Pub Date : 2026-02-10DOI: 10.1016/S2352-4642(26)00015-5
The Lancet Child & Adolescent Health Editors
{"title":"Thank you to The Lancet Child & Adolescent Health statistical and peer reviewers in 2025","authors":"The Lancet Child & Adolescent Health Editors","doi":"10.1016/S2352-4642(26)00015-5","DOIUrl":"10.1016/S2352-4642(26)00015-5","url":null,"abstract":"","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"10 3","pages":"Pages e10-e13"},"PeriodicalIF":15.5,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146147430","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 : 2026-02-10DOI: 10.1016/S2352-4642(26)00013-1
Michelle Meiring , Lorna Fraser
{"title":"Suffer the little children: measuring the global need for paediatric palliative care","authors":"Michelle Meiring , Lorna Fraser","doi":"10.1016/S2352-4642(26)00013-1","DOIUrl":"10.1016/S2352-4642(26)00013-1","url":null,"abstract":"","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"10 3","pages":"Pages 149-150"},"PeriodicalIF":15.5,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146147458","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 : 2026-02-10DOI: 10.1016/S2352-4642(25)00351-7
Axel R Franz MD , Christian A Maiwald , Hendrik J Niemarkt PhD , Prof Harald Ehrhardt MD , Marc R Mendler MD , Jochen Essers MD , Thilo Mohns MD , Prof Andreas W Flemmer MD , Adelheid Kley MD , Hans-Jörg Bittrich MD , Bettina Bohnhorst MD , Christoph Jacobi MD , RuiMiao Bai MD , Estelle E M Mulder MD , Patrick Neuberger MD , Matthias C Hütten PhD , Ralf Rauch MD , Thomas M K Völkl MD , Thomas Höhn MD , Britta Brenner MD , Amanda Forster
<div><h3>Background</h3><div>Extremely preterm infants require respiratory support with supplemental oxygen and have frequent hypoxaemic episodes. These episodes, and exposure to inadequately high concentrations of oxygen, are associated with major complications and death. Closed-loop automated control of the fractional concentration of oxygen in inspired air (FiO<sub>2</sub>-C) reduces the time below and above the target range for the pulse oximeter oxygen saturation (SpO<sub>2</sub>) and caregivers’ workload. We aimed to study whether FiO<sub>2</sub>-C during respiratory support versus routine manual control might also improve clinical outcomes.</div></div><div><h3>Methods</h3><div>This multicentre, parallel-group, randomised, controlled, superiority trial was done in 32 neonatal intensive care units in China, Germany, the Netherlands, and the UK. Infants born at 23<sup>+0</sup> weeks to 27<sup>+6</sup> weeks postmenstrual age were included and randomly assigned to FiO<sub>2</sub>-C or routine manual care stratified within centres by postmenstrual age at birth and sex. FiO<sub>2</sub>-C was provided in addition to routine manual control of FiO<sub>2</sub> using infant ventilators. The composite primary endpoint was death, necrotising enterocolitis, or bronchopulmonary dysplasia up to 36 weeks postmenstrual age, or severe retinopathy of prematurity by 44 weeks postmenstrual age. Secondary endpoints were the components of the primary endpoint and the maximum retinopathy of prematurity severity score in either eye on the International Neonatal Consortium Retinopathy of Prematurity Activity Scale. The trial was stopped early because of poor recruitment. The primary analysis included the intention-to-treat population with non-missing primary outcome data. This trial was registered with ClinicalTrials.gov (NCT03168516) and is closed.</div></div><div><h3>Findings</h3><div>Between July 1, 2018, and Oct 31, 2023, 1082 infants were enrolled and randomly assigned to the FiO<sub>2</sub>-C group (n=539) or routine manual control group (n=543). Median postmenstrual age was 26<sup>+1</sup> weeks (IQR 24<sup>+6</sup>–27<sup>+1</sup>). 