Pub Date : 2025-11-10DOI: 10.1136/archdischild-2025-329022
Ourania Kaltsogianni, Theodore Dassios, Allan Jenkinson, Eleanor Jeffreys, Kenta Ikeda, Masashiro Sugino, Anne Greenough
Objective: To compare the duration of mechanical ventilation between preterm infants receiving closed-loop automated oxygen control (CLAC) or manual oxygen control.
Design: Randomised controlled trial.
Setting: Tertiary neonatal unit in London, UK.
Patients: Infants (n=69) with a median (IQR) gestational age of 27.0 (25.6-29.0) weeks studied at a corrected postmenstrual age of 27.6 (25.9-29.1) weeks.
Interventions: Infants were randomised to CLAC or manual oxygen control within 48 hours of initiation of mechanical ventilation if less than 7 days of age until successful extubation.
Main outcome measures: Duration of mechanical ventilation.
Results: The CLAC infants (n=34) compared with those who received manual control had a shorter duration of mechanical ventilation (median (range): 11 (1-57) vs 40 (3-134) days, p=0.027), a shorter duration of supplemental oxygen (median (range): 33 (0-100) vs 47 (3-335) days, p=0.031), a lower incidence of bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age (55% vs 83.9%, p=0.015) and fewer required home oxygen (26.5% vs 51.4%, p=0.016). In the CLAC infants, the time spent in the target oxygen range (91%-95%) was increased (p<0.001) and the times spent in hypoxaemia (peripheral oxygen saturation level (SpO2)<85%) and hyperoxaemia (SpO2>95%) were reduced (p<0.001).
Conclusions: Use of CLAC in preterm, ventilated infants was associated with improved achievement of oxygen saturation targets, shorter durations of mechanical ventilation and supplemental oxygen treatment and a lower incidence of BPD. These results need to be replicated in larger multicentre studies before any change in routine practice could be recommended.
Trial registration number: NCT05030337.
目的:比较采用闭环自动氧控(CLAC)和人工氧控的早产儿机械通气时间。设计:随机对照试验。环境:第三新生儿单位在英国伦敦。患者:研究中位(IQR)胎龄为27.0(25.6-29.0)周的婴儿(n=69),校正后经后年龄为27.6(25.9-29.1)周。干预措施:如果婴儿小于7天,则在开始机械通气48小时内随机分配CLAC或手动氧气控制,直到拔管成功。主要观察指标:机械通气时间。结果:CLAC婴儿(n=34)与接受手动控制的婴儿相比,机械通气持续时间较短(中位数(范围):11 (1-57)vs 40(3-134)天,p=0.027),补充氧气持续时间较短(中位数(范围):33 (0-100)vs 47(3-335)天,p=0.031),经后36周支气管肺发育不良(BPD)发生率较低(55% vs 83.9%, p=0.015),所需家庭氧气较少(26.5% vs 51.4%, p=0.016)。在CLAC婴儿中,在目标氧气范围(91%-95%)内花费的时间增加(p2)2>95%)减少(p结论:早产儿,通气婴儿使用CLAC与提高氧饱和度目标的实现,缩短机械通气和补充氧治疗的持续时间以及降低BPD发生率相关。这些结果需要在更大的多中心研究中得到重复,然后才能推荐改变常规做法。试验注册号:NCT05030337。
{"title":"Closed-loop automated oxygen control in preterm ventilated infants: a randomised controlled trial.","authors":"Ourania Kaltsogianni, Theodore Dassios, Allan Jenkinson, Eleanor Jeffreys, Kenta Ikeda, Masashiro Sugino, Anne Greenough","doi":"10.1136/archdischild-2025-329022","DOIUrl":"https://doi.org/10.1136/archdischild-2025-329022","url":null,"abstract":"<p><strong>Objective: </strong>To compare the duration of mechanical ventilation between preterm infants receiving closed-loop automated oxygen control (CLAC) or manual oxygen control.</p><p><strong>Design: </strong>Randomised controlled trial.</p><p><strong>Setting: </strong>Tertiary neonatal unit in London, UK.</p><p><strong>Patients: </strong>Infants (n=69) with a median (IQR) gestational age of 27.0 (25.6-29.0) weeks studied at a corrected postmenstrual age of 27.6 (25.9-29.1) weeks.</p><p><strong>Interventions: </strong>Infants were randomised to CLAC or manual oxygen control within 48 hours of initiation of mechanical ventilation if less than 7 days of age until successful extubation.</p><p><strong>Main outcome measures: </strong>Duration of mechanical ventilation.</p><p><strong>Results: </strong>The CLAC infants (n=34) compared with those who received manual control had a shorter duration of mechanical ventilation (median (range): 11 (1-57) vs 40 (3-134) days, p=0.027), a shorter duration of supplemental oxygen (median (range): 33 (0-100) vs 47 (3-335) days, p=0.031), a lower incidence of bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age (55% vs 83.9%, p=0.015) and fewer required home oxygen (26.5% vs 51.4%, p=0.016). In the CLAC infants, the time spent in the target oxygen range (91%-95%) was increased (p<0.001) and the times spent in hypoxaemia (peripheral oxygen saturation level (SpO<sub>2</sub>)<85%) and hyperoxaemia (SpO<sub>2</sub>>95%) were reduced (p<0.001).</p><p><strong>Conclusions: </strong>Use of CLAC in preterm, ventilated infants was associated with improved achievement of oxygen saturation targets, shorter durations of mechanical ventilation and supplemental oxygen treatment and a lower incidence of BPD. These results need to be replicated in larger multicentre studies before any change in routine practice could be recommended.</p><p><strong>Trial registration number: </strong>NCT05030337.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145494400","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-10DOI: 10.1136/archdischild-2025-329844
