Pub Date : 2025-11-04DOI: 10.1016/S2352-4642(25)00305-0
Jordan Ramnarine
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Pub 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
Background
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.
Methods
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.
Findings
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.
{"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":"2025-11-04","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}
Pub Date : 2025-11-04DOI: 10.1016/S2352-4642(25)00243-3
Samira Saberian MSc , Prof Chris Gale MBBS PhD , Nimish Subhedar MD FRCPCH , Natalie Gallagher MBChB , Oluwaseun B Esan DPhil , Prof Ian Sinha MBBS PhD , Kelly Harvey MSc , Daniela K Schlüter PhD , Prof David Taylor-Robinson MBChBPhD
Background
Babies born to mothers living in more deprived areas and from ethnic minority groups are at a higher risk of dying during the neonatal period. Preterm and unwell term babies are cared for in neonatal units, and this population contributes substantially to the child mortality rate. The extent of and reasons for socioeconomic and ethnic inequalities in neonatal unit outcomes are unclear. We aimed to evaluate socioeconomic and ethnic inequalities in characteristics and mortality of babies admitted to National Health Service (NHS) neonatal units in England and Wales.
Methods
In this retrospective cohort study, any baby that was born at or after 22 weeks’ gestation and admitted to an NHS neonatal unit in England and Wales, received neonatal care, and had clinical data registered in the National Neonatal Research Database was eligible for inclusion. Our primary exposures of interest were index of multiple deprivation (IMD) and maternal ethnicity. We assessed inequalities in in-unit mortality before discharge using nested logistic regression models, estimating crude, confounder-adjusted, and case-mix adjusted odds of mortality. Case-mix variables on admission were gestational age, birthweight, sex, maternal age, smoking during pregnancy, the presence of any congenital anomaly, obstetric problem, and previous medical problem in the mother.
Findings
Between Jan 1, 2012, and Dec 31, 2022, 709 569 babies were included in the analysis and there were 11 257 (1·6%) neonatal unit deaths. Of the 678 550 babies with complete IMD information, 649 180 (95·7%) babies were born to mothers living in England and 29 308 (4·3%) to mothers living in Wales. 561 621 (79·1%) babies had complete information on exposures and case-mix variables on admission used for logistic regression. More babies in neonatal units were born to women from the most deprived decile (102 419 [15·1%]) compared with the least deprived decile (43 882 [6·5%]). Babies born to women from the most deprived decile were at increased risk of mortality (odds ratio [OR] 1·63 [95% CI 1·48–1·81]) than babies born to women from the least deprived decile. After adjusting for ethnicity, the OR was 1·52 (1·38–1·69), and after adjusting for case-mix, the OR was 1·23 (1·10–1·37). Babies born to mothers who were Black had an OR for mortality of 1·81 (1·67–1·95) compared with mothers who were White, attenuated to 1·68 (1·55–1·81) after adjusting for deprivation, and 1·14 (1·05–1·24) in the case-mix adjusted model. Babies born to mothers who were Asian had an OR for mortality of 1·48 (1·39–1·57) compared with mothers who were White, attenuated to 1·40 (1·32–1·49) after adjusting for deprivation, and 1·36 (1·27–1·45) in the case-mix adjusted model.
Interpretation
There are stark socioeconomic and ethnic inequalities in babies admitted to and who die in neonatal units in England and Wales. Mortality inequal
{"title":"Inequalities in neonatal unit mortality in England and Wales between 2012 and 2022: a retrospective cohort study","authors":"Samira Saberian MSc , Prof Chris Gale MBBS PhD , Nimish Subhedar MD FRCPCH , Natalie Gallagher MBChB , Oluwaseun B Esan DPhil , Prof Ian Sinha MBBS PhD , Kelly Harvey MSc , Daniela K Schlüter PhD , Prof David Taylor-Robinson MBChBPhD","doi":"10.1016/S2352-4642(25)00243-3","DOIUrl":"10.1016/S2352-4642(25)00243-3","url":null,"abstract":"<div><h3>Background</h3><div>Babies born to mothers living in more deprived areas and from ethnic minority groups are at a higher risk of dying during the neonatal period. Preterm and unwell term babies are cared for in neonatal units, and this population contributes substantially to the child mortality rate. The extent of and reasons for socioeconomic and ethnic inequalities in neonatal unit outcomes are unclear. We aimed to evaluate socioeconomic and ethnic inequalities in characteristics and mortality of babies admitted to National Health Service (NHS) neonatal units in England and Wales.</div></div><div><h3>Methods</h3><div>In this retrospective cohort study, any baby that was born at or after 22 weeks’ gestation and admitted to an NHS neonatal unit in England and Wales, received neonatal care, and had clinical data registered in the National Neonatal Research Database was eligible for inclusion. Our primary exposures of interest were index of multiple deprivation (IMD) and maternal ethnicity. We assessed inequalities in in-unit mortality before discharge using nested logistic regression models, estimating crude, confounder-adjusted, and case-mix adjusted odds of mortality. Case-mix variables on admission were gestational age, birthweight, sex, maternal age, smoking during pregnancy, the presence of any congenital anomaly, obstetric problem, and previous medical problem in the mother.</div></div><div><h3>Findings</h3><div>Between Jan 1, 2012, and Dec 31, 2022, 709 569 babies were included in the analysis and there were 11 257 (1·6%) neonatal unit deaths. Of the 678 550 babies with complete IMD information, 649 180 (95·7%) babies were born to mothers living in England and 29 308 (4·3%) to mothers living in Wales. 