted enhanced support, sustainability of improvements and the possible indirect benefits of stronger teamwork associated with enhanced support should be explored further. [ABSTRACT FROM AUTHOR]

Background: A quality improvement strategy (PReCePT) was used in a standard and enhanced format to scale up a clinical intervention (administering magnesium sulphate to women in preterm labour) across all maternity units in England to protect prematurely born infants from neurodevelopmental disabilities. Formal evaluations reported the effectiveness of the standard package alone in increasing the administration of magnesium sulphate. In this paper, we focus on the findings of the process evaluations, using normalisation process theory to explain how different implementation contexts generated the observed outcomes relating to normative and relational restructuring and sustainment. Methods: Interviews were conducted with key individuals in implementation of leadership positions nationally and locally. Interviews were analysed initially using the framework method. We then engaged recursively with NPT constructs to generate generalisable insights with pragmatic applicability in other settings. Results: In total, 72 interviews were conducted with good representation from units across England and staff from the National Academic Health Science Network. We found that all units irrespective of whether they received a standard or enhanced QI package were successful in the 'normative restructuring' of their setting to enable magnesium sulphate to be administered. This suggests that this implementation outcome is necessary to achieve improvements. However, it may not be sufficient to sustain the changes once additional resources have been withdrawn. Sustainment, our findings suggest, required 'relational restructuring' to accommodate altered workflows and facilitate the sharing of responsibilities and tasks in daily practice. Relational restructuring was more likely to have been achieved units receiving enhanced QI support but also happened in units with standard QI support, especially in those where perinatal team working was already well established. Conclusion: Unlike other large QI-focused spread-and-scale programmes which failed to show any impact on outcomes, the PReCePT programme in both the enhanced and standard support packages led to improvements in the uptake of magnesium sulphate. The findings suggest that QI programmes interact with the enabling factors, such as strong interprofessional team working, already present in the setting. A standard package with minimal support was therefore sufficient in settings with enabling factors, but enhanced support was required in units where these were absent. [ABSTRACT FROM AUTHOR]

Objectives: To quantify the relative risk (RR) of childhood deaths across the whole of England during the first year of the COVID-19 pandemic, compared with a similar period of 2019.Design: This work is based on data collected by the National Child Mortality Database (NCMD). Deaths from 1 April 2020 until 31 March 2021 (2020-2021) were compared with those from the same period of 2019-2020. RR and excess mortality were derived for deaths in 2020-2021 vs 2019-2020.Setting: All deaths reported to NCMD in England of children under 18 years of age, between April 2019 and March 2021.Participants: 6490 deaths of children, under the age of 18 years, reported to the NCMD over the study period.Results: Children had similar demographics in the 2 years. There were 356 (198-514) fewer deaths in 2020-2021 than in 2019-2020 (RR 0.90 (0.85 to 0.94), p<0.001). Deaths from infection (RR 0.49 (0.38 to 0.64)) and from other underlying medical conditions (RR 0.75 (0.68 to 0.82)) were lower in 2020-2021 than 2019-2020, and weak evidence (RR 0.50 (0.23 to 1.07), p=0.074) that this was also true of deaths from substance abuse.Conclusions: Childhood mortality in England during the first year of the SARS-CoV-2 pandemic was lower than expected, with over 300 fewer deaths than the preceding 12 months. The greatest reduction was in children less than 10 years old. It is important that we learn from this effect that potentially offers alternative ways to improve the outcome for the most vulnerable children in our society. [ABSTRACT FROM AUTHOR]

Objectives Using the National Child Mortality Database (NCMD), this work aims to investigate and quantify the characteristics of children dying of COVID-19, and to identify any changes in rate of childhood mortality during the pandemic. Design We compared the characteristics of the children who died in 2020, split by SARS-CoV-2 status. A negative binomial regression model was used to compare mortality rates in lockdown (23 March-28 June), with those children who died in the preceding period (6 January-22 March), as well as a comparable period in 2019. Setting England. Participants Children (0-17 years). Main outcome measures Characteristics and number of the children who died in 2020, split by SARS-CoV-2 status. Results 1550 deaths of children between 6th of January and 28 June 2020 were notified to the NCMD; 437 of the deaths were linked to SARS-CoV-2 virology records, 25 (5.7%) had a positive PCR result. PCR-positive children were less likely to be white (37.5% vs 69.4%, p=0.003) and were older (12.2 vs 0.7 years, p<0.0006) compared with child deaths without evidence of the virus. All-cause mortality rates were similar during lockdown compared with both the period before lockdown in 2020 (rate ratio (RR) 0.93 (0.84 to 1.02)) and a similar period in 2019 (RR 1.02 (0.92 to 1.13)). Conclusions There is little to suggest that there has been excess mortality during the period of lockdown. The apparent higher frequency of SARS-CoV-2-positive tests among children from black, Asian and minority ethnic groups is consistent with findings in adults. Ongoing surveillance is essential as the pandemic continues. [ABSTRACT FROM AUTHOR]

