Pub Date : 2025-02-18DOI: 10.1016/S2352-4642(24)00339-0
Sabrina H Y Eliason , Anton R Miller , W Ben Gibbard , Gurpreet Salh , Nancy Lanphear
{"title":"An international response to asking difficult FASD questions – Authors' reply","authors":"Sabrina H Y Eliason , Anton R Miller , W Ben Gibbard , Gurpreet Salh , Nancy Lanphear","doi":"10.1016/S2352-4642(24)00339-0","DOIUrl":"10.1016/S2352-4642(24)00339-0","url":null,"abstract":"","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 3","pages":"Page e8"},"PeriodicalIF":19.9,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143437980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-18DOI: 10.1016/S2352-4642(24)00353-5
Prof Elizabeth Whittaker PhD , Ruchi Sinha MD , Andrew Riordan MD , Alejandra Alonso MD , Prof Marieke Emonts PhD , Stephen Owens MD , Jonathan Cohen PhD , Sarah Mahoney MD , David Porter PhD , Beatriz Larru PhD , Shelley Segal PhD , Joe Brierley MD
High consequence infectious diseases (such as Ebola virus or avian influenza) require specialist management with strict isolation to avoid spread to health-care staff and the wider community. These infections present various ethical and legal issues for children and young people. Specific challenges include the impact of isolation on the child and family (potentially without a child's consent), limitations to care due to staff safety considerations, and reduction of resources for other children (due to potential closure of paediatric intensive care unit beds). The complex decision making required in these scenarios needs timely ethical support. As planning for future pandemics accelerates, we suggest that the ethical and legal considerations involved in delivering care to affected children and their families need urgent consideration, and we have highlighted the important areas for focus to provide a route map for this important undertaking.
{"title":"Ethical and legal considerations in the care of children and young people with high consequence infectious diseases (HCIDs): an approach to decision making","authors":"Prof Elizabeth Whittaker PhD , Ruchi Sinha MD , Andrew Riordan MD , Alejandra Alonso MD , Prof Marieke Emonts PhD , Stephen Owens MD , Jonathan Cohen PhD , Sarah Mahoney MD , David Porter PhD , Beatriz Larru PhD , Shelley Segal PhD , Joe Brierley MD","doi":"10.1016/S2352-4642(24)00353-5","DOIUrl":"10.1016/S2352-4642(24)00353-5","url":null,"abstract":"<div><div>High consequence infectious diseases (such as Ebola virus or avian influenza) require specialist management with strict isolation to avoid spread to health-care staff and the wider community. These infections present various ethical and legal issues for children and young people. Specific challenges include the impact of isolation on the child and family (potentially without a child's consent), limitations to care due to staff safety considerations, and reduction of resources for other children (due to potential closure of paediatric intensive care unit beds). The complex decision making required in these scenarios needs timely ethical support. As planning for future pandemics accelerates, we suggest that the ethical and legal considerations involved in delivering care to affected children and their families need urgent consideration, and we have highlighted the important areas for focus to provide a route map for this important undertaking.</div></div>","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 3","pages":"Pages 205-210"},"PeriodicalIF":19.9,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143437849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-18DOI: 10.1016/S2352-4642(25)00033-1
Megan Tatum
{"title":"Toxic air: the biggest environmental killer of children in Europe and Central Asia","authors":"Megan Tatum","doi":"10.1016/S2352-4642(25)00033-1","DOIUrl":"10.1016/S2352-4642(25)00033-1","url":null,"abstract":"","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 3","pages":"Pages 158-159"},"PeriodicalIF":19.9,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143436548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-18DOI: 10.1016/S2352-4642(25)00008-2
Iain Hardie PhD , Louise Marryat PhD , Aja Murray PhD , Josiah King PhD , Kenneth Okelo MS , Prof James P Boardman FMedSci , Michael V Lombardo PhD , Prof Sarah J Stock PhD , Prof Rachael Wood PhD , Bonnie Auyeung PhD
Background
Understanding the effects of SARS-CoV-2 infection and COVID-19 vaccination during pregnancy can help inform clinical guidance and tackle vaccine hesitancy. We examined relationships between SARS-CoV-2 infection during pregnancy, COVID-19 vaccination during pregnancy, and early child developmental concerns in children aged 13–15 months in Scotland.
