Pub Date : 2025-10-01Epub Date: 2025-09-02DOI: 10.1016/S2352-4642(25)00208-1
Khaleel Rajwani MA , Edward Jacobs DPhil , Lori Bruce DBioeth , Jamila Hokanson MD , Melanie T Almonte MSc , Faisal Feroz BA , Elisha Waldman MD , Katherine Cheung MA , Prof Neil Levy PhD , Prof Julian Savulescu PhD , Prof Ilina Singh PhD , David B Yaden PhD , Brian D Earp PhD
The potential use of psychedelic-assisted therapy for adolescents with mental illness has sparked both interest and concern. Modern psychedelic research has focused on adults, and adolescents younger than 18 years are typically excluded due to ethical and legal challenges. To explore whether adolescents have been included in 21st century psychedelic research, we conducted a scoping review of the medical literature from January, 2000, to April, 2025. Three trial registrations and one trial plan showed involvement of participants younger than 18 years, but none of these trials were completed and no trial findings have been published. The proposed studies would investigate 3,4-methylenedioxymethamphetamine (MDMA)-assisted or psilocybin-assisted psychotherapy as an intervention for adolescents with post-traumatic stress disorder, autism with social anxiety, or self-harm. Ethical approval and recruitment details were inconsistently reported. This scarcity of data highlights a major evidence gap that could hinder informed care. Given that many medications are used off-label in adolescents, we argue for cautious, ethically grounded research—starting with older adolescents with the highest foreseeable benefit–risk ratio due to special circumstances—to better understand the potential risks and benefits of psychedelic therapies for this vulnerable population.
{"title":"Clinical psychedelic research in adolescents: a scoping review and overview of ethical considerations","authors":"Khaleel Rajwani MA , Edward Jacobs DPhil , Lori Bruce DBioeth , Jamila Hokanson MD , Melanie T Almonte MSc , Faisal Feroz BA , Elisha Waldman MD , Katherine Cheung MA , Prof Neil Levy PhD , Prof Julian Savulescu PhD , Prof Ilina Singh PhD , David B Yaden PhD , Brian D Earp PhD","doi":"10.1016/S2352-4642(25)00208-1","DOIUrl":"10.1016/S2352-4642(25)00208-1","url":null,"abstract":"<div><div>The potential use of psychedelic-assisted therapy for adolescents with mental illness has sparked both interest and concern. Modern psychedelic research has focused on adults, and adolescents younger than 18 years are typically excluded due to ethical and legal challenges. To explore whether adolescents have been included in 21st century psychedelic research, we conducted a scoping review of the medical literature from January, 2000, to April, 2025. Three trial registrations and one trial plan showed involvement of participants younger than 18 years, but none of these trials were completed and no trial findings have been published. The proposed studies would investigate 3,4-methylenedioxymethamphetamine (MDMA)-assisted or psilocybin-assisted psychotherapy as an intervention for adolescents with post-traumatic stress disorder, autism with social anxiety, or self-harm. Ethical approval and recruitment details were inconsistently reported. This scarcity of data highlights a major evidence gap that could hinder informed care. Given that many medications are used off-label in adolescents, we argue for cautious, ethically grounded research—starting with older adolescents with the highest foreseeable benefit–risk ratio due to special circumstances—to better understand the potential risks and benefits of psychedelic therapies for this vulnerable population.</div></div>","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 10","pages":"Pages 744-752"},"PeriodicalIF":15.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144932491","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}
Since April 15, 2023, civil war in Sudan has created a rapidly escalating humanitarian emergency, with more than 30·4 million people requiring assistance. This Health Policy synthesises emerging evidence on the conflict's particular impact on children and women and focuses on grave violations against children in times of war, including killing and maiming, recruitment of children, sexual violence, abduction, attacks on schools and hospitals, and the denial of humanitarian access. Drawing from peer-reviewed studies, UN reports, and humanitarian field data, we highlight the scale and severity of these violations and the urgent need for a coordinated, child-centred, and gender-centred humanitarian response to ensure long-term recovery and accountability. Without an immediate end to violence, this conflict threatens the survival, development, and dignity of an entire generation in Sudan.