Following low incidence of invasive group A streptococcal (iGAS) infections during the COVID-19 pandemic, marked increases were noted in many countries during 2022, particularly in children. In November 2022, severe presentations of lower respiratory tract infections (LRTIs), including empyema, were notified by clinicians across the UK. UKHSA investigated this rise with the aim of informing clinical management and public health response. We undertook a case-series analysis using multiple routine data sources, exempted from ethics approval or patient consent. We identified iGAS cases in England in children younger than 15 years with an LRTI reported between Oct 1 and Dec 21, 2022, using UKHSA laboratory surveillance data (GAS detected in LRT specimens) and notifications by clinicians and Health Protection Teams (HPTs). Symptoms, diagnoses, health-care interactions, and outcome (death or recovery) data were obtained from HPT case management notes, the National Child Mortality Database, and the NHS Digital Emergency Care Dataset. We identified 147 cases of LRTI iGAS in children across England (77 [52%] male, 70 [48%] female; median age 4 years [IQR 2–6]). Predominant ethnicities were White (74 [65%] of 113 with known ethnicity) and Asian (18 [16%] of 113). Most reported symptoms were fever (90 [75%] of 120 children with ≥1 symptom) and cough (60 [50%] of 120), and 71 (48%) of all 147 children had a diagnosed respiratory viral coinfection (most commonly hMPV and RSV). 127 (86%) of children attended an emergency department, 31% (n=36/114 with onset date) at least twice within 21 days after symptom onset. 37 (25%) of 147 children died, with a median time from symptom onset to death of 4 days (IQR 3–7). Of 32 children with sample dates, 16 (84%) were tested for GAS on or after the day they died. Over half of deaths (21 [57%] of 37 deaths) occurred in the community after rapid deterioration, of whom 18 had previous contact with health-care services documented. The UK saw an unusual rise in iGAS LRTIs in children in late 2022. One in four cases died, over half in the community. Non-specific symptoms, viral symptoms, or positive virology might have lowered suspicion of bacterial infection. Although the use of multiple available data sources expedited the analysis, varying data completeness limited interpretation. Our study highlights the need for earlier detection and identification of effective measures to prevent death. None. [ABSTRACT FROM AUTHOR]

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Importance: Although the immediate impact of neonatal illness is well recognized, its wider and longer term outcomes on childhood mortality and the role of specific illnesses across childhood are unclear., Objective: To investigate how many deaths in childhood are associated with neonatal illness and the underlying conditions of the children who died., Design, Setting, and Participants: This population-based cohort study of children who died before age 10 years in England between April 1, 2019, and March 31, 2021, used data from the National Child Mortality Database. Data analysis was performed from September 2022 to May 2023., Exposure: Children who received care in a neonatal unit after birth plus those who died in the first day of life, before admission to a neonatal unit, were considered to have likely neonatal illness., Main Outcomes and Measures: The primary outcome was the relative risk (RR) of dying, stratified by likely neonatal illness and specific neonatal conditions. Comparisons were made using the χ2 or likelihood ratio test, as appropriate., Results: A total of 4829 children were included (median [IQR] age at death, 28 [2-274] days; 2606 boys [54.8%]; 2690 White children [64.0%]). Overall, 3456 children who died (71.6%) had evidence of likely neonatal illness. Children with neonatal illness were more likely to die before their tenth birthday than those without evidence of neonatal illness (RR, 13.82; 95% CI, 13.00-14.71). The estimated population-attributable risk fraction for neonatal illness among all deaths before age 10 years was 66.4% (95% CI, 64.9%-67.9%). Children with preceding neonatal illness who died were more likely to have underlying behavioral or developmental disorders (odds ratio [OR], 3.31; 95% CI, 2.47-4.42), chronic neurological disease (OR, 3.00; 95% CI, 2.51-3.58), and chronic respiratory disease (OR, 3.01; 95% CI, 2.43-3.73) than children without neonatal illness., Conclusions and Relevance: In this cohort study, most children who died before age 10 years had some evidence of neonatal illness, and they died of a range of causes, including infections and sudden, unexpected, unexplained death. These findings suggest that improvements to perinatal morbidity, an area with an existing evidence base for improvement, may have important impacts on child health across the next decade.