Methods
We created a large, population-level linked administrative health dataset, combining the COVID-19 in Pregnancy in Scotland (COPS) dataset with age 13–15 month child health review data and other datasets. We included children estimated to have been conceived after May 18, 2020, and born before Sept 30, 2021, and their mothers. We used logistic regression modelling to investigate associations between SARS-CoV-2 infection during pregnancy, COVID-19 vaccination during pregnancy, and developmental concerns (ie, parent or caregiver developmental concerns and health visitor-identified concerns regarding speech–language–communication, problem solving, gross motor, personal–social, and emotional–behavioural development) measured during routine child health reviews at age 13–15 months, including adjustment for confounders and covariates.
Findings
A total of 24 919 child–mother pairs (12 752 [51·2%] male children; 12 167 [48·8%] female children) were included. 1631 (6·5%) children were prenatally exposed to SARS-CoV-2 and 4943 (19·8%) to COVID-19 vaccination. We found no associations between SARS-CoV-2 infection during pregnancy and developmental concerns. After confounder and covariate adjustment, COVID-19 vaccination during pregnancy was associated with reduced odds of developmental concerns regarding problem solving (odds ratio 0·78 [95% CI 0·64–0·95]), personal–social (0·76 [0·61–0·95]), and emotional–behavioural (0·67 [0·48–0·92]) development, but had no associations with other developmental concerns.
Interpretation
SARS-CoV-2 infections during pregnancy do not appear to be linked to early childhood developmental concerns, and COVID-19 vaccinations during pregnancy appear to be safe from the perspective of early childhood developmental concerns. As some developmental concerns do not become apparent until children are older than 13–15 months, future research should continue to monitor outcomes as children grow and develop.
Funding
Economic and Social Research Council.
{"title":"Early childhood developmental concerns following SARS-CoV-2 infection and COVID-19 vaccination during pregnancy: a Scottish population-level retrospective cohort study","authors":"Iain Hardie PhD , Louise Marryat PhD , Aja Murray PhD , Josiah King PhD , Kenneth Okelo MS , Prof James P Boardman FMedSci , Michael V Lombardo PhD , Prof Sarah J Stock PhD , Prof Rachael Wood PhD , Bonnie Auyeung PhD","doi":"10.1016/S2352-4642(25)00008-2","DOIUrl":"10.1016/S2352-4642(25)00008-2","url":null,"abstract":"<div><h3>Background</h3><div>Understanding the effects of SARS-CoV-2 infection and COVID-19 vaccination during pregnancy can help inform clinical guidance and tackle vaccine hesitancy. We examined relationships between SARS-CoV-2 infection during pregnancy, COVID-19 vaccination during pregnancy, and early child developmental concerns in children aged 13–15 months in Scotland.</div></div><div><h3>Methods</h3><div>We created a large, population-level linked administrative health dataset, combining the COVID-19 in Pregnancy in Scotland (COPS) dataset with age 13–15 month child health review data and other datasets. We included children estimated to have been conceived after May 18, 2020, and born before Sept 30, 2021, and their mothers. We used logistic regression modelling to investigate associations between SARS-CoV-2 infection during pregnancy, COVID-19 vaccination during pregnancy, and developmental concerns (ie, parent or caregiver developmental concerns and health visitor-identified concerns regarding speech–language–communication, problem solving, gross motor, personal–social, and emotional–behavioural development) measured during routine child health reviews at age 13–15 months, including adjustment for confounders and covariates.</div></div><div><h3>Findings</h3><div>A total of 24 919 child–mother pairs (12 752 [51·2%] male children; 12 167 [48·8%] female children) were included. 