{"title":"Who protects the children and women of Sudan?","authors":"Georgia B Dominguez MSc , Naeha Sharma MPH , Lamia Mahmoud MD , Maysoon Dahab PhD , Prof Nafisa Bedri PhD , Prof Zulfiqar A Bhutta PhD","doi":"10.1016/S2352-4642(25)00237-8","DOIUrl":"10.1016/S2352-4642(25)00237-8","url":null,"abstract":"<div><div>Since April 15, 2023, civil war in Sudan has created a rapidly escalating humanitarian emergency, with more than 30·4 million people requiring assistance. This Health Policy synthesises emerging evidence on the conflict's particular impact on children and women and focuses on grave violations against children in times of war, including killing and maiming, recruitment of children, sexual violence, abduction, attacks on schools and hospitals, and the denial of humanitarian access. Drawing from peer-reviewed studies, UN reports, and humanitarian field data, we highlight the scale and severity of these violations and the urgent need for a coordinated, child-centred, and gender-centred humanitarian response to ensure long-term recovery and accountability. Without an immediate end to violence, this conflict threatens the survival, development, and dignity of an entire generation in Sudan.</div></div>","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 10","pages":"Pages 735-743"},"PeriodicalIF":15.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144899615","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 : 2025-10-01Epub Date: 2025-09-02DOI: 10.1016/S2352-4642(25)00193-2
Douglas A Blank PhD , Lindsay Zhou MBBS , Atul Malhotra PhD , Risha Bhatia PhD , Shiraz Badurdeen PhD , Miranda Davies-Tuck PhD , Kate Duthie MHA , Zachary Tuttle MD , Damien M Gilby MBBS , Prof Graeme R Polglase PhD , Prof Stuart B Hooper PhD , Calum T Roberts PhD
<div><h3>Background</h3><div>More than 85% of very preterm infants (born <32 weeks’ gestation) breathe spontaneously within 1 min of birth, however, more than 60% of infants receive positive pressure ventilation. Face mask application soon after birth might suppress breathing through the trigeminal nerve reflex, causing vocal cord closure and hypoxia. We aimed to investigate whether nasal mask continuous positive airway pressure (nCPAP) would improve CPAP success, reducing the need for positive pressure ventilation and intubation at birth, compared with face mask CPAP (fCPAP).</div></div><div><h3>Methods</h3><div>This open-label, randomised controlled trial was done at Monash Medical Centre (Melbourne, VIC, Australia). Eligible infants were very preterm (born at 23 weeks 0 days [23w0d]–31w6d of gestation) without known relevant congenital anomalies. Infants were randomly assigned (1:1) immediately before birth to receive initial respiratory support with nCPAP or fCPAP. Randomisation was done using a pre-generated randomisation schedule stratified by gestational age (23w0d–27w6d weeks <em>vs</em> 28w0d–31w6d gestation). Due to the nature of the intervention, investigators or clinicians were aware of treatment allocation, but the trial statistician was masked to allocations. The primary outcome was CPAP success, defined as adequate respiratory support with CPAP only, without escalation to positive pressure ventilation or intubation before neonatal unit admission. The primary outcome was assessed in the intention-to-treat population, which included all infants who were randomly assigned as per their allocated treatment. Safety was assessed in all randomly assigned infants. This study was prospectively registered with the Australian New Zealand Clinical Trials Registry, ACTRN12620001086954.</div></div><div><h3>Findings</h3><div>Between Dec 2, 2020, and March 17, 2023, we enrolled 151 infants: 74 were assigned to nCPAP and 77 to fCPAP. Mean gestation was 28 weeks and 6 days (SD 2 weeks and 6 days), mean birthweight was 1155 g (381), and 82 (54%) of 151 infants were female. 51 (34%) of 151 infants were born before 28 weeks’ gestation. More infants in the nCPAP group were successfully managed without escalation to positive pressure ventilation than infants in the fCPAP group (43 [58%] of 74 infants <em>vs</em> 30 [39%] of 77 infants; risk ratio 1·49 [95% CI 1·06–2·10]). Two infants in each group died. Pneumothorax occurred in three (4%) of 77 infants in the fCPAP group (none in the nCPAP group). Intraventricular haemorrhage occurred in 26 (34%) of 77 infants in the fCPAP group and 19 (26%) of 74 infants in the nCPAP group. Three infants had periventricular leukomalacia (one in the fCPAP group and two in the nCPAP group). Two infants in each group underwent surgery for necrotising enterocolitis and one (1%) of 77 infants in the fCPAP group had surgery for intestinal perforation (none in the nCPAP group). 13 (17%) of 77 infants in the fCPAP group and 1