George Clough, Christopher Harris, Anne Greenough, Anthony Richard Hart
{"title":"Trials of medications for neonatal seizures: time for pragmatism.","authors":"George Clough, Christopher Harris, Anne Greenough, Anthony Richard Hart","doi":"10.1136/archdischild-2025-329844","DOIUrl":"https://doi.org/10.1136/archdischild-2025-329844","url":null,"abstract":"","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145493862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-24DOI: 10.1136/archdischild-2024-328079
Yuanjun Wu, Ganping Guo, Yinglin Wu, Liangchang Xiu, Yanli Ji, Minxu Li, Manna Sun, Xinghe Wang, Xuejun Ren, Lan Zhang, Jianqun Li, Shujie Wu, Miaozhen Wen, Jiajun Zeng, Qianquan Yuan, Zhongying Xie, Yong Yang
Background: It has traditionally been considered that mother-infant ABO incompatibility only causes mild haemolytic disease of the newborn (HDN). However, this view is inconsistent with clinical practice, and large-scale population-based data are lacking to investigate its effects on neonates.
Methods: Differences in hospitalisation rates and incidence rates of neonatal hyperbilirubinaemia (NHB) and anaemia among 47 679 Chinese liveborn neonates with different mother-infant ABO combinations, differences in the incidence of ABO-incompatible HDN (ABO-HDN) among neonates with O-B versus O-A mother-infant ABO incompatibility, and the contributions of ABO-HDN to the development of NHB and neonatal anaemia were analysed.
Results: Of the 47 679 liveborn neonates, neonates with mother-infant ABO incompatibility had higher rates of hospitalisation and incidence of NHB and anaemia. The hierarchy of the risk of mother-infant ABO incompatibility to the neonate was O-B > O-A > non-O-A/O-B incompatibility. Among neonates with O-B and O-A mother-infant ABO incompatibility, the ABO-HDN incidence rates were 15.27% (513/3359) and 11.33% (417/3680), respectively (95% CI 1.41 (1.23 to 1.62)), and the severe ABO-HDN incidence rates were 2.05% (69/3359) and 1.14% (42/3680), respectively (95% CI 1.82 (1.23 to 2.67)). Among the 7039 neonates with O-A/O-B mother-infant ABO incompatibility, ABO-HDN was an independent aetiological factor in 41.11% (666/1620) of the neonates with NHB, 70.27% (52/74) of the neonates with severe NHB, 42.34% (163/385) of the neonates with anaemia and 18.28% (17/93) of the neonates with severe anaemia.
Conclusions: Mother-infant ABO incompatibility often leads to severe HDN and is a dominant cause of NHB and neonatal anaemia, leading to significantly higher neonatal hospitalisation rates.
背景:传统上认为母婴ABO不合只会引起新生儿轻度溶血病(HDN)。然而,这种观点与临床实践不一致,并且缺乏大规模的基于人群的数据来调查其对新生儿的影响。方法:分析47679例不同ABO血型组合的中国活产新生儿高胆红素血症(NHB)和贫血的住院率和发病率的差异,O-B型与O-A型ABO血型不相容新生儿ABO-不相容HDN (ABO-HDN)发生率的差异,以及ABO-HDN对新生儿高胆红素血症和贫血的影响。结果:在47679例活产新生儿中,母婴ABO不相容的新生儿住院率、NHB和贫血发生率较高。母婴ABO血型不合对新生儿的风险分级为O-B b> O-A >非O-A/O-B不合。O-B型和O-A型母婴ABO不相容患儿ABO- hdn发生率分别为15.27%(513/3359)和11.33% (417/3680)(95% CI 1.41(1.23 ~ 1.62)),重度ABO- hdn发生率分别为2.05%(69/3359)和1.14% (42/3680)(95% CI 1.82(1.23 ~ 2.67))。在7039例O-A/O-B母婴ABO配型不匹配的新生儿中,ABO- hdn是独立病因,占41.11%(666/1620)的NHB、70.27%(52/74)的重度NHB、42.34%(163/385)的贫血和18.28%(17/93)的重度贫血。结论:母婴ABO不合常导致严重HDN,是NHB和新生儿贫血的主要原因,导致新生儿住院率显著升高。
