Pub Date : 2025-12-01Epub Date: 2025-10-17DOI: 10.1016/S2352-4642(25)00271-8
Prof Shalini Ojha PhD , Prof Eleanor J Mitchell PhD , Prof Mark J Johnson PhD , Prof Chris Gale PhD , Prof William McGuire MD , Sam Oddie MBBS , Sophie S Hall PhD , Garry Meakin BSc , Josie Anderson , Christopher Partlet PhD , Yuanfei Su MSc , Prof Samantha Johnson PhD , Prof Kate F Walker PhD , Reuben Ogollah PhD , Hema Mistry PhD , Seyran Naghdi PhD , Prof Alan Montgomery PhD , Prof Jon Dorling MD
<div><h3>Background</h3><div>Preterm infants typically receive intravenous fluids or parenteral nutrition while milk feeds are gradually increased. Feeding with milk sooner could reduce length of hospital stay and risk of invasive infections but might increase the risk of necrotising enterocolitis. We aimed to investigate if exclusively enteral fluids (ie, full milk feeds) from day 1 compared with gradual feeding supplemented with intravenous fluids or parenteral nutrition reduces the length of hospital stay in infants born at 30 weeks and 0 days (30<sup>+0</sup>weeks) to 32<sup>+6</sup> weeks of gestation.</div></div><div><h3>Methods</h3><div>This open-label, parallel-group, multicentre, randomised, superiority trial recruited mothers of infants born at 30<sup>+0</sup> weeks to 32<sup>+6</sup> weeks of gestation, in 46 neonatal units in UK hospitals. Infants younger than 3 h were included if they were clinically stable; those with congenital anomalies that make enteral feeding unsafe and who were small for gestational age with reversed end-diastolic flow on umbilical doppler were excluded. Parents and the clinical team could not be masked, but investigators and data analysts were masked until after database lock. The mother was randomly assigned to either full milk feeds (60–80 mL/kg per day) or gradual milk feeding (maximum of 30 mL/kg per day on day 1) with intravenous fluids or parenteral nutrition for their infant within 3 h of birth using a web-based minimisation algorithm with a random element to ensure balance on important prognostic factors. The primary outcome was length of hospital stay; events of hypoglycaemia and necrotising enterocolitis were safety outcomes and analysis was performed by intention-to-treat. This trial was prospectively registered (ISRCTN89654042) and follow-up to 24 months is ongoing.</div></div><div><h3>Findings</h3><div>Between Oct 15, 2019, and July 14, 2024, we recruited and randomly assigned 1761 mothers, enrolling 2088 infants (1047 full milk feeds, 1041 gradual feeding). Mean gestational age was 31·7 weeks (SD 0·8), which was the same in both groups, and mean birthweight was 1626·0 g (301·8) in the full milk feeds group and 1617·1 (295·2) in the gradual feeding group. Of 1047 infants in the full milk group, 494 (47·2%) were female and 552 (52·7%) were male and in 1041 infants in the gradual feeding group, 500 (48·0%) were female and 540 (51·9%) were male. Primary outcome data were missing for 18 infants in each group. We found no difference in the length of hospital stay (32·4 days [SD 13·3] in the full milk group <em>vs</em> 32·1 days [13·5] in the gradual feeding group; adjusted difference between means –0·02 days [95% CI –1·07 to 1·03]; p=0·97). Survival to discharge (1030 [99·6%] of 1034 <em>vs</em> 1027 [99·6%] of 1031; –0·004 [95% CI –0·54 to 0·53]), presence of necrotising enterocolitis (4 [0·4%] of 1030 <em>vs</em> 6 [0·6%] of 1027; –0·19 [–0·80 to 0·41]), and mean number of blood glucose tests <2·