1631 (6·5%) children were prenatally exposed to SARS-CoV-2 and 4943 (19·8%) to COVID-19 vaccination. We found no associations between SARS-CoV-2 infection during pregnancy and developmental concerns. After confounder and covariate adjustment, COVID-19 vaccination during pregnancy was associated with reduced odds of developmental concerns regarding problem solving (odds ratio 0·78 [95% CI 0·64–0·95]), personal–social (0·76 [0·61–0·95]), and emotional–behavioural (0·67 [0·48–0·92]) development, but had no associations with other developmental concerns.</div></div><div><h3>Interpretation</h3><div>SARS-CoV-2 infections during pregnancy do not appear to be linked to early childhood developmental concerns, and COVID-19 vaccinations during pregnancy appear to be safe from the perspective of early childhood developmental concerns. As some developmental concerns do not become apparent until children are older than 13–15 months, future research should continue to monitor outcomes as children grow and develop.</div></div><div><h3>Funding</h3><div>Economic and Social Research Council.</div></div>","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 3","pages":"Pages 162-171"},"PeriodicalIF":19.9,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143437846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/S2352-4642(24)00302-X
Laura Botta MSc , Fabio Didonè MSc , Angela Lopez-Cortes MSc , Adela Cañete Nieto PhD , Emmanuel Desandes MD , Lisa L Hjalgrim PhD , Zsuzsanna Jakab MD , Charles A Stiller MSc , Bernward Zeller MD , Gemma Gatta MD , Prof Kathy Pritchard-Jones PhD
<div><h3>Background</h3><div>International variation in childhood cancer survival might be explained by differences in stage at diagnosis, among other factors. As part of the BENCHISTA project, we aimed to assess geographical variation in tumour stage at diagnosis through the application, by population-based cancer registries working with clinicians, of the international consensus Toronto Childhood Cancer Stage Guidelines.</div></div><div><h3>Methods</h3><div>This population-based, retrospective cohort study involved 67 cancer registries from 23 European countries, Australia, Brazil, Japan, and Canada. Participating cancer registries applied the Toronto Guidelines to stage all incident cases of six childhood solid tumours—neuroblastoma, medulloblastoma, and Wilms tumour (age 0–14 years) and Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma (age ≤19 years)—diagnosed between Jan 1, 2014, and Dec 31, 2017. Eligible cancer registries were those able to assign stage according to the Toronto Guidelines; information on the staging investigations conducted was collected where available. European countries were grouped by geographical area and non-European countries were considered individually. We used χ<sup>2</sup> tests to compare stage distribution across these geographical areas and multivariable logistic models to estimate odds ratios (ORs) for metastatic stage at diagnosis, using central Europe (Austria, Belgium, France, Germany, the Netherlands, and Switzerland) as the comparison. Sensitivity analyses were conducted to overcome potential bias from non-random missing stage information for some geographical areas and cancer types.</div></div><div><h3>Findings</h3><div>Data from 10 937 patients with cancer (6031 [55·1%] male and 4906 [44·9%] female) were analysed. Tumour staging was complete for 93·1% (10 180 of 10 937) of patients, ranging from 88·7% (1347 of 1518 patients) with medulloblastoma to 96·5% (1083 of 1122 patients) with Ewing sarcoma. Stage distribution differed statistically by geographical area for neuroblastoma, Wilms tumour, osteosarcoma, and rhabdomyosarcoma, but not for Ewing sarcoma or medulloblastoma. After excluding patients with missing stage information and, for the sarcomas, patients aged 18–19 years, the proportions of patients with metastases detected at diagnosis were 50·3% with neuroblastoma (1435 of 2852 patients; including 1159 [40·6%] stage M and 276 [9·7%] stage MS), 35·1% with medulloblastoma (473 of 1347 patients; stages M1–M4), 32·6% with Ewing sarcoma (335 of 1028 patients), 29·0% with rhabdomyosarcoma (368 of 1267 patients), 25·5% with osteosarcoma (345 of 1353 patients), and 18·2% with Wilms tumour (384 of 2114 patients). After adjusting by age group, significant differences in the proportions of patients with metastases detected at diagnosis were found between geographical areas for neuroblastoma, Wilms tumour, osteosarcoma, and rhabdomyosarcoma.</div></div><div><h3>Interpretation</h3><div>Assessed at a populat