561 621 (79·1%) babies had complete information on exposures and case-mix variables on admission used for logistic regression. More babies in neonatal units were born to women from the most deprived decile (102 419 [15·1%]) compared with the least deprived decile (43 882 [6·5%]). Babies born to women from the most deprived decile were at increased risk of mortality (odds ratio [OR] 1·63 [95% CI 1·48–1·81]) than babies born to women from the least deprived decile. After adjusting for ethnicity, the OR was 1·52 (1·38–1·69), and after adjusting for case-mix, the OR was 1·23 (1·10–1·37). Babies born to mothers who were Black had an OR for mortality of 1·81 (1·67–1·95) compared with mothers who were White, attenuated to 1·68 (1·55–1·81) after adjusting for deprivation, and 1·14 (1·05–1·24) in the case-mix adjusted model. Babies born to mothers who were Asian had an OR for mortality of 1·48 (1·39–1·57) compared with mothers who were White, attenuated to 1·40 (1·32–1·49) after adjusting for deprivation, and 1·36 (1·27–1·45) in the case-mix adjusted model.</div></div><div><h3>Interpretation</h3><div>There are stark socioeconomic and ethnic inequalities in babies admitted to and who die in neonatal units in England and Wales. Mortality inequal","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 12","pages":"Pages 857-867"},"PeriodicalIF":15.5,"publicationDate":"2025-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145435468","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 : 2025-11-04DOI: 10.1016/S2352-4642(25)00222-6
Paige Terrien Church MD , Rudaina Banihani MD , Amy Rule MD , David Frumberg MD , John Maypole MD , Prof Ashley Volion PhD , Prof Michael Msall MD , Prof Peter Rosenbaum MD
In the field of paediatrics, the concept of normal (ie, typical)—in contrast to different, special, deviant, delayed, or atypical—has imposed a problematic framework within which people view a child with an impairment. This binary perspective oversimplifies a complex, fluid, and dynamic process encompassing physical, behavioural, emotional, cognitive, social, and communicative development. Furthermore, this approach reinforces the notion of a singular normality, diminishing the value of any variation from this assumed (and usually poorly defined and naive) standard, in a way that speaks of ableism—the normative bias that a standard norm exists and anything other than this standard is inferior. Ableism profoundly affects systems, whether they be clinical or medical, educational, or community-based or research-based. The aims of this Personal View are to (1) examine the evolution of disability definitions; (2) challenge the construct of normal in child health; and (3) review identified types of disability. This Personal View explores the literature on ableism in paediatrics from a global perspective, assessing its effect on children, their parents and families, and on the broader community. We offer a modern perspective on disability, embracing the resilience and adaptations that often emerge, while acknowledging challenges. We aim to provide paediatric learners and health-care professionals with opportunities to improve paediatric care through an inclusionary, strengths-based approach to disability that values diverse developmental pathways and challenges rigid normative expectations.
{"title":"Impaired expectations: the challenge of ableism in paediatrics","authors":"Paige Terrien Church MD , Rudaina Banihani MD , Amy Rule MD , David Frumberg MD , John Maypole MD , Prof Ashley Volion PhD , Prof Michael Msall MD , Prof Peter Rosenbaum MD","doi":"10.1016/S2352-4642(25)00222-6","DOIUrl":"10.1016/S2352-4642(25)00222-6","url":null,"abstract":"<div><div>In the field of paediatrics, the concept of normal (ie, typical)—in contrast to different, special, deviant, delayed, or atypical—has imposed a problematic framework within which people view a child with an impairment. This binary perspective oversimplifies a complex, fluid, and dynamic process encompassing physical, behavioural, emotional, cognitive, social, and communicative development. Furthermore, this approach reinforces the notion of a singular normality, diminishing the value of any variation from this assumed (and usually poorly defined and naive) standard, in a way that speaks of ableism—the normative bias that a standard norm exists and anything other than this standard is inferior. Ableism profoundly affects systems, whether they be clinical or medical, educational, or community-based or research-based. The aims of this Personal View are to (1) examine the evolution of disability definitions; (2) challenge the construct of normal in child health; and (3) review identified types of disability. This Personal View explores the literature on ableism in paediatrics from a global perspective, assessing its effect on children, their parents and families, and on the broader community. We offer a modern perspective on disability, embracing the resilience and adaptations that often emerge, while acknowledging challenges. We aim to provide paediatric learners and health-care professionals with opportunities to improve paediatric care through an inclusionary, strengths-based approach to disability that values diverse developmental pathways and challenges rigid normative expectations.</div></div>","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"10 1","pages":"Pages 62-70"},"PeriodicalIF":15.5,"publicationDate":"2025-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145441948","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 : 2025-11-04DOI: 10.1016/S2352-4642(25)00269-X
Lisa M Force , Asim F Belgaumi
{"title":"Building momentum to improve childhood cancer outcomes in Asia","authors":"Lisa M Force , Asim F Belgaumi","doi":"10.1016/S2352-4642(25)00269-X","DOIUrl":"10.1016/S2352-4642(25)00269-X","url":null,"abstract":"","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 12","pages":"Pages 819-820"},"PeriodicalIF":15.5,"publicationDate":"2025-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145435458","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 : 2025-10-17DOI: 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。
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Pub 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":"2025-10-17","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}
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