背景：早产儿通常接受静脉输液或肠外营养，同时逐渐增加母乳喂养。尽早用牛奶喂养可以减少住院时间和侵袭性感染的风险，但可能会增加坏死性小肠结肠炎的风险。我们的目的是调查从第1天开始的纯肠内液体（即全乳喂养）与逐渐喂养补充静脉液体或肠外营养相比，是否可以减少妊娠30周和0天（30+0周）至32+6周出生的婴儿的住院时间。方法：这项开放标签、平行组、多中心、随机、优势试验在英国医院的46个新生儿病房招募了妊娠30+0周至32+6周出生婴儿的母亲。小于3小时的婴儿如果临床稳定，则纳入；排除那些有先天性异常使肠内喂养不安全的患者，以及那些胎龄较小且脐多普勒显示舒张末期血流逆转的患者。父母和临床团队无法被掩盖，但调查人员和数据分析师可以被掩盖，直到数据库锁定之后。在婴儿出生后3小时内，母亲被随机分配到全乳喂养（每天60-80毫升/公斤）或逐渐母乳喂养（第1天每天最多30毫升/公斤），并使用基于网络的最小化算法，随机元素，以确保重要预后因素的平衡。主要观察指标为住院时间；低血糖和坏死性小肠结肠炎事件是安全结果，并通过意向治疗进行分析。该试验已前瞻性注册（ISRCTN89654042），随访24个月。在2019年10月15日至2024年7月14日期间，我们招募并随机分配了1761名母亲，纳入了2088名婴儿（1047名全乳喂养，1041名渐进喂养）。平均胎龄31.7周（SD 0.8），两组差异无统计学意义；全脂喂养组平均出生体重1626.0 g(301·8)，逐渐喂养组平均出生体重1617.1 g（295·2）。全乳组1047例婴儿中，女494例（47.2%），男552例（52.7%）；渐进式喂养组1041例婴儿中，女500例（48.0%），男540例（51.9%）。每组有18名婴儿缺少主要结局数据。我们发现住院时间无差异（全脂奶组为32.4天[SD 13.3]，渐进式喂养组为32.1天[13.5]；调整后平均差为- 0.02天[95% CI - 1.07 ~ 1.03]; p= 0.97）。存活至出院（1034例中的1030例[99.6%]vs 1031例中的1027例[99.6%];- 0.004例[95% CI - 0.54 ~ 0.53]），存在坏死性小肠结肠炎（1030例中的4例[0.4%]vs 1027例中的6例[0.6%];- 0.19例[- 0.80 ~ 0.41]），平均血糖检查次数<2 mmol/L（0.6例[SD 1.0] vs 0.5例[0.7]）相似。两组婴儿的严重不良事件相似（全乳组1047例婴儿中有8例[0.8%]，逐渐喂养组1041例婴儿中有10例[1.0%]），均与试验干预无关。在妊娠30+0周至32+6周出生的婴儿中，从第1天开始全乳喂养不会改变住院时间。它不会增加坏死性小肠结肠炎或低血糖的风险。英国国家健康和护理研究所。
{"title":"Full exclusively enteral fluids from day 1 versus gradual feeding in preterm infants (FEED1): a open-label, parallel-group, multicentre, randomised, superiority trial","authors":"Prof Shalini Ojha PhD , Prof Eleanor J Mitchell PhD , Prof Mark J Johnson PhD , Prof Chris Gale PhD , Prof William McGuire MD , Sam Oddie MBBS , Sophie S Hall PhD , Garry Meakin BSc , Josie Anderson , Christopher Partlet PhD , Yuanfei Su MSc , Prof Samantha Johnson PhD , Prof Kate F Walker PhD , Reuben Ogollah PhD , Hema Mistry PhD , Seyran Naghdi PhD , Prof Alan Montgomery PhD , Prof Jon Dorling MD","doi":"10.1016/S2352-4642(25)00271-8","DOIUrl":"10.1016/S2352-4642(25)00271-8","url":null,"abstract":"<div><h3>Background</h3><div>Preterm infants typically receive intravenous fluids or parenteral nutrition while milk feeds are gradually increased. Feeding with milk sooner could reduce length of hospital stay and risk of invasive infections but might increase the risk of necrotising enterocolitis. We aimed to investigate if exclusively enteral fluids (ie, full milk feeds) from day 1 compared with gradual feeding supplemented with intravenous fluids or parenteral nutrition reduces the length of hospital stay in infants born at 30 weeks and 0 days (30<sup>+0</sup>weeks) to 32<sup>+6</sup> weeks of gestation.</div></div><div><h3>Methods</h3><div>This open-label, parallel-group, multicentre, randomised, superiority trial recruited mothers of infants born at 30<sup>+0</sup> weeks to 32<sup>+6</sup> weeks of gestation, in 46 neonatal units in UK hospitals. Infants younger than 3 h were included if they were clinically stable; those with congenital anomalies that make enteral feeding unsafe and who were small for gestational age with reversed end-diastolic flow on umbilical doppler were excluded. Parents and the clinical team could not be masked, but investigators and data analysts were masked until after database lock. The mother was randomly assigned to either full milk feeds (60–80 mL/kg per day) or gradual milk feeding (maximum of 30 mL/kg per day on day 1) with intravenous fluids or parenteral nutrition for their infant within 3 h of birth using a web-based minimisation algorithm with a random element to ensure balance on important prognostic factors. The primary outcome was length of hospital stay; events of hypoglycaemia and necrotising enterocolitis were safety outcomes and analysis was performed by intention-to-treat. This trial was prospectively registered (ISRCTN89654042) and follow-up to 24 months is ongoing.