557 (51%) of 1082 infants were male and 525 (49%) were female. The primary endpoint occurred in 206 (39%) of 534 infants in the FiO<sub>2</sub>-C group versus 222 (41%) of 538 infants in the routine manual control group (adjusted odds ratio 0·90, 97·5% CI 0·65–1·24; p=0·47). Rates of death (48 [9%] of 536 infants <em>vs</em> 50 [9%] of 541 infants), necrotising enterocolitis (27 [5%] of 538 <em>vs</em> 36 [7%] of 542), bronchopulmonary dysplasia (104 [21%] of 486 <em>vs</em> 110 [23%] of 485), and severe retinopathy of prematurity (86 [18%] of 491 <em>vs</em> 95 [19%] of 496) were also similar between groups. The maximum retinopathy of prematurity severity score was similar between groups (median 7 [IQR 0–9]; p=0·24). Overall, 197 serious adverse events were reported in the FiO<sub>2</sub>-C group and 192 in the routine manual co
{"title":"Automatic versus manual control of oxygen and neonatal clinical outcomes in extremely preterm infants: a multicentre, parallel-group, randomised, controlled, superiority trial","authors":"Axel R Franz MD , Christian A Maiwald , Hendrik J Niemarkt PhD , Prof Harald Ehrhardt MD , Marc R Mendler MD , Jochen Essers MD , Thilo Mohns MD , Prof Andreas W Flemmer MD , Adelheid Kley MD , Hans-Jörg Bittrich MD , Bettina Bohnhorst MD , Christoph Jacobi MD , RuiMiao Bai MD , Estelle E M Mulder MD , Patrick Neuberger MD , Matthias C Hütten PhD , Ralf Rauch MD , Thomas M K Völkl MD , Thomas Höhn MD , Britta Brenner MD , Amanda Forster","doi":"10.1016/S2352-4642(25)00351-7","DOIUrl":"10.1016/S2352-4642(25)00351-7","url":null,"abstract":"<div><h3>Background</h3><div>Extremely preterm infants require respiratory support with supplemental oxygen and have frequent hypoxaemic episodes. These episodes, and exposure to inadequately high concentrations of oxygen, are associated with major complications and death. Closed-loop automated control of the fractional concentration of oxygen in inspired air (FiO<sub>2</sub>-C) reduces the time below and above the target range for the pulse oximeter oxygen saturation (SpO<sub>2</sub>) and caregivers’ workload. We aimed to study whether FiO<sub>2</sub>-C during respiratory support versus routine manual control might also improve clinical outcomes.</div></div><div><h3>Methods</h3><div>This multicentre, parallel-group, randomised, controlled, superiority trial was done in 32 neonatal intensive care units in China, Germany, the Netherlands, and the UK. Infants born at 23<sup>+0</sup> weeks to 27<sup>+6</sup> weeks postmenstrual age were included and randomly assigned to FiO<sub>2</sub>-C or routine manual care stratified within centres by postmenstrual age at birth and sex. FiO<sub>2</sub>-C was provided in addition to routine manual control of FiO<sub>2</sub> using infant ventilators. The composite primary endpoint was death, necrotising enterocolitis, or bronchopulmonary dysplasia up to 36 weeks postmenstrual age, or severe retinopathy of prematurity by 44 weeks postmenstrual age. Secondary endpoints were the components of the primary endpoint and the maximum retinopathy of prematurity severity score in either eye on the International Neonatal Consortium Retinopathy of Prematurity Activity Scale. The trial was stopped early because of poor recruitment. The primary analysis included the intention-to-treat population with non-missing primary outcome data. This trial was registered with ClinicalTrials.gov (NCT03168516) and is closed.</div></div><div><h3>Findings</h3><div>Between July 1, 2018, and Oct 31, 2023, 1082 infants were enrolled and randomly assigned to the FiO<sub>2</sub>-C group (n=539) or routine manual control group (n=543). Median postmenstrual age was 26<sup>+1</sup> weeks (IQR 24<sup>+6</sup>–27<sup>+1</sup>). 