Objective: To evaluate the effectiveness and cost-effectiveness of the National PReCePT Programme (NPP) in increasing use of magnesium sulfate (MgSO 4 ) in preterm births., Design: Before-and-after study., Setting: Maternity units (N=137) within NHS England and the Academic Health Science Network (AHSN) in 2018., Participants: Babies born ≤30 weeks' gestation admitted to neonatal units in England., Interventions: The NPP was a quality improvement (QI) intervention including the PReCePT (Preventing Cerebral Palsy in Pre Term labour) QI toolkit and materials (preterm labour proforma, staff training presentations, parent leaflet, posters for the unit and learning log), regional AHSN-level support, and up to 90 hours funded backfill for a midwife 'champion' to lead implementation., Main Outcome Measures: MgSO 4 uptake post implementation was compared with pre-NPP implementation uptake. Implementation and lifetime costs were estimated., Results: Compared with pre-implementation estimates, the average MgSO 4 uptake for babies born ≤30 weeks' gestation, in 137 maternity units in England, increased by 6.3 percentage points (95% CI 2.6 to 10.0 percentage points) to 83.1% post implementation, accounting for unit size, maternal, baby and maternity unit factors, time trends, and AHSN. Further adjustment for early/late initiation of NPP activities increased the estimate to 9.5 percentage points (95% CI 4.3 to 14.7 percentage points). From a societal and lifetime perspective, the health gains and cost savings associated with the NPP effectiveness generated a net monetary benefit of £866 per preterm baby and the probability of the NPP being cost-effective was greater than 95%., Conclusion: This national QI programme was effective and cost-effective. National programmes delivered via coordinated regional clinical networks can accelerate uptake of evidence-based therapies in perinatal care., Competing Interests: Competing interests: GAF received grant funding from the NIHR and the British Heart Foundation and is a party to partnership agreements with industry partners as CEO of the Oxford Academic Health Science Network. He is chair of the Buckinghamshire, Oxfordshire and West Berkshire Integrated Stroke Delivery Network, the Academic Health Science Network, the European Stroke Organisation Council of Fellows and the Academy of Medical Sciences Fellowship Sectional Committee 7. He is Director of the Cogentis and Accelerate companies and Non-Executive Director of the National Institute for Health and Care Excellence, and serves on the Board of Trustees of the Picker Institute and Health Services Research UK, and the governing body of Green Templeton College, Oxford University. He is data monitoring committee member for the PREVENT-SVD study, trial steering group member for OPTIMAS, R4VaD, ATTEST-2 and SENIOR-RITA trials, grants review panel member for Pfizer/Bristol Myers Squibb, and round table member for the Bristol Myers Squibb/Price Waterhouse Cooper Life Sciences 2030 Cancer Moonshot and Astellas Company Conference. KT acted as expert witness to the High Court in England, called by the UK MHRA, defendant in a case on hormonal pregnancy tests and congenital anomalies in 2021/2022. All other authors in this manuscript have no conflict of interest to declare aside from funding from NIHR ARC West, AHSN, NHS England and Health Foundation. The authors declare that the study management group has no competing financial, professional or personal interests that might have influenced the study design or conduct., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Importance: During the first year of the COVID-19 pandemic, child mortality in England was the lowest on record, but if this trend will continue, or if unrecognized morbidity during the first year of the pandemic will manifest as increased deaths over the next few years is unclear., Objective: To examine the risks and patterns of childhood deaths before and during the COVID-19 pandemic., Design, Setting, and Participants: This population-based cohort study includes all child deaths in England from April 1, 2019, to March 31, 2022., Exposures: The year of death., Main Outcomes and Measures: The primary outcome measure is risk of death., Results: Of the 9983 child deaths reported during the study period, 9872 (98.8%) were linked to demographic and population data with 3409 deaths (34.5%) between April 2019 and March 2020, 3035 (30.7%) between April 2020 and March 2021, and 3428 (34.7%) between April 2021 and March 2022. Most deaths occurred in children who were younger than 1 year (6257 of 9872 [62.7%]), the majority were male (5534 of 9760 [56.7%]), and lived in an urban area (8766 of 9872 [88.8%]). The risk of death was lower between April 2020 and March 2021 (relative risk [RR], 0.89 [95% CI, 0.84-0.93]), but not between April 2021 and March 2022 (RR, 1.00 [95% CI, 0.95-1.05]) when compared with April 2019 to March 2020. A population attributable risk (PAF) of 4.0% (95% CI, 0.1%-6.8%) suggested fewer deaths occurred during the whole 3-year period than expected. Reductions were seen in risk of dying by infection (PAF, 22.8% [95% CI, 8.2%-37.0%]) and underlying disease (PAF, 13.3% [95% CI, 8.1%-18.8%]), but there was evidence of an increasing risk of death by trauma (PAF, 14.7% [95% CI, 2.9%-25.2%]). Any reduction in the risk of death was greater in rural areas than in urban areas (RR, 0.73 [95% CI, 0.63-0.85] vs RR, 0.91 [95% CI, 0.86-0.95]) and was not seen in children older than 9 years., Conclusions and Relevance: In this cohort study, there was a significant reduction in all-cause child mortality during the first year of the COVID-19 pandemic (2020-2021), which returned to close to prepandemic levels the following year (2021-2022). However, there was a net reduction in deaths despite this, with 4% fewer deaths during the 3-year period than would have been expected from the 2019 to 2020 risks. The reductions were largest in rural areas and in children younger than 10 years.