</div></div><div><h3>Findings</h3><div>Between Oct 15, 2019, and July 14, 2024, we recruited and randomly assigned 1761 mothers, enrolling 2088 infants (1047 full milk feeds, 1041 gradual feeding). Mean gestational age was 31·7 weeks (SD 0·8), which was the same in both groups, and mean birthweight was 1626·0 g (301·8) in the full milk feeds group and 1617·1 (295·2) in the gradual feeding group. Of 1047 infants in the full milk group, 494 (47·2%) were female and 552 (52·7%) were male and in 1041 infants in the gradual feeding group, 500 (48·0%) were female and 540 (51·9%) were male. Primary outcome data were missing for 18 infants in each group. We found no difference in the length of hospital stay (32·4 days [SD 13·3] in the full milk group <em>vs</em> 32·1 days [13·5] in the gradual feeding group; adjusted difference between means –0·02 days [95% CI –1·07 to 1·03]; p=0·97). Survival to discharge (1030 [99·6%] of 1034 <em>vs</em> 1027 [99·6%] of 1031; –0·004 [95% CI –0·54 to 0·53]), presence of necrotising enterocolitis (4 [0·4%] of 1030 <em>vs</em> 6 [0·6%] of 1027; –0·19 [–0·80 to 0·41]), and mean number of blood glucose tests <2·","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 12","pages":"Pages 827-836"},"PeriodicalIF":15.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145331628","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 : 2025-12-01Epub Date: 2025-11-04DOI: 10.1016/S2352-4642(25)00223-8
Winnie Wan-yee Tso MBBS , Prof Melissa M Hudson MD , Chun Sing Lam PhD , Yuliang Wang MPhil , Grace Pui Yung Tong MBBS , Ramandeep Singh Arora MBBS , Ronnie Baticulon MD , Jiaoyang Cai MD PhD , Bow-wen Chen MD , Rashmi Dalvi MD , Sanjeeva Gunasekrea MBBS , Prof Hiroki Hori MD PhD , Muhammad Saghir Khan MD , Joo-Young Kim MD PhD , Shawn Hsien Ren Lee MBBS , Lok Kan Leung MSocSc , Mora Mel MD , Shuichi Ozono MD PhD , Prof Venkatraman Radhakrishnan MD , Sudhir Sapkota MBBS , Yin Ting Cheung
Survival after childhood cancer has markedly improved over the past decades in Asia, leading to a growing number of survivors in the region. However, long-term care for these individuals remains a substantial challenge in Asia due to the insufficient availability of comprehensive childhood cancer survivorship programmes in the region. Many countries and regions of Asia are only beginning to acknowledge the significance of post-treatment care. In this third paper in a Series on childhood cancer control in Asia, we provide an overview of the challenges, disparities, and enablers in the provision of long-term follow-up care in Asia. These challenges include deficiencies in comprehensive care models that incorporate multidisciplinary approaches and insufficient support for school and social reintegration for childhood cancer survivors. To address these gaps, collaborative initiatives, such as twinning programmes and regional partnerships, can strengthen capacity and improve care delivery for low-income and lower-middle-income countries. Specific to some Asian cultures, the use of traditional complementary medicine underscores the need for further research to evaluate its efficacy in survivors. Leveraging existing networks and fostering regional collaboration will be pivotal in advancing equitable and sustainable survivorship care across the region.