{"title":"Face mask versus nasal mask device use for initial resuscitation in extremely and very preterm infants (FONDUE): an open-label, single-centre, randomised, controlled trial","authors":"Douglas A Blank PhD , Lindsay Zhou MBBS , Atul Malhotra PhD , Risha Bhatia PhD , Shiraz Badurdeen PhD , Miranda Davies-Tuck PhD , Kate Duthie MHA , Zachary Tuttle MD , Damien M Gilby MBBS , Prof Graeme R Polglase PhD , Prof Stuart B Hooper PhD , Calum T Roberts PhD","doi":"10.1016/S2352-4642(25)00193-2","DOIUrl":"10.1016/S2352-4642(25)00193-2","url":null,"abstract":"<div><h3>Background</h3><div>More than 85% of very preterm infants (born <32 weeks’ gestation) breathe spontaneously within 1 min of birth, however, more than 60% of infants receive positive pressure ventilation. Face mask application soon after birth might suppress breathing through the trigeminal nerve reflex, causing vocal cord closure and hypoxia. We aimed to investigate whether nasal mask continuous positive airway pressure (nCPAP) would improve CPAP success, reducing the need for positive pressure ventilation and intubation at birth, compared with face mask CPAP (fCPAP).</div></div><div><h3>Methods</h3><div>This open-label, randomised controlled trial was done at Monash Medical Centre (Melbourne, VIC, Australia). Eligible infants were very preterm (born at 23 weeks 0 days [23w0d]–31w6d of gestation) without known relevant congenital anomalies. Infants were randomly assigned (1:1) immediately before birth to receive initial respiratory support with nCPAP or fCPAP. Randomisation was done using a pre-generated randomisation schedule stratified by gestational age (23w0d–27w6d weeks <em>vs</em> 28w0d–31w6d gestation). Due to the nature of the intervention, investigators or clinicians were aware of treatment allocation, but the trial statistician was masked to allocations. The primary outcome was CPAP success, defined as adequate respiratory support with CPAP only, without escalation to positive pressure ventilation or intubation before neonatal unit admission. The primary outcome was assessed in the intention-to-treat population, which included all infants who were randomly assigned as per their allocated treatment. Safety was assessed in all randomly assigned infants. This study was prospectively registered with the Australian New Zealand Clinical Trials Registry, ACTRN12620001086954.</div></div><div><h3>Findings</h3><div>Between Dec 2, 2020, and March 17, 2023, we enrolled 151 infants: 74 were assigned to nCPAP and 77 to fCPAP. Mean gestation was 28 weeks and 6 days (SD 2 weeks and 6 days), mean birthweight was 1155 g (381), and 82 (54%) of 151 infants were female. 51 (34%) of 151 infants were born before 28 weeks’ gestation. More infants in the nCPAP group were successfully managed without escalation to positive pressure ventilation than infants in the fCPAP group (43 [58%] of 74 infants <em>vs</em> 30 [39%] of 77 infants; risk ratio 1·49 [95% CI 1·06–2·10]). Two infants in each group died. Pneumothorax occurred in three (4%) of 77 infants in the fCPAP group (none in the nCPAP group). Intraventricular haemorrhage occurred in 26 (34%) of 77 infants in the fCPAP group and 19 (26%) of 74 infants in the nCPAP group. Three infants had periventricular leukomalacia (one in the fCPAP group and two in the nCPAP group). Two infants in each group underwent surgery for necrotising enterocolitis and one (1%) of 77 infants in the fCPAP group had surgery for intestinal perforation (none in the nCPAP group). 13 (17%) of 77 infants in the fCPAP group and 1","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 10","pages":"Pages 715-723"},"PeriodicalIF":15.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144932492","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}
Adolescence is a pivotal stage for sexual and reproductive health and rights (SRHR). Young adolescents (aged 10–14 years) undergo sexual and reproductive maturation, yet research on their SRHR lags behind that of older adolescents. To address this gap, WHO commissioned a research priority-setting exercise focused on the SRHR of young adolescents using an adapted mixed-methods Child Health and Nutrition Research Initiative methodology. Over 300 stakeholders from more than 60 countries—including academics, policy makers, advocates, and youth advisors—participated in defining and evaluating research priorities against two evaluation criteria: answerability and impact. 30 research priorities were identified, with top-ranked priorities focusing on the role of social media in young adolescents' SRHR, mental health challenges, and disparities in SRHR needs among marginalised subpopulations. The findings highlight the importance of ethical engagement with young adolescents and implementation of tailored comprehensive sexuality education. The identified research priorities emphasise the need for scalable interventions and policies that align with young adolescents' developmental needs and the needs of their caregivers while addressing sociocultural barriers. The research priorities also reflect a clear ambition to develop and implement co-designed, age-appropriate, and scalable SRHR education and health interventions for young adolescents, laying the foundation for long-term wellbeing.