{"title":"Effects of mother-infant ABO incompatibility on neonates: a cohort study in the Chinese population.","authors":"Yuanjun Wu, Ganping Guo, Yinglin Wu, Liangchang Xiu, Yanli Ji, Minxu Li, Manna Sun, Xinghe Wang, Xuejun Ren, Lan Zhang, Jianqun Li, Shujie Wu, Miaozhen Wen, Jiajun Zeng, Qianquan Yuan, Zhongying Xie, Yong Yang","doi":"10.1136/archdischild-2024-328079","DOIUrl":"10.1136/archdischild-2024-328079","url":null,"abstract":"<p><strong>Background: </strong>It has traditionally been considered that mother-infant ABO incompatibility only causes mild haemolytic disease of the newborn (HDN). However, this view is inconsistent with clinical practice, and large-scale population-based data are lacking to investigate its effects on neonates.</p><p><strong>Methods: </strong>Differences in hospitalisation rates and incidence rates of neonatal hyperbilirubinaemia (NHB) and anaemia among 47 679 Chinese liveborn neonates with different mother-infant ABO combinations, differences in the incidence of ABO-incompatible HDN (ABO-HDN) among neonates with O-B versus O-A mother-infant ABO incompatibility, and the contributions of ABO-HDN to the development of NHB and neonatal anaemia were analysed.</p><p><strong>Results: </strong>Of the 47 679 liveborn neonates, neonates with mother-infant ABO incompatibility had higher rates of hospitalisation and incidence of NHB and anaemia. The hierarchy of the risk of mother-infant ABO incompatibility to the neonate was O-B > O-A > non-O-A/O-B incompatibility. Among neonates with O-B and O-A mother-infant ABO incompatibility, the ABO-HDN incidence rates were 15.27% (513/3359) and 11.33% (417/3680), respectively (95% CI 1.41 (1.23 to 1.62)), and the severe ABO-HDN incidence rates were 2.05% (69/3359) and 1.14% (42/3680), respectively (95% CI 1.82 (1.23 to 2.67)). Among the 7039 neonates with O-A/O-B mother-infant ABO incompatibility, ABO-HDN was an independent aetiological factor in 41.11% (666/1620) of the neonates with NHB, 70.27% (52/74) of the neonates with severe NHB, 42.34% (163/385) of the neonates with anaemia and 18.28% (17/93) of the neonates with severe anaemia.</p><p><strong>Conclusions: </strong>Mother-infant ABO incompatibility often leads to severe HDN and is a dominant cause of NHB and neonatal anaemia, leading to significantly higher neonatal hospitalisation rates.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145298133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-21DOI: 10.1136/archdischild-2025-329567
Cornelia Wiechers
{"title":"Suboptimal BMI at 5 years after very preterm birth: too early to conclude?","authors":"Cornelia Wiechers","doi":"10.1136/archdischild-2025-329567","DOIUrl":"10.1136/archdischild-2025-329567","url":null,"abstract":"","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145257228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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: 10.1136/archdischild-2025-328480
George S Bethell, Nigel J Hall, Cheryl Battersby, Marian Knight, Anne-Sophie Darlington
Objective: To understand why surgical decision-making in necrotising enterocolitis (NEC) is challenging and to explore what is required to optimise this.
Design: Three semi-structured in-person focus groups exploring surgical decision-making in NEC. Reflexive thematic analysis of the focus group transcript was undertaken.
Participants: 22 consultant participants (15 paediatric surgeons and 7 neonatologists).
Main outcome measures: Themes addressing what informs, the challenges of and how to improve surgical decision-making in NEC.
Results: 10 themes addressed what informs decision-making in NEC, 6 themes addressed why this is challenging and 5 themes explained what is required to address the challenges of decision-making. Themes regarding challenges of decision-making were: diagnostic uncertainty, variable threshold for referral/transfer, lack of continuity of care, absence of clear criteria for surgery, uncertainty surrounding surgery and fear. Subthemes regarding fear were fear of (1) poor clinical outcome, (2) criticism from colleagues and (3) undertaking unnecessary surgery.Themes in all three areas were related to infant, clinician and system-based factors. These included themes regarding indications for surgical intervention, indications for referral and transfer of infants, and reducing variability in practice.
Conclusions: This study identified themes that illuminate the difficulties experienced by neonatologists and surgeons regarding surgical decision-making in NEC. Clinicians of both specialties would welcome changes to current practice focused particularly around standardisation of practice and greater objectivity around several aspects of surgical decision-making. These insights can be used to focus further research and implement practice change around surgical decision-making in NEC with the ultimate aim of facilitating early and accurate decision-making.