{"title":"Navigating the challenges in and identifying the priorities for childhood cancer survivorship in Asia","authors":"Winnie Wan-yee Tso MBBS , Prof Melissa M Hudson MD , Chun Sing Lam PhD , Yuliang Wang MPhil , Grace Pui Yung Tong MBBS , Ramandeep Singh Arora MBBS , Ronnie Baticulon MD , Jiaoyang Cai MD PhD , Bow-wen Chen MD , Rashmi Dalvi MD , Sanjeeva Gunasekrea MBBS , Prof Hiroki Hori MD PhD , Muhammad Saghir Khan MD , Joo-Young Kim MD PhD , Shawn Hsien Ren Lee MBBS , Lok Kan Leung MSocSc , Mora Mel MD , Shuichi Ozono MD PhD , Prof Venkatraman Radhakrishnan MD , Sudhir Sapkota MBBS , Yin Ting Cheung","doi":"10.1016/S2352-4642(25)00223-8","DOIUrl":"10.1016/S2352-4642(25)00223-8","url":null,"abstract":"<div><div>Survival after childhood cancer has markedly improved over the past decades in Asia, leading to a growing number of survivors in the region. However, long-term care for these individuals remains a substantial challenge in Asia due to the insufficient availability of comprehensive childhood cancer survivorship programmes in the region. Many countries and regions of Asia are only beginning to acknowledge the significance of post-treatment care. In this third paper in a Series on childhood cancer control in Asia, we provide an overview of the challenges, disparities, and enablers in the provision of long-term follow-up care in Asia. These challenges include deficiencies in comprehensive care models that incorporate multidisciplinary approaches and insufficient support for school and social reintegration for childhood cancer survivors. To address these gaps, collaborative initiatives, such as twinning programmes and regional partnerships, can strengthen capacity and improve care delivery for low-income and lower-middle-income countries. Specific to some Asian cultures, the use of traditional complementary medicine underscores the need for further research to evaluate its efficacy in survivors. Leveraging existing networks and fostering regional collaboration will be pivotal in advancing equitable and sustainable survivorship care across the region.</div></div>","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 12","pages":"Pages 880-890"},"PeriodicalIF":15.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145435475","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 : 2025-12-01Epub Date: 2025-10-17DOI: 10.1016/S2352-4642(25)00304-9
Kate L Francis , Brett J Manley
{"title":"Clinical and statistical insights from the FEED1 trial","authors":"Kate L Francis , Brett J Manley","doi":"10.1016/S2352-4642(25)00304-9","DOIUrl":"10.1016/S2352-4642(25)00304-9","url":null,"abstract":"","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 12","pages":"Pages 818-819"},"PeriodicalIF":15.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145331629","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 : 2025-12-01Epub Date: 2025-11-04DOI: 10.1016/S2352-4642(25)00305-0
Jordan Ramnarine
{"title":"Biopolitical fractures, chronicity, and the epistemic potential of the spectral body","authors":"Jordan Ramnarine","doi":"10.1016/S2352-4642(25)00305-0","DOIUrl":"10.1016/S2352-4642(25)00305-0","url":null,"abstract":"","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 12","pages":"Pages 825-826"},"PeriodicalIF":15.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145435456","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 : 2025-12-01Epub Date: 2025-10-13DOI: 10.1016/S2352-4642(25)00219-6
Anna de Geus BSc , Prof Morris Gordon PhD , Vassiliki Sinopoulou PhD , Aderonke Ajiboye MSc , Alexander J Thornton MSc , Shiyao Liu PhD , Daniel Arruda Navarro Albuquerque MD , Prof Marc A Benninga PhD , Merit M Tabbers PhD
<div><h3>Background</h3><div>There has been a substantial increase in studies on functional constipation in children as new therapies are deployed. We aimed to provide an up-to-date, methodologically robust systematic review and meta-analysis on the efficacy and safety of pharmacological therapies for functional constipation in children.