{"title":"International benchmarking of stage at diagnosis for six childhood solid tumours (the BENCHISTA project): a population-based, retrospective cohort study","authors":"Laura Botta MSc , Fabio Didonè MSc , Angela Lopez-Cortes MSc , Adela Cañete Nieto PhD , Emmanuel Desandes MD , Lisa L Hjalgrim PhD , Zsuzsanna Jakab MD , Charles A Stiller MSc , Bernward Zeller MD , Gemma Gatta MD , Prof Kathy Pritchard-Jones PhD","doi":"10.1016/S2352-4642(24)00302-X","DOIUrl":"10.1016/S2352-4642(24)00302-X","url":null,"abstract":"<div><h3>Background</h3><div>International variation in childhood cancer survival might be explained by differences in stage at diagnosis, among other factors. As part of the BENCHISTA project, we aimed to assess geographical variation in tumour stage at diagnosis through the application, by population-based cancer registries working with clinicians, of the international consensus Toronto Childhood Cancer Stage Guidelines.</div></div><div><h3>Methods</h3><div>This population-based, retrospective cohort study involved 67 cancer registries from 23 European countries, Australia, Brazil, Japan, and Canada. Participating cancer registries applied the Toronto Guidelines to stage all incident cases of six childhood solid tumours—neuroblastoma, medulloblastoma, and Wilms tumour (age 0–14 years) and Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma (age ≤19 years)—diagnosed between Jan 1, 2014, and Dec 31, 2017. Eligible cancer registries were those able to assign stage according to the Toronto Guidelines; information on the staging investigations conducted was collected where available. European countries were grouped by geographical area and non-European countries were considered individually. We used χ<sup>2</sup> tests to compare stage distribution across these geographical areas and multivariable logistic models to estimate odds ratios (ORs) for metastatic stage at diagnosis, using central Europe (Austria, Belgium, France, Germany, the Netherlands, and Switzerland) as the comparison. Sensitivity analyses were conducted to overcome potential bias from non-random missing stage information for some geographical areas and cancer types.</div></div><div><h3>Findings</h3><div>Data from 10 937 patients with cancer (6031 [55·1%] male and 4906 [44·9%] female) were analysed. Tumour staging was complete for 93·1% (10 180 of 10 937) of patients, ranging from 88·7% (1347 of 1518 patients) with medulloblastoma to 96·5% (1083 of 1122 patients) with Ewing sarcoma. Stage distribution differed statistically by geographical area for neuroblastoma, Wilms tumour, osteosarcoma, and rhabdomyosarcoma, but not for Ewing sarcoma or medulloblastoma. After excluding patients with missing stage information and, for the sarcomas, patients aged 18–19 years, the proportions of patients with metastases detected at diagnosis were 50·3% with neuroblastoma (1435 of 2852 patients; including 1159 [40·6%] stage M and 276 [9·7%] stage MS), 35·1% with medulloblastoma (473 of 1347 patients; stages M1–M4), 32·6% with Ewing sarcoma (335 of 1028 patients), 29·0% with rhabdomyosarcoma (368 of 1267 patients), 25·5% with osteosarcoma (345 of 1353 patients), and 18·2% with Wilms tumour (384 of 2114 patients). After adjusting by age group, significant differences in the proportions of patients with metastases detected at diagnosis were found between geographical areas for neuroblastoma, Wilms tumour, osteosarcoma, and rhabdomyosarcoma.</div></div><div><h3>Interpretation</h3><div>Assessed at a populat","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 2","pages":"Pages 89-99"},"PeriodicalIF":19.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143043986","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/S2352-4642(24)00306-7
Cherry-Ann Waldron PhD , Philip Pallmann PhD , Simon Schoenbuchner PhD , Debbie Harris PhD , Lucy Brookes-Howell PhD , Prof Céu Mateus PhD , Jolanta Bernatoniene FRCPCH PhD , Katrina Cathie FRCPCH MD , Prof Saul N Faust FRCPCH PhD , Lucy Hinds FRCPCH MBBS , Prof Kerenza Hood PhD , Chao Huang PhD , Sarah Jones BSc Hons , Sarah Kotecha PhD , Helen M Nabwera FRCPCH PhD , Sanjay Patel MRCPCH MA , Stéphane C Paulus FRCPCH MD , Prof Colin V E Powell FRCPCH MD , Jenny Preston BA Hons , Huasheng Xiang PhD , Erika Rojas-Jimenz