{"title":"Surgeons and neonatologists views about surgical decision-making in necrotising enterocolitis.","authors":"George S Bethell, Nigel J Hall, Cheryl Battersby, Marian Knight, Anne-Sophie Darlington","doi":"10.1136/archdischild-2025-328480","DOIUrl":"10.1136/archdischild-2025-328480","url":null,"abstract":"<p><strong>Objective: </strong>To understand why surgical decision-making in necrotising enterocolitis (NEC) is challenging and to explore what is required to optimise this.</p><p><strong>Design: </strong>Three semi-structured in-person focus groups exploring surgical decision-making in NEC. Reflexive thematic analysis of the focus group transcript was undertaken.</p><p><strong>Participants: </strong>22 consultant participants (15 paediatric surgeons and 7 neonatologists).</p><p><strong>Main outcome measures: </strong>Themes addressing what informs, the challenges of and how to improve surgical decision-making in NEC.</p><p><strong>Results: </strong>10 themes addressed what informs decision-making in NEC, 6 themes addressed why this is challenging and 5 themes explained what is required to address the challenges of decision-making. Themes regarding challenges of decision-making were: diagnostic uncertainty, variable threshold for referral/transfer, lack of continuity of care, absence of clear criteria for surgery, uncertainty surrounding surgery and fear. Subthemes regarding fear were fear of (1) poor clinical outcome, (2) criticism from colleagues and (3) undertaking unnecessary surgery.Themes in all three areas were related to infant, clinician and system-based factors. These included themes regarding indications for surgical intervention, indications for referral and transfer of infants, and reducing variability in practice.</p><p><strong>Conclusions: </strong>This study identified themes that illuminate the difficulties experienced by neonatologists and surgeons regarding surgical decision-making in NEC. Clinicians of both specialties would welcome changes to current practice focused particularly around standardisation of practice and greater objectivity around several aspects of surgical decision-making. These insights can be used to focus further research and implement practice change around surgical decision-making in NEC with the ultimate aim of facilitating early and accurate decision-making.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"595-601"},"PeriodicalIF":3.6,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12573361/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-17DOI: 10.1136/archdischild-2025-328784
Chad Andersen, Danielle Nicole Bailey, Tara Marie Crawford, Michael Stark
{"title":"Haemoglobin-oxygen affinity and the risk of bronchopulmonary dysplasia.","authors":"Chad Andersen, Danielle Nicole Bailey, Tara Marie Crawford, Michael Stark","doi":"10.1136/archdischild-2025-328784","DOIUrl":"10.1136/archdischild-2025-328784","url":null,"abstract":"","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"629-630"},"PeriodicalIF":3.6,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144131839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: Definitive guidance regarding the duration of antibiotics for neonatal sepsis is lacking. We hypothesised that a 7-day antibiotic course is non-inferior to a 14-day course for treating culture-proven sepsis.
Design: Randomised, controlled, non-inferiority trial with masked outcome assessment in eight centres in a low and middle-income country.
Patients: Neonates with a birth weight (BW) ≥1000 g and blood culture-proven sepsis were randomised on day 7 of sensitive antibiotic therapy provided sepsis had clinically remitted.
Exclusions: Staphylococcus aureus or fungal sepsis, and infections requiring prolonged antibiotics. We planned to enrol 350 per group, assuming 10% rate of primary outcome, +7% non-inferiority margin, one-sided 5% alpha, 90% power, 10% loss to follow-up.
Intervention: 7 days (no further treatment); comparison: 14 days (7 days postrandomisation).
Outcomes: Primary: relapse (definite or probable) within day 21 postantibiotic completion.
Secondary outcomes: composite of mortality or definite/probable/secondary sepsis and duration of hospitalisation. One interim analysis (per protocol (PP)) was planned.
Results: 126 and 135 subjects were recruited in 7-day and 14-day groups, respectively, with mean (SD) birth weight (BW) 2250.9 (741.1) and 2187.8 (718.8) g. The trial was terminated early, based on interim PP analysis. 2/125 and 6/130 subjects had the primary outcome in 7-day and 14-day groups, respectively (risk difference (RD)=-3.0% (99.5% CI -9.2%, +3.1%), below non-inferiority margin). The composite secondary outcome also favoured the 7-day regimen (RD: -3.7% (99.5% CI -12.4% to +5.1%)). Duration of hospitalisation was shorter in 7-day group (median difference: -4 days (95% CI -5 to -3)).
Conclusions: A 7-day course of antibiotics may be non-inferior to a 14-day course for uncomplicated bacterial neonatal sepsis.
Trial registration number: NCT03280147.