</div></div><div><h3>Methods</h3><div>In this systematic review and meta-analysis, we searched PubMed, Medline, Embase, and the Cochrane library from inception to Feb 5, 2025. We included randomised controlled trials that involved children aged 0 years to younger than 18 years with functional constipation treated with pharmacological interventions compared with placebo, no treatment, or other interventions and with at least a 2-week follow-up period. Studies were excluded if there was no definition of functional constipation, children with organic causes for constipation or previous bowel surgery were included, children with faecal incontinence without the presence of constipation were included, or the aim of treatment was faecal disimpaction rather than maintenance therapy. Pairs of authors independently extracted summary data from published reports and critiqued studies. We assessed risk of bias with the Cochrane tool. Meta-analyses estimated risk ratios (RRs) or mean differences, and 95% CIs. Certainty of evidence was established with GRADE. Our main outcomes were treatment success (as defined by study authors), defecation frequency, and withdrawals due to adverse events. This study was registered on PROSPERO (CRD42022368719).</div></div><div><h3>Findings</h3><div>Our search identified 4595 articles, of which 59 randomised controlled trials were included, representing 7045 participants with functional constipation. Interventions included polyethylene glycol (n=36 studies), lactulose (n=18), magnesium oxide or magnesium hydroxide (n=7), picosulfate (n=1), liquid paraffin (n=4), prucalopride (n=1), lubiprostone (n=2), linaclotide (n=3), plecanatide (n=1), enemas (n=2), and domperidone (n=1). Meta-analyses for treatment success showed that polyethylene glycol was probably more effective than placebo (RR 1·74 [95% CI 1·25–2·41], moderate certainty of evidence) and may be more effective than lactulose (1·35 [1·11–1·64], low certainty of evidence). There might be no difference in treatment success for linaclotide compared with placebo (1·21 [0·69–2·13], low certainty of evidence), but linaclotide probably leads to higher defecation frequency per week (mean difference 1·10 [95% CI 0·40–1·80], moderate certainty of evidence). There is low to moderate certainty evidence that prucalopride is not more effective than placebo (RR 1·68 [95% CI 0·77 to 3·68]).</div></div><div><h3>Interpretation</h3><div>Polyethylene glycol is probably more effective than placebo and key comparator therapies and should be considered the standard of first-line care. Future studies should consider polyethylene glycol as an index therapy, and cle
{"title":"Efficacy and safety of pharmacological therapies for functional constipation in children: a systematic review and meta-analysis","authors":"Anna de Geus BSc , Prof Morris Gordon PhD , Vassiliki Sinopoulou PhD , Aderonke Ajiboye MSc , Alexander J Thornton MSc , Shiyao Liu PhD , Daniel Arruda Navarro Albuquerque MD , Prof Marc A Benninga PhD , Merit M Tabbers PhD","doi":"10.1016/S2352-4642(25)00219-6","DOIUrl":"10.1016/S2352-4642(25)00219-6","url":null,"abstract":"<div><h3>Background</h3><div>There has been a substantial increase in studies on functional constipation in children as new therapies are deployed. We aimed to provide an up-to-date, methodologically robust systematic review and meta-analysis on the efficacy and safety of pharmacological therapies for functional constipation in children.</div></div><div><h3>Methods</h3><div>In this systematic review and meta-analysis, we searched PubMed, Medline, Embase, and the Cochrane library from inception to Feb 5, 2025. We included randomised controlled trials that involved children aged 0 years to younger than 18 years with functional constipation treated with pharmacological interventions compared with placebo, no treatment, or other interventions and with at least a 2-week follow-up period. Studies were excluded if there was no definition of functional constipation, children with organic causes for constipation or previous bowel surgery were included, children with faecal incontinence without the presence of constipation were included, or the aim of treatment was faecal disimpaction rather than maintenance therapy. Pairs of authors independently extracted summary data from published reports and critiqued studies. We assessed risk of bias with the Cochrane tool. Meta-analyses estimated risk ratios (RRs) or mean differences, and 95% CIs. Certainty of evidence was established with GRADE. Our main outcomes were treatment success (as defined by study authors), defecation frequency, and withdrawals due to adverse events. This study was registered on PROSPERO (CRD42022368719).