<div><h3>Background</h3><div>Procalcitonin is a rapid response biomarker specific for bacterial infection, which is not routinely used in the UK National Health Service. We aimed to assess whether using a procalcitonin-guided algorithm would safely reduce the duration of antibiotic therapy compared with usual care, in which C-reactive protein is the commonly used biomarker.</div></div><div><h3>Methods</h3><div>The BATCH trial was a pragmatic, multicentre, open-label, parallel, two-arm, individually randomised, controlled trial conducted in 15 hospitals in England and Wales. Children aged 72 h to 18 years who were admitted to hospital and were being treated with intravenous antibiotics for suspected or confirmed bacterial infection and who were expected to remain on intravenous antibiotics for more than 48 h were enrolled. Participants were randomly assigned (1:1) to receive either current clinical management alone (usual care group) or clinical management with the addition of a procalcitonin test guided algorithm (procalcitonin group). Participants were randomly assigned by minimisation, with site and age group (0–6 months, 6 months to 2 years, 2–5 years, and older than 5 years) as minimisation factors and a random element to reduce predictability. Participants were randomly assigned remotely using a secure 24 h web-based randomisation programme. The coprimary outcomes were duration of intravenous antibiotic use, assessed for superiority, and a composite safety measure, assessed for non-inferiority (non-inferiority margin 5%). The primary analysis sample for each coprimary endpoint included all randomly assigned participants with available outcome data. This trial is registered with the International Standard Randomised Controlled Trial Number registry, ISRCTN11369832.</div></div><div><h3>Findings</h3><div>Between June 11, 2018, and Oct 12, 2022, 15 282 children were screened for eligibility, 1949 of whom were randomly assigned to receive procalcitonin-guided antibiotic therapy (n=977) or usual care (n=972). The median intravenous antibiotic duration was 96·0 h (IQR 59·5–155·5) in the procalcitonin group and 99·7 h (61·2–153·8) in the usual care group (hazard ratio 0·96 [95% CI 0·87–1·05]). 78 (9%) of 917 participants in the procalcitonin group and 85 (9%) of 904 participants in the usual care group had at least one event covered by the composite safety outcome measure (estimated adjusted risk difference –0·81% [95% CI upper bound 1·11]).</div></div><div><h3>Interpretation</h3><div>In children with suspected or confirmed bacterial infection admitted to hospitals in England and Wales for intravenous antibiotic treatment of at least 48 h, the introduction of a procalcitonin-guided algorithm did not reduce duration of intravenous antibiotics treatment and is non-inferior to usual care for safety outcomes. Therefore, evidence does not support the use of procalcitonin-guided algorithms where robust effective paediatric antibiotic stewardship programme
背景：降钙素原是一种细菌感染特异性的快速反应生物标志物，在英国国民健康服务体系中并未常规使用。我们的目的是评估与常规护理相比，使用降钙素原引导算法是否可以安全地缩短抗生素治疗的持续时间，在常规护理中，c反应蛋白是常用的生物标志物。方法：BATCH试验是一项实用的、多中心的、开放标签的、平行的、双臂的、单独随机的、对照试验，在英格兰和威尔士的15家医院进行。年龄在72小时至18岁之间，因疑似或确诊细菌感染而入院并正在接受静脉注射抗生素治疗，预计静脉注射抗生素时间超过48小时的儿童被纳入研究对象。参与者被随机分配（1:1）接受单独的当前临床管理（常规护理组）或添加降钙素原试验指导算法的临床管理（降钙素原组）。参与者通过最小化随机分配，地点和年龄组（0-6个月，6个月至2岁，2-5岁和5岁以上）作为最小化因素和随机因素，以降低可预测性。参与者使用安全的24小时基于网络的随机程序进行远程随机分配。主要结局是静脉使用抗生素的持续时间，评估其优越性，以及综合安全性措施，评估其非劣效性（非劣效边际为5%）。每个主要终点的主要分析样本包括所有随机分配的具有可用结局数据的参与者。该试验已在国际标准随机对照试验号注册中心注册，注册号为ISRCTN11369832。结果：在2018年6月11日至2022年10月12日期间，对15282名儿童进行了资格筛选，其中1949名随机分配接受降钙素原引导的抗生素治疗（n=977）或常规护理（n=972）。降钙素原组中位静脉抗生素持续时间为96.0 h (IQR为59.5 ~ 155·5)，常规护理组中位静脉抗生素持续时间为99.7 h (IQR为61.2 ~ 153·8)（风险比为0.96 [95% CI为0.87 ~ 1.05]）。降钙素原组917名参与者中有78名（9%），常规护理组904名参与者中有85名（9%）至少有一个事件被复合安全结局测量所涵盖（估计调整后的风险差异为- 0.81% [95% CI上限1.11]）。解释：在英格兰和威尔士医院接受静脉抗生素治疗至少48小时的疑似或确诊细菌感染的儿童中，引入降钙素原引导算法并没有减少静脉抗生素治疗的持续时间，并且在安全性结果方面不低于常规护理。因此，证据不支持在建立健全有效的儿科抗生素管理规划的情况下使用降钙素原引导算法。资助：国家卫生和保健研究所。