目的:缺乏关于新生儿败血症抗生素持续时间的明确指导。我们假设在治疗培养证实的败血症方面,7天的抗生素疗程不逊色于14天的疗程。设计:随机、对照、非劣效性试验,在一个低收入和中等收入国家的8个中心进行掩盖结果评估。患者:出生体重(BW)≥1000 g且血培养证实败血症的新生儿在敏感抗生素治疗的第7天随机分组,前提是败血症临床缓解。排除:金黄色葡萄球菌或真菌败血症,以及需要长期使用抗生素的感染。我们计划每组入组350人,假设主要转归率为10%,非劣效性裕度为+7%,alpha值为5%,功效为90%,随访损失为10%。干预:7天(无进一步治疗);比较:14天(随机化后7天)。结果:原发性:在抗生素完成后21天内复发(明确或可能)。次要结局:死亡率或明确/可能/继发性败血症和住院时间的综合结果。计划一次中期分析(每个方案(PP))。结果:7天组126例,14天组135例,平均(SD)出生体重(BW) 2250.9 (741.1), 2187.8 (718.8) g。根据中期PP分析,试验提前终止。2/125和6/130受试者分别在7天和14天组中有主要结局(风险差异(RD)=-3.0% (99.5% CI -9.2%, +3.1%),低于非劣效边际)。综合次要结局也有利于7天方案(RD: -3.7% (99.5% CI -12.4%至+5.1%))。7天组住院时间较短(中位差:-4天(95% CI -5至-3))。结论:对于无并发症的新生儿细菌性脓毒症,7天疗程的抗生素治疗可能不逊色于14天疗程。试验注册号:NCT03280147。
{"title":"Seven-day versus 14-day antibiotic course for culture-proven neonatal sepsis: a multicentre randomised non-inferiority trial in a low and middle-income country.","authors":"Sourabh Dutta, Sushma Nangia, Mamta Jajoo, MangalaBharathi Sundaram, Mala Kumar, Niranjan Shivanna, Geeta Gathwala, Saudamini Nesargi, Suksham Jain, Praveen Kumar, Arvind Saili, Arun Karthik, Shalini Tripathi, Prathik Bandiya, Poonam Dalal, Pallab Ray, Valinderjeet Singh Randhawa, Karnika Saigal, Devasena Radhakrishnan, Vimla Venkatesh, Bhavana Jagannatha, Madhu Sharma, Savitha Nagaraj, Meenakshi Malik, Sarita Dogra, Suruchi Mittal, Anumeet Saini, Nisha Makkar, Maitreyi Dhir, Asmita Chandramohan, R A Pragati, Tanaya Srivastava, Lakshmi Mukundan, Naveen Benakappa, Amlin Shukla, Reeta Rasaily","doi":"10.1136/archdischild-2024-328232","DOIUrl":"10.1136/archdischild-2024-328232","url":null,"abstract":"<p><strong>Objective: </strong>Definitive guidance regarding the duration of antibiotics for neonatal sepsis is lacking. We hypothesised that a 7-day antibiotic course is non-inferior to a 14-day course for treating culture-proven sepsis.</p><p><strong>Design: </strong>Randomised, controlled, non-inferiority trial with masked outcome assessment in eight centres in a low and middle-income country.</p><p><strong>Patients: </strong>Neonates with a birth weight (BW) ≥1000 g and blood culture-proven sepsis were randomised on day 7 of sensitive antibiotic therapy provided sepsis had clinically remitted.</p><p><strong>Exclusions: </strong><i>Staphylococcus aureus</i> or fungal sepsis, and infections requiring prolonged antibiotics. We planned to enrol 350 per group, assuming 10% rate of primary outcome, +7% non-inferiority margin, one-sided 5% alpha, 90% power, 10% loss to follow-up.</p><p><strong>Intervention: </strong>7 days (no further treatment); comparison: 14 days (7 days postrandomisation).</p><p><strong>Outcomes: </strong>Primary: relapse (definite or probable) within day 21 postantibiotic completion.</p><p><strong>Secondary outcomes: </strong>composite of mortality or definite/probable/secondary sepsis and duration of hospitalisation. One interim analysis (per protocol (PP)) was planned.</p><p><strong>Results: </strong>126 and 135 subjects were recruited in 7-day and 14-day groups, respectively, with mean (SD) birth weight (BW) 2250.9 (741.1) and 2187.8 (718.8) g. The trial was terminated early, based on interim PP analysis. 2/125 and 6/130 subjects had the primary outcome in 7-day and 14-day groups, respectively (risk difference (RD)=-3.0% (99.5% CI -9.2%, +3.1%), below non-inferiority margin). The composite secondary outcome also favoured the 7-day regimen (RD: -3.7% (99.5% CI -12.4% to +5.1%)). Duration of hospitalisation was shorter in 7-day group (median difference: -4 days (95% CI -5 to -3)).</p><p><strong>Conclusions: </strong>A 7-day course of antibiotics may be non-inferior to a 14-day course for uncomplicated bacterial neonatal sepsis.</p><p><strong>Trial registration number: </strong>NCT03280147.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"586-594"},"PeriodicalIF":3.6,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143964309","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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: 10.1136/archdischild-2024-327643
Axel R Franz, Corinna Engel, Dirk Bassler, Mario Rüdiger, Ulrich H Thome, Rolf F Maier, Ingeborg Krägeloh-Mann, Jochen Essers, Christoph Bührer, Hans-Jörg Bittrich, Claudia Roll, Thomas Höhn, Harald Ehrhardt, Ralf Boettger, Hans Thorsten Körner, Anja Stein, Patrick Neuberger, Tine Brink Henriksen, Gorm Greisen, Christian F Poets
Objectives: To compare the effect of liberal versus restrictive transfusion strategies on the proportion of time (%time) spent with intermittent hypoxaemia (IH, ie, arterial haemoglobin oxygen saturation measured by pulse oximetry (SpO2) <80% lasting ≥60 s) in the 'Effects of Transfusion Thresholds on Neurocognitive Outcome' (ETTNO) population, and to investigate whether infants with above-median exposure to IH might benefit more from liberal transfusion strategies than those with lower exposure.
Design, setting, patients: Secondary analysis in all 554/1013 infants of <1000 g birth weight recruited into the ETTNO trial (mean gestational age 26.2 weeks) with >80% completeness of SpO2 recordings during postnatal days 8-49.
Intervention: Randomly assigned liberal (n=268) or restrictive (n=286) transfusion strategies, defining transfusion triggers based on postnatal age and health status.