557 (51%) of 1082 infants were male and 525 (49%) were female. The primary endpoint occurred in 206 (39%) of 534 infants in the FiO<sub>2</sub>-C group versus 222 (41%) of 538 infants in the routine manual control group (adjusted odds ratio 0·90, 97·5% CI 0·65–1·24; p=0·47). Rates of death (48 [9%] of 536 infants <em>vs</em> 50 [9%] of 541 infants), necrotising enterocolitis (27 [5%] of 538 <em>vs</em> 36 [7%] of 542), bronchopulmonary dysplasia (104 [21%] of 486 <em>vs</em> 110 [23%] of 485), and severe retinopathy of prematurity (86 [18%] of 491 <em>vs</em> 95 [19%] of 496) were also similar between groups. The maximum retinopathy of prematurity severity score was similar between groups (median 7 [IQR 0–9]; p=0·24). Overall, 197 serious adverse events were reported in the FiO<sub>2</sub>-C group and 192 in the routine manual co","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"10 3","pages":"Pages 179-188"},"PeriodicalIF":15.5,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146147457","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 : 2026-02-10DOI: 10.1016/S2352-4642(25)00338-4
Julia Downing PhD , Prof Felicia Marie Knaul PhD , Xiaoxiao Jiang Kwete MBBS , Prof Héctor Arreola-Ornelas MSc , Nickhill Bhakta MD , William E Rosa PhD , Prof Lukas Radbruch MD , Julia Ambler MBChB Dip Pall Med , Stephen R Connor PhD , Jinfeng Ding PhD , Megan Doherty MMed , Rui Gong PhD , Prof Richard Hain MD DPhil , Rut Kiman MD , Eric L Krakauer MD PhD , Michael J McNeil MD , Oscar Méndez-Carniado BS , Marina Morais BSc , Mary Ann Muckaden MD , Tania Pastrana PD , Afsan Bhadelia PhD
<div><h3>Background</h3><div>The majority of children needing palliative care globally reside in low-income and middle-income countries (LMICs) with limited or no access to such care, resulting in an excess burden of suffering. We aimed to estimate the global burden of serious health-related suffering (SHS) among children aged 0–19 years from 1990 to 2023, providing a measurement tool essential to respond to the need for more effective palliative care policies and services for children.</div></div><div><h3>Methods</h3><div>We generated refined estimates of palliative care need for children aged 0–19 years for a 30-year time series, spanning 1990 to 2023, by extending and applying the SHS methodology originally introduced by <em>The Lancet</em> Commission on Global Access to Palliative Care and Pain Relief and subsequently updated in 2024. The updated methodology included convening an expert paediatric palliative care panel. First, the panel identified the health conditions specific to children and related parameters for estimation of the total SHS burden in children using epidemiological mortality and prevalence data within the Global Burden of Disease Study 2023 dataset. Second, to estimate the SHS burden among decedents (those who died within the past year) and non-decedents (those who survived but experienced persistent, chronic, or progressive suffering) and quantify the condition-specific palliative care need, for each health condition the panel determined the percentage of deaths or survivors who experienced SHS and thus need palliative care or the ratio of the number of survivors with SHS to the number of deaths.