Objectives: The aim of this analysis is to identify the patterns of social deprivation and childhood mortality; and identify potential points where public health, social and education interventions, or health policy may be best targeted., Design: Decile of deprivation and underlying population distribution was derived using Office for National Statistics data. The risk of death was then derived using a Poisson regression model, calculating the increasing risk of death for each increasing deprivation decile., Setting: England., Participants: 2688 deaths before 18 years of age reviewed between April 2019 and March 2020., Main Outcome Measures: The relationship between deprivation and risk of death; for deaths with, and without modifiable factors., Results: There was evidence of increasing mortality risk with increase in deprivation decile, with children in the least deprived areas having a mortality of 13.25 (11.78-14.86) per 100 000 person-years, compared with 31.14 (29.13-33.25) in the most deprived decile (RR 1.08 (95% CI 1.07 to 1.10)); with the gradient of risk stronger in children who died with modifiable factors than those without (RR 1.12 (95% CI 1.09 to 1.15)) vs (RR 1.07 (95% CI 1.05 to 1.08)). Deprivation subdomains of employment, adult education, barriers to housing and services, and indoor living environments appeared to be the most important predictors of child mortality CONCLUSIONS: There is a clear gradient of increasing child mortality across England as measures of deprivation increase; with a striking finding that this varied little by area, age or other demographic factor. Over one-fifth of all child deaths may be avoided if the most deprived half of the population had the same mortality as the least deprived. Children dying in more deprived areas may have a greater proportion of avoidable deaths. Adult employment, and improvements to housing, may be the most efficient place to target resources to reduce these inequalities., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Perinatal Excellence to Reduce Injury in Premature Birth (PERIPrem) is an 11-element perinatal care bundle designed to improve outcomes for preterm babies, in line with the National Health Service (NHS) Long Term plan. Designed in collaboration with 12 NHS Trusts (secondary care hospitals), South West and West of England Academic Health Science Networks, South West Neonatal Operational Delivery Network, parent partners and clinical experts, implementation was via bespoke quality improvement (QI) methodology. Before project initiation, there was regional variation in uptake of elements, evidenced by baseline audit. Optimisation of the preterm infant is complex; eligibility for treatments is dependent on gestation and local policies. Preterm infants experience variability in care dependent on the place of birth, and there remains an implementation gap for several effective, evidence-based treatments.The PERIPrem ambition is to reduce severe brain injury and death caused by prematurity by at least 50% through the delivery of a perinatal care bundle. The PERIPrem approach resulted in improved element implementation by 26% (from 3% to 29%) between 2019 and 2021, with dyads significantly more likely to receive the full bundle in 2021 compared with 2019 (probability=0.96 (95% CI 0.87 to 0.99), p<0.001). When examining the impact on psychological safety and team-working of PERIPrem, linear mixed models indicated an improvement in team function (p=0.021), situation monitoring (p=0.029) and communication within teams (p=0.002). Central to success was the development of a committed multiorganisational collaborative that continues to drive perinatal improvement using a common language and streamlining processes. In addition to saving the lives of the most vulnerable babies, PERIPrem aims to improve the chances of disability-free lives and is successfully nurturing high-functioning perinatal teams with enhanced QI skills., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is rarely fatal in children and young people (CYP, <18 years old), but quantifying the risk of death is challenging because CYP are often infected with SARS-CoV-2 exhibiting no or minimal symptoms. To distinguish between CYP who died as a result of SARS-CoV-2 infection and those who died of another cause but were coincidentally infected with the virus, we undertook a clinical review of all CYP deaths with a positive SARS-CoV-2 test from March 2020 to February 2021. The predominant SARS-CoV-2 variants were wild-type and Alpha. Here we show that, of 12,023,568 CYP living in England, 3,105 died, including 61 who were positive for SARS-CoV-2. Of these deaths, 25 were due to SARS-CoV-2 infection (mortality rate, two per million), including 22 due to coronavirus disease 2019-the clinical disease associated with SARS-CoV-2 infection-and 3 were due to pediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2. In total, 99.995% of CYP with a positive SARS-CoV-2 test survived. CYP older than 10 years, Asian and Black ethnic backgrounds and comorbidities were over-represented in SARS-CoV-2-related deaths compared with other CYP deaths. These results are important for guiding decisions on shielding and vaccinating children. New variants might have different mortality risks and should be evaluated in a similar way., (© 2021. The Author(s), under exclusive licence to Springer Nature America, Inc.)