Main outcome measures: %time with IH, rate and mean duration of IH episodes during postnatal days 8-49. Interaction between exposure to IH and transfusion strategies with respect to ETTNO's composite primary outcome, death or disability at 24 months corrected age.
Results: The median (quartile 1-quartile 3) %time with IH was similar between treatment groups (0.91% (0.13%-2.83%) with liberal vs 0.79% (0.16%-2.44%) with restrictive transfusions). There was no interaction between exposure to IH and transfusion strategies on outcome at 24 months.
Conclusions: In infants <1000 g birth weight, a liberal transfusion strategy did not reduce IH. Blood transfusions should not be administered 'liberally' to reduce IH or to improve neurocognitive outcome in infants with above-average exposure to IH.
{"title":"Effects of liberal versus restrictive transfusion strategies on intermittent hypoxaemia in extremely low birthweight infants: secondary analyses of the ETTNO randomised controlled trial.","authors":"Axel R Franz, Corinna Engel, Dirk Bassler, Mario Rüdiger, Ulrich H Thome, Rolf F Maier, Ingeborg Krägeloh-Mann, Jochen Essers, Christoph Bührer, Hans-Jörg Bittrich, Claudia Roll, Thomas Höhn, Harald Ehrhardt, Ralf Boettger, Hans Thorsten Körner, Anja Stein, Patrick Neuberger, Tine Brink Henriksen, Gorm Greisen, Christian F Poets","doi":"10.1136/archdischild-2024-327643","DOIUrl":"10.1136/archdischild-2024-327643","url":null,"abstract":"<p><strong>Objectives: </strong>To compare the effect of liberal versus restrictive transfusion strategies on the proportion of time (%time) spent with intermittent hypoxaemia (IH, ie, arterial haemoglobin oxygen saturation measured by pulse oximetry (SpO<sub>2</sub>) <80% lasting ≥60 s) in the 'Effects of Transfusion Thresholds on Neurocognitive Outcome' (ETTNO) population, and to investigate whether infants with above-median exposure to IH might benefit more from liberal transfusion strategies than those with lower exposure.</p><p><strong>Design, setting, patients: </strong>Secondary analysis in all 554/1013 infants of <1000 g birth weight recruited into the ETTNO trial (mean gestational age 26.2 weeks) with >80% completeness of SpO<sub>2</sub> recordings during postnatal days 8-49.</p><p><strong>Intervention: </strong>Randomly assigned liberal (n=268) or restrictive (n=286) transfusion strategies, defining transfusion triggers based on postnatal age and health status.</p><p><strong>Main outcome measures: </strong>%time with IH, rate and mean duration of IH episodes during postnatal days 8-49. Interaction between exposure to IH and transfusion strategies with respect to ETTNO's composite primary outcome, death or disability at 24 months corrected age.</p><p><strong>Results: </strong>The median (quartile 1-quartile 3) %time with IH was similar between treatment groups (0.91% (0.13%-2.83%) with liberal vs 0.79% (0.16%-2.44%) with restrictive transfusions). There was no interaction between exposure to IH and transfusion strategies on outcome at 24 months.</p><p><strong>Conclusions: </strong>In infants <1000 g birth weight, a liberal transfusion strategy did not reduce IH. Blood transfusions should not be administered 'liberally' to reduce IH or to improve neurocognitive outcome in infants with above-average exposure to IH.</p><p><strong>Trial registration number: </strong>NCT01393496.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"564-570"},"PeriodicalIF":3.6,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12573360/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143727642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-17DOI: 10.1136/archdischild-2024-328337
Prathamesh Khedkar, Abhishek Srinivas, Haribalakrishna Balasubramanian, Mayuri Bhanushali, Anitha Ananthan, Diwakar Mohan, Nandkishore Kabra, Shripada C Rao, Sanjay K Patole
Objective: To evaluate the effect of minimising blood sampling losses on red blood cell (RBC) transfusion-related outcomes in preterm infants <37 weeks' gestation.
Study design: We searched PubMed, Embase, Web of Science and Google Scholar from inception to October 2024 for studies that evaluated sampling stewardship practices (SSP) in preterm infants during initial hospitalisation. Two authors independently screened articles that evaluated one or more sampling approaches to minimise blood loss or non-invasive methods to avoid sampling losses. Meta-analysis was conducted using a random effects model.
Results: Eighteen studies (4 randomised controlled trials (RCTs) and 14 non-randomised studies) were included. Five studies used umbilical cord blood sampling, four used protocol-based sampling and two used retransfusion of sampled blood back to the infant as an SSP. Sampling care bundles were used in seven studies. Meta-analysis showed that SSP reduced early RBC transfusion rates (RCTs: Relative risk(RR) =0.50, 95% CI 0.36, 0.68; non-RCTs: RR=0.78, 95% CI 0.69, 0.90), the average number of transfusions per infant (RCTs: mean difference=-0.4 transfusions, 95% CI -0.68, -0.05; non-RCTs: standardised mean difference=-0.40, 95% CI -0.55, -0.25) and the rates of multiple transfusions (non-RCTs: RR=0.51, 95% CI 0.42, 0.62). There were no significant effects on mortality and other morbidities. Certainty of evidence was high for transfusion-related outcomes and moderate for other outcomes.