</div></div><div><h3>Findings</h3><div>Our search identified 4595 articles, of which 59 randomised controlled trials were included, representing 7045 participants with functional constipation. Interventions included polyethylene glycol (n=36 studies), lactulose (n=18), magnesium oxide or magnesium hydroxide (n=7), picosulfate (n=1), liquid paraffin (n=4), prucalopride (n=1), lubiprostone (n=2), linaclotide (n=3), plecanatide (n=1), enemas (n=2), and domperidone (n=1). Meta-analyses for treatment success showed that polyethylene glycol was probably more effective than placebo (RR 1·74 [95% CI 1·25–2·41], moderate certainty of evidence) and may be more effective than lactulose (1·35 [1·11–1·64], low certainty of evidence). There might be no difference in treatment success for linaclotide compared with placebo (1·21 [0·69–2·13], low certainty of evidence), but linaclotide probably leads to higher defecation frequency per week (mean difference 1·10 [95% CI 0·40–1·80], moderate certainty of evidence). There is low to moderate certainty evidence that prucalopride is not more effective than placebo (RR 1·68 [95% CI 0·77 to 3·68]).</div></div><div><h3>Interpretation</h3><div>Polyethylene glycol is probably more effective than placebo and key comparator therapies and should be considered the standard of first-line care. Future studies should consider polyethylene glycol as an index therapy, and cle","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 12","pages":"Pages 848-856"},"PeriodicalIF":15.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145305454","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 : 2025-12-01Epub Date: 2025-11-04DOI: 10.1016/S2352-4642(25)00247-0
Alexia Sampri PhD , Wen Shi PhD , Thomas Bolton PhD , Samantha Ip PhD , Rochelle Knight MSci , Venexia Walker PhD , Rachel Denholm PhD , Elena Raffetti PhD , Spencer Keene PhD , Elias Allara MD , Xiyun Jiang MSc , Prof Evangelos Kontopantelis PhD , Prof Spiros Denaxas PhD , Prof Kamlesh Khunti FRCP , Nathalie Conrad DPhil , Christina Pagel PhD , Prof Pia Hardelid PhD , Prof Jonathan A C Sterne PhD , Prof Katherine L Brown MD , Prof William N Whiteley PhD , Prof Angela M Wood PhD
<div><h3>Background</h3><div>The rarity of severe diseases following COVID-19 infection balanced against rare COVID-19 vaccination-related adverse effects is an important consideration for vaccination policies. We aimed to assess the short-term and long-term risks of vascular and inflammatory diseases following first COVID-19 diagnosis and vaccination in children and young people.</div></div><div><h3>Methods</h3><div>In this retrospective, population-based cohort study, we analysed whole-population linked electronic health records for all individuals in England aged younger than 18 years, registered with a general practitioner, and with known age, sex, and region of residence, between Jan 1, 2020, and Dec 31, 2022. Outcomes were arterial thrombotic events, venous thrombotic events, thrombocytopenia, myocarditis or pericarditis, and inflammatory conditions. COVID-19 diagnosis was defined as the earliest record of a positive SARS-CoV-2 PCR or antigen test, or a COVID-19 diagnosis code in primary-care or secondary-care records; COVID-19 vaccination was defined as the earliest documented receipt of the BNT162b2 vaccine (the predominant vaccine during the study period). Adjusted hazard ratios (aHRs) for all outcomes were estimated by time since a first COVID-19 diagnosis during Jan 1, 2020–March 31, 2022 and by time since a first COVID-19 vaccination during Aug 6, 2021–Dec 31, 2022, adjusting for age, sex, ethnicity, region, deprivation, general practitioner contact frequency, and medication use.</div></div><div><h3>Findings</h3><div>Of 13 896 125 individuals younger than 18 years (6 784 260 [48·8%] female and 7 111 865 [51·2%] male; 9 979 420 [71·7%] White), 3 903 410 (28·1%) had a COVID-19 diagnosis. COVID-19 diagnosis (compared with no or before diagnosis) was associated with higher risk of arterial thromboembolism (aHR 2·33 [95% CI 1·20–4·51]), venous thromboembolism (4·90 [3·66–6·55]), thrombocytopenia (3·64 [2·21–6·00]), myocarditis or pericarditis (3·46 [2·06–5·80]), and inflammatory conditions (14·84 [11·01–19·99]) in the first week after diagnosis. Incidence declined in weeks 2–4, but remained elevated to beyond 12 months for venous thromboembolism (1·39 [1·14 –1·69]), thrombocytopenia (1·42 [1·01–2·00]), and myocarditis or pericarditis (1·42 [1·05–1·91]). Among 9 245 395 individuals aged between 5 and younger than 18 years who were eligible for vaccination (4 510 490 [48·8%] female and 4 734 905 [51·2%] male; 6 684 140 [72·3%] White), 3 407 560 (36·9%) received a first vaccine. COVID-19 vaccination (compared with no or before vaccination) was associated with elevated risk of myocarditis or pericarditis within the first 4 weeks after vaccination (1·84 [1·25–2·72]). The 6-month absolute excess risks for myocarditis or pericarditis were 2·24 (1·11–3·80) per 100 000 individuals after diagnosis versus before diagnosis or undiagnosed, and 0·85 (0·07–1·91) after vaccination versus before vaccination or unvaccinated.</div></div><div><h3>Interpretati