{"title":"Global research priority-setting exercise on the sexual and reproductive health and rights of young adolescents","authors":"Maria Lohan PhD , Aoibheann Brennan-Wilson PhD , Melissa Bradshaw MA , Sheri Bastien PhD , Prerna Banati PhD , John Garry PhD , Alejandra LÓpez GÓmez PhD , Caroline Moreau MD PhD , Chunyan Yu PhD , Kristin Mmari DrPH , Md Mizanur Rahman PhD , Caroline W Kabiru PhD , Mark Tomlinson PhD","doi":"10.1016/S2352-4642(25)00190-7","DOIUrl":"10.1016/S2352-4642(25)00190-7","url":null,"abstract":"<div><div>Adolescence is a pivotal stage for sexual and reproductive health and rights (SRHR). Young adolescents (aged 10–14 years) undergo sexual and reproductive maturation, yet research on their SRHR lags behind that of older adolescents. To address this gap, WHO commissioned a research priority-setting exercise focused on the SRHR of young adolescents using an adapted mixed-methods Child Health and Nutrition Research Initiative methodology. Over 300 stakeholders from more than 60 countries—including academics, policy makers, advocates, and youth advisors—participated in defining and evaluating research priorities against two evaluation criteria: answerability and impact. 30 research priorities were identified, with top-ranked priorities focusing on the role of social media in young adolescents' SRHR, mental health challenges, and disparities in SRHR needs among marginalised subpopulations. The findings highlight the importance of ethical engagement with young adolescents and implementation of tailored comprehensive sexuality education. The identified research priorities emphasise the need for scalable interventions and policies that align with young adolescents' developmental needs and the needs of their caregivers while addressing sociocultural barriers. The research priorities also reflect a clear ambition to develop and implement co-designed, age-appropriate, and scalable SRHR education and health interventions for young adolescents, laying the foundation for long-term wellbeing.</div></div>","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 10","pages":"Pages 724-734"},"PeriodicalIF":15.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144857734","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 : 2025-10-01Epub Date: 2025-09-02DOI: 10.1016/S2352-4642(25)00239-1
Javier Arredondo Montero
{"title":"Against the cult of complexity: generalism as a radical act","authors":"Javier Arredondo Montero","doi":"10.1016/S2352-4642(25)00239-1","DOIUrl":"10.1016/S2352-4642(25)00239-1","url":null,"abstract":"","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 10","pages":"Page 697"},"PeriodicalIF":15.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144932495","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 : 2025-10-01Epub Date: 2025-08-07DOI: 10.1016/S2352-4642(25)00187-7
Neil Gupta , Ana Olga Machatine De Almeida Hausse Mocumbi , Fouzia Shafique , Raoul Bermejo , Gene Bukhman
{"title":"Child and adolescent mortality from severe NCDs and injuries: a call for inclusion","authors":"Neil Gupta , Ana Olga Machatine De Almeida Hausse Mocumbi , Fouzia Shafique , Raoul Bermejo , Gene Bukhman","doi":"10.1016/S2352-4642(25)00187-7","DOIUrl":"10.1016/S2352-4642(25)00187-7","url":null,"abstract":"","PeriodicalId":54238,"journal":{"name":"Lancet Child & Adolescent Health","volume":"9 10","pages":"Pages 689-691"},"PeriodicalIF":15.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144812967","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 : 2025-10-01Epub Date: 2025-08-12DOI: 10.1016/S2352-4642(25)00185-3
Louise S Owen MD , Elizabeth E Foglia MD MSCE , Prof Sarah J Ratcliffe PhD , Prof Burkhard Simma MD , Anup C Katheria MD , Prof Arjan te Pas MD PhD , Wes Onland MD PhD , Prof Anton H van Kaam MD PhD , Prof Martin Keszler MD , Prof Haresh Kirpalani BM MSc , Prof Peter G Davis MD