</div></div><div><h3>Findings</h3><div>In 2023, about 10·6 million children aged 0–19 years experienced SHS worldwide, with 96% of these children residing in LMICs. The three health conditions accounting for most of the global SHS burden in children were endocrine, metabolic, blood, and immune disorders (51% of SHS in children), premature birth and birth trauma (18%), and injury, poisoning, and external causes (7%). The annual number of children experiencing SHS changed little between 1990 and 2023, but the SHS burden shifted from primarily decedents toward non-decedents, with non-decedents accounting for 59% of the total burden of SHS in children in 1990 to 81% in 2023.</div></div><div><h3>Interpretation</h3><div>Our findings underscore the crucial need to expand access to high-quality palliative care services for children and adolescents, particularly in LMICs. Our results also highlight the shift from decedent to non-decedent care needs associated with the substantial morbidity experienced by those living with their disease. Specific health-system policies to respond to the need for increased and higher-quality paediatric palliative care, especially interventions and medicines essential to address the unique palliative care needs of children, must be adequately funded to effectively reduce the avoidable burden of SHS among child
{"title":"The global need for paediatric palliative care: the evolution of serious health-related suffering in children aged 0–19 years from 1990 to 2023","authors":"Julia Downing PhD , Prof Felicia Marie Knaul PhD , Xiaoxiao Jiang Kwete MBBS , Prof Héctor Arreola-Ornelas MSc , Nickhill Bhakta MD , William E Rosa PhD , Prof Lukas Radbruch MD , Julia Ambler MBChB Dip Pall Med , Stephen R Connor PhD , Jinfeng Ding PhD , Megan Doherty MMed , Rui Gong PhD , Prof Richard Hain MD DPhil , Rut Kiman MD , Eric L Krakauer MD PhD , Michael J McNeil MD , Oscar Méndez-Carniado BS , Marina Morais BSc , Mary Ann Muckaden MD , Tania Pastrana PD , Afsan Bhadelia PhD","doi":"10.1016/S2352-4642(25)00338-4","DOIUrl":"10.1016/S2352-4642(25)00338-4","url":null,"abstract":"<div><h3>Background</h3><div>The majority of children needing palliative care globally reside in low-income and middle-income countries (LMICs) with limited or no access to such care, resulting in an excess burden of suffering. We aimed to estimate the global burden of serious health-related suffering (SHS) among children aged 0–19 years from 1990 to 2023, providing a measurement tool essential to respond to the need for more effective palliative care policies and services for children.</div></div><div><h3>Methods</h3><div>We generated refined estimates of palliative care need for children aged 0–19 years for a 30-year time series, spanning 1990 to 2023, by extending and applying the SHS methodology originally introduced by <em>The Lancet</em> Commission on Global Access to Palliative Care and Pain Relief and subsequently updated in 2024. The updated methodology included convening an expert paediatric palliative care panel. First, the panel identified the health conditions specific to children and related parameters for estimation of the total SHS burden in children using epidemiological mortality and prevalence data within the Global Burden of Disease Study 2023 dataset. Second, to estimate the SHS burden among decedents (those who died within the past year) and non-decedents (those who survived but experienced persistent, chronic, or progressive suffering) and quantify the condition-specific palliative care need, for each health condition the panel determined the percentage of deaths or survivors who experienced SHS and thus need palliative care or the ratio of the number of survivors with SHS to the number of deaths.