{"title":"Procalcitonin-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection in the UK (BATCH): a pragmatic, multicentre, open-label, two-arm, individually randomised, controlled trial","authors":"Cherry-Ann Waldron PhD , Philip Pallmann PhD , Simon Schoenbuchner PhD , Debbie Harris PhD , Lucy Brookes-Howell PhD , Prof Céu Mateus PhD , Jolanta Bernatoniene FRCPCH PhD , Katrina Cathie FRCPCH MD , Prof Saul N Faust FRCPCH PhD , Lucy Hinds FRCPCH MBBS , Prof Kerenza Hood PhD , Chao Huang PhD , Sarah Jones BSc Hons , Sarah Kotecha PhD , Helen M Nabwera FRCPCH PhD , Sanjay Patel MRCPCH MA , Stéphane C Paulus FRCPCH MD , Prof Colin V E Powell FRCPCH MD , Jenny Preston BA Hons , Huasheng Xiang PhD , Erika Rojas-Jimenz","doi":"10.1016/S2352-4642(24)00306-7","DOIUrl":"10.1016/S2352-4642(24)00306-7","url":null,"abstract":"<div><h3>Background</h3><div>Procalcitonin is a rapid response biomarker specific for bacterial infection, which is not routinely used in the UK National Health Service. We aimed to assess whether using a procalcitonin-guided algorithm would safely reduce the duration of antibiotic therapy compared with usual care, in which C-reactive protein is the commonly used biomarker.</div></div><div><h3>Methods</h3><div>The BATCH trial was a pragmatic, multicentre, open-label, parallel, two-arm, individually randomised, controlled trial conducted in 15 hospitals in England and Wales. Children aged 72 h to 18 years who were admitted to hospital and were being treated with intravenous antibiotics for suspected or confirmed bacterial infection and who were expected to remain on intravenous antibiotics for more than 48 h were enrolled. Participants were randomly assigned (1:1) to receive either current clinical management alone (usual care group) or clinical management with the addition of a procalcitonin test guided algorithm (procalcitonin group). Participants were randomly assigned by minimisation, with site and age group (0–6 months, 6 months to 2 years, 2–5 years, and older than 5 years) as minimisation factors and a random element to reduce predictability. Participants were randomly assigned remotely using a secure 24 h web-based randomisation programme. The coprimary outcomes were duration of intravenous antibiotic use, assessed for superiority, and a composite safety measure, assessed for non-inferiority (non-inferiority margin 5%). The primary analysis sample for each coprimary endpoint included all randomly assigned participants with available outcome data. This trial is registered with the International Standard Randomised Controlled Trial Number registry, ISRCTN11369832.</div></div><div><h3>Findings</h3><div>Between June 11, 2018, and Oct 12, 2022, 15 282 children were screened for eligibility, 1949 of whom were randomly assigned to receive procalcitonin-guided antibiotic therapy (n=977) or usual care (n=972). The median intravenous antibiotic duration was 96·0 h (IQR 59·5–155·5) in the procalcitonin group and 99·7 h (61·2–153·8) in the usual care group (hazard ratio 0·96 [95% CI 0·87–1·05]). 78 (9%) of 917 participants in the procalcitonin group and 85 (9%) of 904 participants in the usual care group had at least one event covered by the composite safety outcome measure (estimated adjusted risk difference –0·81% [95% CI upper bound 1·11]).</div></div><div><h3>Interpretation</h3><div>In children with suspected or confirmed bacterial infection admitted to hospitals in England and Wales for intravenous antibiotic treatment of at least 48 h, the introduction of a procalcitonin-guided algorithm did not reduce duration of intravenous antibiotics treatment and is non-inferior to usual care for safety outcomes. Therefore, evidence does not support the use of procalcitonin-guided algorithms where robust effective paediatric antibiotic stewardship programme","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 2","pages":"Pages 121-130"},"PeriodicalIF":19.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142974246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/S2352-4642(24)00355-9
Josephine Holland
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