<div><h3>Background</h3><div>Delivery room trials face ethical and logistical enrolment challenges, including requirements for prospective, antenatal, parental consent. The Sustained Aeration of Infant Lungs (SAIL) study was a randomised controlled trial of two resuscitation strategies at birth, enrolling infants using both prospective antenatal consent and deferred postnatal (consent-to-continue) pathways. We aimed to compare recruitment and outcomes between SAIL trial centres with deferred consent available versus centres only using prospective antenatal consent.</div></div><div><h3>Method</h3><div>This study is a secondary analysis of the data from the open-label, international, multicentre, randomised SAIL trial. Infants born at 23 to less than 27 weeks' gestation at 18 centres across nine countries who were deemed to require intermittent positive pressure ventilation due to inadequate respiratory efforts or bradycardia, had no known major congenital anomalies, and were neither stillborn nor considered to be non-viable by their clinician were eligible for inclusion. Centres were compared by consent mode availability: antenatal consent only versus centres with deferred consent available. The primary outcome was the combined rate of death or bronchopulmonary dysplasia compared between consent type groups. People with lived experience did not contribute to the design or implementation of the SAIL trial. The SAIL trial was registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT02139800</span><svg><path></path></svg></span>).</div></div><div><h3>Findings</h3><div>The SAIL trial recruited 426 infants (222 [52%] were male and 204 [48%] were female) born from 371 mothers (218 [59%] were White) between Aug 27, 2014, and Sept 14, 2017. In 12 centres using only antenatal consent, 197 (41%) of 479 eligible infants were recruited and included in analysis compared with 229 (73%) of 313 eligible infants from six centres where deferred consent was available (with or without antenatal consent; absolute difference 31·78% [95% CI 24·46–39·10; p<0·0001]). Deferred consent was not obtained from 34 (15%) of 225 infants randomly assigned via the deferred pathway, who were excluded from this analysis. Compared with centres using only antenatal consent, infants recruited at deferred consent centres had less exposure to antenatal corticosteroids (166 [84%] of 197 <em>vs</em> 167 [73%] of 229 infants, p=0·012); were more likely to be male (88 [45%] <em>vs</em> 134 [59%], p=0·0065); were heavier (median birthweight 687 g [IQR 558–817] <em>vs</em> 767 g [661–870], p<0·0001); were less likely to be growth restricted (34 [27%] <em>vs</em> 19 [8%], p=0·0075); and less frequently intubated at birth (125 [63%] <em>vs</em> 105 [46%], p=0·0005). The rate of death or bronchopulmonary dysplasia at deferred consent centres was 65% (149/229) versus 57% (113/197) at antenatal consent centres (adjusted relative risk 1·18 [95% CI 0·9
产房试验面临着伦理和后勤方面的挑战，包括对预期、产前和父母同意的要求。婴儿肺持续通气（SAIL）研究是一项随机对照试验，在出生时采用两种复苏策略，采用前瞻性产前同意和延期产后（同意-继续）途径招募婴儿。我们的目的是比较具有延迟同意的SAIL试验中心与仅使用前瞻性产前同意的SAIL试验中心的招募和结果。方法：本研究是对开放标签、国际、多中心、随机SAIL试验数据的二次分析。在9个国家的18个中心出生的妊娠23至27周以下的婴儿，由于呼吸努力不足或心动过缓被认为需要间歇性正压通气，没有已知的重大先天性异常，既不是死产，也不是临床医生认为无法生存，符合纳入条件。中心通过同意模式的可用性进行比较：仅产前同意与延迟同意的中心。主要结局是同意型组之间的死亡率或支气管肺发育不良的综合比率的比较。有生活经验的人没有参与SAIL试验的设计或实施。SAIL试验已在ClinicalTrials.gov注册（NCT02139800）。在2014年8月27日至2017年9月14日期间，SAIL试验招募了371名母亲（218名[59%]为白人）所生的426名婴儿（222名[52%]为男性，204名[48%]为女性）。在12个只使用产前同意的中心，479名合格婴儿中有197名（41%）被招募并纳入分析，而在6个提供延期同意的中心(有或没有产前同意；绝对差异31.78% [95% CI 24.46 ~ 39.10；p < 0·0001)。通过延迟途径随机分配的225名婴儿中有34名（15%）未获得延迟同意，他们被排除在本分析之外。与仅使用产前同意的中心相比，在延迟同意中心招募的婴儿较少接触产前皮质类固醇（197名婴儿中的166名[84%]vs 229名婴儿中的167名[73%]，p= 0.012）；男性居多（88人[45%]vs 134人[59%]，p= 0.0065）；体重较重（中位出生体重687 g [IQR 558-817] vs 767 g [IQR 661-870]， p< 0.0001）；生长受限的可能性较低（34例[27%]vs 19例[8%]，p= 0.0075）；出生时插管次数较少（125例[63%]vs 105例[46%]，p= 0.0005）。延迟同意中心的死亡率或支气管肺发育不良率为65%(149/229)，而产前同意中心的死亡率为57%(113/197)（调整后相对风险为1.18 [95% CI 0.98 - 1.42]）。解释：与仅使用产前同意的中心相比，提供延期同意的中心招募了更高比例的符合条件的高风险婴儿，他们的发病率更高，反映了更广泛、更普遍的人口样本。美国国家儿童健康和人类发展研究所。
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