</div></div><div><h3>Findings</h3><div>In 2023, about 10·6 million children aged 0–19 years experienced SHS worldwide, with 96% of these children residing in LMICs. The three health conditions accounting for most of the global SHS burden in children were endocrine, metabolic, blood, and immune disorders (51% of SHS in children), premature birth and birth trauma (18%), and injury, poisoning, and external causes (7%). The annual number of children experiencing SHS changed little between 1990 and 2023, but the SHS burden shifted from primarily decedents toward non-decedents, with non-decedents accounting for 59% of the total burden of SHS in children in 1990 to 81% in 2023.</div></div><div><h3>Interpretation</h3><div>Our findings underscore the crucial need to expand access to high-quality palliative care services for children and adolescents, particularly in LMICs. Our results also highlight the shift from decedent to non-decedent care needs associated with the substantial morbidity experienced by those living with their disease. Specific health-system policies to respond to the need for increased and higher-quality paediatric palliative care, especially interventions and medicines essential to address the unique palliative care needs of children, must be adequately funded to effectively reduce the avoidable burden of SHS among child","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"10 3","pages":"Pages 167-178"},"PeriodicalIF":15.5,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146147456","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 : 2026-02-10DOI: 10.1016/S2352-4642(26)00016-7
Esther Lau , Josefine Gibson , Amy L Slogrove
{"title":"Thank you to our peer reviewers and contributors in 2025","authors":"Esther Lau , Josefine Gibson , Amy L Slogrove","doi":"10.1016/S2352-4642(26)00016-7","DOIUrl":"10.1016/S2352-4642(26)00016-7","url":null,"abstract":"","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"10 3","pages":"Page 153"},"PeriodicalIF":15.5,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146147459","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 : 2026-01-27DOI: 10.1016/S2352-4642(26)00003-9
Alan R Smyth
{"title":"Paracetamol, pyrexia, and the prevention of atopy: lessons from PIPPA Tamariki","authors":"Alan R Smyth","doi":"10.1016/S2352-4642(26)00003-9","DOIUrl":"10.1016/S2352-4642(26)00003-9","url":null,"abstract":"","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"10 3","pages":"Pages 148-149"},"PeriodicalIF":15.5,"publicationDate":"2026-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146071557","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 : 2026-01-27DOI: 10.1016/S2352-4642(25)00341-4
Eunicia Tan MBChB , Christopher J D McKinlay PhD , Judith Riley PGDipClinR , Medhawani Rao PGDipAdvNsg , Lisa Mravicich BHSc , Shirley Lawrence BHSc , Allie Eathorne MAppStat , Irene Braithwaite PhD , Alex Semprini PhD , Karaponi Okesene-Gafa PhD , Prof Nicolette Sheridan PhD , Prof Karen Hoare PhD , Prof Cameron Grant PhD , Prof David Johnson MD , Prof Mark Weatherall FRACP , Prof Richard Beasley DSc , Prof Stuart R Dalziel PhD
<div><h3>Background</h3><div>In non-experimental studies, early-life exposure to paracetamol is associated with an increased risk of eczema and wheeze. We aimed to compare paracetamol with ibuprofen, as required for fever or pain in the first year of life, for the risk of eczema and bronchiolitis at age 1 year.