{"title":"Vascular and inflammatory diseases after COVID-19 infection and vaccination in children and young people in England: a retrospective, population-based cohort study using linked electronic health records","authors":"Alexia Sampri PhD , Wen Shi PhD , Thomas Bolton PhD , Samantha Ip PhD , Rochelle Knight MSci , Venexia Walker PhD , Rachel Denholm PhD , Elena Raffetti PhD , Spencer Keene PhD , Elias Allara MD , Xiyun Jiang MSc , Prof Evangelos Kontopantelis PhD , Prof Spiros Denaxas PhD , Prof Kamlesh Khunti FRCP , Nathalie Conrad DPhil , Christina Pagel PhD , Prof Pia Hardelid PhD , Prof Jonathan A C Sterne PhD , Prof Katherine L Brown MD , Prof William N Whiteley PhD , Prof Angela M Wood PhD","doi":"10.1016/S2352-4642(25)00247-0","DOIUrl":"10.1016/S2352-4642(25)00247-0","url":null,"abstract":"<div><h3>Background</h3><div>The rarity of severe diseases following COVID-19 infection balanced against rare COVID-19 vaccination-related adverse effects is an important consideration for vaccination policies. We aimed to assess the short-term and long-term risks of vascular and inflammatory diseases following first COVID-19 diagnosis and vaccination in children and young people.</div></div><div><h3>Methods</h3><div>In this retrospective, population-based cohort study, we analysed whole-population linked electronic health records for all individuals in England aged younger than 18 years, registered with a general practitioner, and with known age, sex, and region of residence, between Jan 1, 2020, and Dec 31, 2022. Outcomes were arterial thrombotic events, venous thrombotic events, thrombocytopenia, myocarditis or pericarditis, and inflammatory conditions. COVID-19 diagnosis was defined as the earliest record of a positive SARS-CoV-2 PCR or antigen test, or a COVID-19 diagnosis code in primary-care or secondary-care records; COVID-19 vaccination was defined as the earliest documented receipt of the BNT162b2 vaccine (the predominant vaccine during the study period). Adjusted hazard ratios (aHRs) for all outcomes were estimated by time since a first COVID-19 diagnosis during Jan 1, 2020–March 31, 2022 and by time since a first COVID-19 vaccination during Aug 6, 2021–Dec 31, 2022, adjusting for age, sex, ethnicity, region, deprivation, general practitioner contact frequency, and medication use.</div></div><div><h3>Findings</h3><div>Of 13 896 125 individuals younger than 18 years (6 784 260 [48·8%] female and 7 111 865 [51·2%] male; 9 979 420 [71·7%] White), 3 903 410 (28·1%) had a COVID-19 diagnosis. COVID-19 diagnosis (compared with no or before diagnosis) was associated with higher risk of arterial thromboembolism (aHR 2·33 [95% CI 1·20–4·51]), venous thromboembolism (4·90 [3·66–6·55]), thrombocytopenia (3·64 [2·21–6·00]), myocarditis or pericarditis (3·46 [2·06–5·80]), and inflammatory conditions (14·84 [11·01–19·99]) in the first week after diagnosis. Incidence declined in weeks 2–4, but remained elevated to beyond 12 months for venous thromboembolism (1·39 [1·14 –1·69]), thrombocytopenia (1·42 [1·01–2·00]), and myocarditis or pericarditis (1·42 [1·05–1·91]). Among 9 245 395 individuals aged between 5 and younger than 18 years who were eligible for vaccination (4 510 490 [48·8%] female and 4 734 905 [51·2%] male; 6 684 140 [72·3%] White), 3 407 560 (36·9%) received a first vaccine. COVID-19 vaccination (compared with no or before vaccination) was associated with elevated risk of myocarditis or pericarditis within the first 4 weeks after vaccination (1·84 [1·25–2·72]). The 6-month absolute excess risks for myocarditis or pericarditis were 2·24 (1·11–3·80) per 100 000 individuals after diagnosis versus before diagnosis or undiagnosed, and 0·85 (0·07–1·91) after vaccination versus before vaccination or unvaccinated.</div></div><div><h3>Interpretati","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 12","pages":"Pages 837-847"},"PeriodicalIF":15.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145435466","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}
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