Conclusion: SSPs are associated with a significant reduction in RBC transfusion rates among very and extremely preterm infants. Large RCTs are required to assess the effects of SSP on other important outcomes.
Prospero registration number: CRD42024539665.
研究设计:我们检索了PubMed、Embase、Web of Science和谷歌Scholar,从一开始到2024年10月,检索了评估早产儿初次住院期间抽样管理实践(SSP)的研究。两位作者独立筛选了评估一种或多种采样方法以减少失血或非侵入性方法以避免采样损失的文章。采用随机效应模型进行meta分析。结果:纳入18项研究(4项随机对照试验(RCTs)和14项非随机对照研究)。五项研究使用脐带血采样,四项使用基于方案的采样,两项使用将采样血液重新输回婴儿作为SSP。在7项研究中使用了抽样护理包。荟萃分析显示,SSP降低了早期红细胞输血率(rct:相对危险度(RR) =0.50, 95% CI 0.36, 0.68;非rct: RR=0.78, 95% CI 0.69, 0.90),每个婴儿的平均输血次数(rct:平均差异=-0.4次输血,95% CI -0.68, -0.05;非rct:标准化平均差=-0.40,95% CI -0.55, -0.25)和多次输血率(非rct: RR=0.51, 95% CI 0.42, 0.62)。对死亡率和其他发病率没有显著影响。输血相关结果的证据确定性高,其他结果的证据确定性中等。结论:ssp与非常早产儿和极早产儿红细胞输血率显著降低有关。需要大型随机对照试验来评估SSP对其他重要结果的影响。普洛斯彼罗注册号:CRD42024539665。
{"title":"Minimisation of blood sampling losses in preterm neonates: a systematic review and meta-analysis.","authors":"Prathamesh Khedkar, Abhishek Srinivas, Haribalakrishna Balasubramanian, Mayuri Bhanushali, Anitha Ananthan, Diwakar Mohan, Nandkishore Kabra, Shripada C Rao, Sanjay K Patole","doi":"10.1136/archdischild-2024-328337","DOIUrl":"10.1136/archdischild-2024-328337","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the effect of minimising blood sampling losses on red blood cell (RBC) transfusion-related outcomes in preterm infants <37 weeks' gestation.</p><p><strong>Study design: </strong>We searched PubMed, Embase, Web of Science and Google Scholar from inception to October 2024 for studies that evaluated sampling stewardship practices (SSP) in preterm infants during initial hospitalisation. Two authors independently screened articles that evaluated one or more sampling approaches to minimise blood loss or non-invasive methods to avoid sampling losses. Meta-analysis was conducted using a random effects model.</p><p><strong>Results: </strong>Eighteen studies (4 randomised controlled trials (RCTs) and 14 non-randomised studies) were included. Five studies used umbilical cord blood sampling, four used protocol-based sampling and two used retransfusion of sampled blood back to the infant as an SSP. Sampling care bundles were used in seven studies. Meta-analysis showed that SSP reduced early RBC transfusion rates (RCTs: Relative risk(RR) =0.50, 95% CI 0.36, 0.68; non-RCTs: RR=0.78, 95% CI 0.69, 0.90), the average number of transfusions per infant (RCTs: mean difference=-0.4 transfusions, 95% CI -0.68, -0.05; non-RCTs: standardised mean difference=-0.40, 95% CI -0.55, -0.25) and the rates of multiple transfusions (non-RCTs: RR=0.51, 95% CI 0.42, 0.62). There were no significant effects on mortality and other morbidities. Certainty of evidence was high for transfusion-related outcomes and moderate for other outcomes.</p><p><strong>Conclusion: </strong>SSPs are associated with a significant reduction in RBC transfusion rates among very and extremely preterm infants. Large RCTs are required to assess the effects of SSP on other important outcomes.</p><p><strong>Prospero registration number: </strong>CRD42024539665.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"532-541"},"PeriodicalIF":3.6,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143555701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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: 10.1136/archdischild-2025-328577
Vix Monnelly, Firdose Nakwa, Justin B Josephsen, Georg M Schmölzer, Anne Lee Solevåg, Yacov Rabi, Myra H Wyckoff, Gary M Weiner, Helen G Liley
Objective: During perinatal transition, compromised cerebral oxygenation may contribute to neonatal morbidity and mortality. Near-infrared spectroscopy measures cerebral regional tissue oxygen saturations (crSO2) and may guide delivery room respiratory management. This review evaluated whether crSO2 monitoring in addition to routine assessment (clinical assessment, pulse oximetry +/- ECG) compared with routine assessment alone improves neonatal outcomes.
Design: Systematic review and meta-analysis based on Ovid MEDLINE, Embase, and Cochrane CENTRAL searches (16 February and 5 November 2024).
Setting: Delivery room.
Patients: Newborn infants of all gestations, born via any mode, receiving continuous positive airway pressure and/or intermittent positive pressure ventilation during stabilisation/resuscitation.
Intervention: crSO2 monitoring with a dedicated treatment guideline in addition to routine assessment compared with routine assessment alone.