</div></div><div><h3>Methods</h3><div>PIPPA Tamariki is a multicentre, open-label, two-arm, parallel-group, superiority, randomised controlled trial done at three sites in Auckland and Wellington in New Zealand. Infants younger than 8 weeks and born in New Zealand were randomly assigned (1:1) to paracetamol alone (15 mg/kg every 6 h at age <1 months and every 4 h at age ≥1 months) or ibuprofen alone (5 mg/kg every 6 h at age <3 months and 10 mg/kg every 6 h at age ≥3 months), received orally as required for fever or pain, until age 1 year. Dosing was based on the <span><span>New Zealand Formulary for Children</span><svg><path></path></svg></span>. Research staff used REDCap for randomisation, which was stratified by recruitment site, maternal asthma status, and multiple birth. Key outcomes were eczema as defined by the UK Diagnostic Criteria or eczema hospitalisation in the first year of life, and hospitalisation for bronchiolitis as defined by at least one hospitalisation for bronchiolitis, viral-induced wheeze, or asthma in the first year of life. Analysis was according to the intention-to-treat principle. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618000303246 (active, not recruiting).</div></div><div><h3>Findings</h3><div>Between April 18, 2018, and July 28, 2023, 3923 infants were enrolled. 15 participants withdrew, leaving 3908 infants (1985 were randomly assigned to the paracetamol group, and 1923 to the ibuprofen group) in the intention-to-treat population. Of these participants, 1914 (49·0%) were female and 1994 (51·0%) were male; 609 (15·6%) were Māori, 607 (15·5%) were Pacific, 926 (23·7%) were Asian, and 1754 (44·9%) were New Zealand European or other. Eczema occurred in 322 (16·2%) of 1985 participants in the paracetamol group and 296 (15·4%) of 1923 participants in the ibuprofen group (absolute risk difference 0·8% [95% CI –1·5 to 3·1]; p=0·48; adjusted odds ratio [OR] 1·10 [95% CI 0·92 to 1·32]; p=0·29). Bronchiolitis occurred in 98 (4·9%) participants in the paracetamol group and 82 (4·3%) participants in the ibuprofen group (absolute risk difference 0·7% [95% CI –0·6 to 2·0]; p=0·32; adjusted OR 1·23 [95% CI 0·82 to 1·71]; p=0·21). 19 serious adverse events were reported in 17 participants (eight [0·4%] of 1985 in the paracetamol group and nine [0·5%] of 1923 in the ibuprofen group; adjusted OR 0·47 [95% CI 0·14–1·56; p=0·21]); none were attributed to trial medication.</div></div><div><h3>Interpretation</h3><div>There was no evidence of an important difference between paracetamol and ibuprofen in the risk of eczema or bronchiolitis at age 1 year.</div></div><div><h3>Fundi
在非实验研究中，早期接触扑热息痛与湿疹和喘息的风险增加有关。我们的目的是比较扑热息痛和布洛芬在1岁时发生湿疹和细支气管炎的风险，因为在1岁时需要发烧或疼痛。方法spippa Tamariki是一项多中心、开放标签、双臂、平行组、优势、随机对照试验，在新西兰奥克兰和惠灵顿的三个地点进行。在新西兰出生的小于8周的婴儿随机分配（1:1）单独服用扑热息痛（1个月大时每6小时15 mg/kg，≥1个月大时每4小时）或单独服用布洛芬（3个月大时每6小时5 mg/kg，≥3个月大时每6小时10 mg/kg），根据发烧或疼痛的需要口服，直到1岁。剂量是根据新西兰儿童处方。研究人员使用REDCap进行随机化，根据招募地点、母亲哮喘状况和多胞胎进行分层。主要结局是根据英国诊断标准定义的湿疹或出生后第一年湿疹住院治疗，以及在出生后第一年因毛细支气管炎、病毒诱发哮鸣或哮喘至少住院一次。根据意向治疗原则进行分析。该试验已在澳大利亚新西兰临床试验注册中心注册，ACTRN12618000303246（有效，未招募）。在2018年4月18日至2023年7月28日期间，共有3923名婴儿入组。15名参与者退出，在意向治疗人群中留下3908名婴儿（1985名随机分配到扑热息痛组，1923名随机分配到布洛芬组）。其中女性1914人（49.0%），男性1994人（51.0%）；609人（15.6%）为Māori， 607人（15.5%）为太平洋人，926人（23.7%）为亚洲人，1754人（44.9%）为新西兰人，欧洲人或其他。扑热息痛组1985名受试者中有322名（16.2%）发生湿疹，布洛芬组1923名受试者中有296名（15.4%）发生湿疹（绝对风险差为0.8% [95% CI -1·5 ~ 3.1];p= 0.48；校正优势比[OR] 1.10 [95% CI 0.92 ~ 1.32]; p= 0.29）。对乙酰氨基酚组有98例（4.9%）患者发生细支气管炎，布洛芬组有82例（4.3%）患者发生细支气管炎（绝对风险差为0.7% [95% CI - 0.6 ~ 2.0]; p= 0.32；调整OR为1.23 [95% CI 0.82 ~ 1.71]; p= 0.21）。17例受试者报告了19例严重不良事件（扑热息痛组1985年8例[0.4%]，布洛芬组1923年9例[0.5%]，调整后OR为0.47 [95% CI 0.14 - 1·56;p= 0.21]）；没有一例归因于试验用药。解释：没有证据表明扑热息痛和布洛芬在1岁时发生湿疹或毛细支气管炎的风险上有重要差异。资助：新西兰健康研究委员会、新西兰治愈儿童基金会、奥克兰大学。