Identifying which children and young people (CYP) are most vulnerable to serious infection due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is important to guide protective interventions. To address this question, we used data for all hospitalizations in England among 0-17 year olds from 1 February 2019 to 31 January 2021. We examined how sociodemographic factors and comorbidities might be risk factors for pediatric intensive care unit (PICU) admission among hospitalizations due to the following causes: Coronavirus Disease 2019 (COVID-19) and pediatric inflammatory multi-system syndrome temporally associated with SARS-CoV-2 (PIMS-TS) in the first pandemic year (2020-2021); hospitalizations due to all other non-traumatic causes in 2020-2021; hospitalizations due to all non-traumatic causes in 2019-2020; and hospitalizations due to influenza in 2019-2020. Risk of PICU admission and death from COVID-19 or PIMS-TS in CYP was very low. We identified 6,338 hospitalizations with COVID-19, of which 259 were admitted to a PICU and eight CYP died. We identified 712 hospitalizations with PIMS-TS, of which 312 were admitted to a PICU and fewer than five CYP died. Hospitalizations with COVID-19 and PIMS-TS were more common among males, older CYP, those from socioeconomically deprived neighborhoods and those who were of non-White ethnicity (Black, Asian, Mixed or Other). The odds of PICU admission were increased in CYP younger than 1 month old and decreased among 15-17 year olds compared to 1-4 year olds with COVID-19; increased in older CYP and females with PIMS-TS; and increased for Black compared to White ethnicity in patients with COVID-19 and PIMS-TS. Odds of PICU admission in COVID-19 were increased for CYP with comorbidities and highest for CYP with multiple medical problems. Increases in odds of PICU admission associated with different comorbidities in COVID-19 showed a similar pattern to other causes of hospitalization examined and, thus, likely reflect background vulnerabilities. These findings identify distinct risk factors associated with PICU admission among CYP with COVID-19 or PIMS-TS that might aid treatment and prevention strategies., (© 2021. The Author(s), under exclusive licence to Springer Nature America, Inc.)

The UK's National Institute for Health and Care Excellence Preterm labour and birth guideline recommends use of magnesium sulfate (MgSO 4 ) in deliveries below 30 weeks' gestation to prevent cerebral palsy and other neurological problems associated with preterm delivery. Despite national guidance, the uptake of MgSO 4 administration in eligible women has been slow. National Health Service England has rolled out the PReCePT (PRevention of Cerebral Palsy in Pre-Term labour) quality improvement (QI) toolkit to increase uptake of MgSO 4 in preterm deliveries. The toolkit is designed to increase maternity staff knowledge about MgSO 4 and provides training and practical tools to help staff consider use in eligible women. The PReCePT trial compares the effectiveness of two different methods of implementing the QI toolkit (standard versus enhanced support). The standard support arm (control) receives the QI toolkit and regional-level support for a midwife/obstetric 'champion'. The enhanced support arm (intervention) receives this plus additional clinical backfill funding and unit-level QI microcoaching. It is funded by The Health Foundation. This is a cluster randomised controlled trial designed to include 48 maternity units randomised (2:1 ratio) to standard or enhanced support. Units are eligible for inclusion if they have 10 or more preterm (<30 weeks' gestation) deliveries annually and MgSO 4 uptake of 70% or less. Randomisation is stratified by previous level of MgSO 4 uptake. The QI intervention is implemented over 9 months. All units are followed up for a further 9 months. Blinding is not possible due to the nature of the intervention. The primary outcome is the proportion of MgSO 4 uptake among eligible women at follow-up, adjusting for uptake before implementation of the toolkit. The effectiveness of the intervention will be assessed using weighted linear regression on data from the National Neonatal Research Database. Semistructured qualitative staff interviews will inform understanding of the process and outcomes. Economic evaluation will describe total costs and cost-effectiveness. Trial registration number SRCTN 40938673., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)