Main outcome measures: Survival without neurodevelopmental impairment, survival, severe intraventricular haemorrhage and periventricular leukomalacia (infants <34 weeks); and crSO2 <10th percentile.
Results: Among 566 articles, 3 articles reporting outcomes from 2 randomised controlled trials (RCTs) (667 preterm infants) were identified. No data were found for survival without neurodevelopmental impairment. We could not exclude benefit or harm from delivery room monitoring of crSO2 for survival (relative risk (RR) 1.02, 95% CI 0.99 to 1.05), severe intraventricular haemorrhage (RR 0.76, 95% CI 0.38 to 1.54), periventricular leukomalacia (RR 1.93, 95% CI 0.66 to 5.70) (n=667; two RCTs) and crSO2 <10th percentile (RR 1.00, 95% CI 0.78 to 1.29) (n=60; one RCT).
Conclusions: The limited evidence could not exclude benefit or harm from delivery room monitoring of crSO2 with a dedicated treatment guideline in preterm infants.
目的:围产期过渡期间,脑氧合受损可能导致新生儿发病率和死亡率。近红外光谱测量大脑区域组织氧饱和度(crSO2),可以指导产房呼吸管理。本综述评估了常规评估(临床评估、脉搏血氧仪+/-心电图)之外的crSO2监测与常规评估相比是否能改善新生儿结局。设计:基于Ovid MEDLINE, Embase和Cochrane CENTRAL检索的系统评价和荟萃分析(2024年2月16日和11月5日)。地点:产房。患者:所有妊娠期的新生儿,通过任何方式出生,在稳定/复苏期间接受持续气道正压通气和/或间歇正压通气。干预措施:在常规评估的基础上进行crSO2监测与单独常规评估的比较。主要结局指标:无神经发育障碍的生存期、生存期、严重脑室内出血和脑室周围白质软化症(婴儿)。结果:在566篇文章中,有3篇文章报告了来自2项随机对照试验(rct)(667名早产儿)的结局。未发现无神经发育障碍存活的数据。我们不能排除产房监测crSO2对生存的益处或危害(相对风险(RR) 1.02, 95% CI 0.99 ~ 1.05)、严重脑室内出血(RR 0.76, 95% CI 0.38 ~ 1.54)、脑室周围白质软化(RR 1.93, 95% CI 0.66 ~ 5.70) (n=667;结论:有限的证据不能排除产房监测crSO2与专门的早产儿治疗指南的利弊。
{"title":"Near-infrared spectroscopy during respiratory support at birth: a systematic review.","authors":"Vix Monnelly, Firdose Nakwa, Justin B Josephsen, Georg M Schmölzer, Anne Lee Solevåg, Yacov Rabi, Myra H Wyckoff, Gary M Weiner, Helen G Liley","doi":"10.1136/archdischild-2025-328577","DOIUrl":"10.1136/archdischild-2025-328577","url":null,"abstract":"<p><strong>Objective: </strong>During perinatal transition, compromised cerebral oxygenation may contribute to neonatal morbidity and mortality. Near-infrared spectroscopy measures cerebral regional tissue oxygen saturations (crSO<sub>2</sub>) and may guide delivery room respiratory management. This review evaluated whether crSO<sub>2</sub> monitoring in addition to routine assessment (clinical assessment, pulse oximetry +/- ECG) compared with routine assessment alone improves neonatal outcomes.</p><p><strong>Design: </strong>Systematic review and meta-analysis based on Ovid MEDLINE, Embase, and Cochrane CENTRAL searches (16 February and 5 November 2024).</p><p><strong>Setting: </strong>Delivery room.</p><p><strong>Patients: </strong>Newborn infants of all gestations, born via any mode, receiving continuous positive airway pressure and/or intermittent positive pressure ventilation during stabilisation/resuscitation.</p><p><strong>Intervention: </strong>crSO<sub>2</sub> monitoring with a dedicated treatment guideline in addition to routine assessment compared with routine assessment alone.</p><p><strong>Main outcome measures: </strong>Survival without neurodevelopmental impairment, survival, severe intraventricular haemorrhage and periventricular leukomalacia (infants <34 weeks); and crSO<sub>2</sub> <10th percentile.</p><p><strong>Results: </strong>Among 566 articles, 3 articles reporting outcomes from 2 randomised controlled trials (RCTs) (667 preterm infants) were identified. No data were found for survival without neurodevelopmental impairment. We could not exclude benefit or harm from delivery room monitoring of crSO<sub>2</sub> for survival (relative risk (RR) 1.02, 95% CI 0.99 to 1.05), severe intraventricular haemorrhage (RR 0.76, 95% CI 0.38 to 1.54), periventricular leukomalacia (RR 1.93, 95% CI 0.66 to 5.70) (n=667; two RCTs) and crSO<sub>2</sub> <10th percentile (RR 1.00, 95% CI 0.78 to 1.29) (n=60; one RCT).</p><p><strong>Conclusions: </strong>The limited evidence could not exclude benefit or harm from delivery room monitoring of crSO<sub>2</sub> with a dedicated treatment guideline in preterm infants.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"602-609"},"PeriodicalIF":3.6,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143957324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}