{"title":"Paracetamol versus ibuprofen as required for fever or pain in the first year of life and the risk of eczema and bronchiolitis at age 1 year in New Zealand (PIPPA Tamariki): a multicentre, open-label, parallel-group, superiority, randomised controlled trial","authors":"Eunicia Tan MBChB , Christopher J D McKinlay PhD , Judith Riley PGDipClinR , Medhawani Rao PGDipAdvNsg , Lisa Mravicich BHSc , Shirley Lawrence BHSc , Allie Eathorne MAppStat , Irene Braithwaite PhD , Alex Semprini PhD , Karaponi Okesene-Gafa PhD , Prof Nicolette Sheridan PhD , Prof Karen Hoare PhD , Prof Cameron Grant PhD , Prof David Johnson MD , Prof Mark Weatherall FRACP , Prof Richard Beasley DSc , Prof Stuart R Dalziel PhD","doi":"10.1016/S2352-4642(25)00341-4","DOIUrl":"10.1016/S2352-4642(25)00341-4","url":null,"abstract":"<div><h3>Background</h3><div>In non-experimental studies, early-life exposure to paracetamol is associated with an increased risk of eczema and wheeze. We aimed to compare paracetamol with ibuprofen, as required for fever or pain in the first year of life, for the risk of eczema and bronchiolitis at age 1 year.</div></div><div><h3>Methods</h3><div>PIPPA Tamariki is a multicentre, open-label, two-arm, parallel-group, superiority, randomised controlled trial done at three sites in Auckland and Wellington in New Zealand. Infants younger than 8 weeks and born in New Zealand were randomly assigned (1:1) to paracetamol alone (15 mg/kg every 6 h at age <1 months and every 4 h at age ≥1 months) or ibuprofen alone (5 mg/kg every 6 h at age <3 months and 10 mg/kg every 6 h at age ≥3 months), received orally as required for fever or pain, until age 1 year. Dosing was based on the <span><span>New Zealand Formulary for Children</span><svg><path></path></svg></span>. Research staff used REDCap for randomisation, which was stratified by recruitment site, maternal asthma status, and multiple birth. Key outcomes were eczema as defined by the UK Diagnostic Criteria or eczema hospitalisation in the first year of life, and hospitalisation for bronchiolitis as defined by at least one hospitalisation for bronchiolitis, viral-induced wheeze, or asthma in the first year of life. Analysis was according to the intention-to-treat principle. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618000303246 (active, not recruiting).</div></div><div><h3>Findings</h3><div>Between April 18, 2018, and July 28, 2023, 3923 infants were enrolled. 15 participants withdrew, leaving 3908 infants (1985 were randomly assigned to the paracetamol group, and 1923 to the ibuprofen group) in the intention-to-treat population. Of these participants, 1914 (49·0%) were female and 1994 (51·0%) were male; 609 (15·6%) were Māori, 607 (15·5%) were Pacific, 926 (23·7%) were Asian, and 1754 (44·9%) were New Zealand European or other. Eczema occurred in 322 (16·2%) of 1985 participants in the paracetamol group and 296 (15·4%) of 1923 participants in the ibuprofen group (absolute risk difference 0·8% [95% CI –1·5 to 3·1]; p=0·48; adjusted odds ratio [OR] 1·10 [95% CI 0·92 to 1·32]; p=0·29). Bronchiolitis occurred in 98 (4·9%) participants in the paracetamol group and 82 (4·3%) participants in the ibuprofen group (absolute risk difference 0·7% [95% CI –0·6 to 2·0]; p=0·32; adjusted OR 1·23 [95% CI 0·82 to 1·71]; p=0·21). 19 serious adverse events were reported in 17 participants (eight [0·4%] of 1985 in the paracetamol group and nine [0·5%] of 1923 in the ibuprofen group; adjusted OR 0·47 [95% CI 0·14–1·56; p=0·21]); none were attributed to trial medication.</div></div><div><h3>Interpretation</h3><div>There was no evidence of an important difference between paracetamol and ibuprofen in the risk of eczema or bronchiolitis at age 1 year.</div></div><div><h3>Fundi","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"10 3","pages":"Pages 156-166"},"PeriodicalIF":15.5,"publicationDate":"2026-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146072281","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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