提高新生儿腰椎穿刺成功率的技术:NeoCLEAR RCT。

IF 3.5 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Charles C Roehr, Andrew Sj Marshall, Alexandra Scrivens, Manish Sadarangani, Rachel Williams, Jean Yong, Louise Linsell, Virginia Chiocchia, Jennifer L Bell, Caz Stokes, Patricia Santhanadass, Ian Nicoll, Eleri Adams, Andrew King, David Murray, Ursula Bowler, Kayleigh Stanbury, Edmund Juszczak
{"title":"提高新生儿腰椎穿刺成功率的技术:NeoCLEAR RCT。","authors":"Charles C Roehr, Andrew Sj Marshall, Alexandra Scrivens, Manish Sadarangani, Rachel Williams, Jean Yong, Louise Linsell, Virginia Chiocchia, Jennifer L Bell, Caz Stokes, Patricia Santhanadass, Ian Nicoll, Eleri Adams, Andrew King, David Murray, Ursula Bowler, Kayleigh Stanbury, Edmund Juszczak","doi":"10.3310/THJY0671","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Lumbar puncture is an essential tool for diagnosing meningitis. Neonatal lumbar puncture, although frequently performed, has low success rates (50-60%). Standard technique includes lying infants on their side and removing the stylet 'late', that is, after the needle is thought to have entered the cerebrospinal fluid. Modifications to this technique include holding infants in the sitting position and removing the stylet 'early', that is, following transection of the skin. To the best of our knowledge, modified techniques have not previously been tested in adequately powered trials.</p><p><strong>Objectives: </strong>The aim of the Neonatal Champagne Lumbar punctures Every time - An RCT (NeoCLEAR) trial was to compare two modifications to standard lumbar puncture technique, that is, use of the lying position rather than the sitting position and of 'early' rather than 'late' stylet removal, in terms of success rates and short-term clinical, resource and safety outcomes.</p><p><strong>Methods: </strong>This was a multicentre 2 × 2 factorial pragmatic non-blinded randomised controlled trial. Infants requiring lumbar puncture (with a working weight ≥ 1000 g and corrected gestational age from 27<sup>+0</sup> to 44<sup>+0</sup> weeks), and whose parents provided written consent, were randomised by web-based allocation to lumbar puncture (1) in the sitting or lying position and (2) with early or late stylet removal. The trial was powered to detect a 10% absolute risk difference in the primary outcome, that is, the percentage of infants with a successful lumbar puncture (cerebrospinal fluid containing < 10,000 red cells/mm<sup>3</sup>). The primary outcome was analysed by modified intention to treat.</p><p><strong>Results: </strong>Of 1082 infants randomised (sitting with early stylet removal, <i>n</i> = 275; sitting with late stylet removal, <i>n</i> = 271; lying with early stylet removal, <i>n</i> = 274; lying with late stylet removal, <i>n</i> = 262), 1076 were followed up until discharge. Most infants were term born (950/1076, 88.3%) and were aged < 3 days (936/1076, 87.0%) with a working weight > 2.5 kg (971/1076, 90.2%). Baseline characteristics were balanced across groups. In terms of the primary outcome, the sitting position was significantly more successful than lying [346/543 (63.7%) vs. 307/533 (57.6%), adjusted risk ratio 1.10 (95% confidence interval 1.01 to 1.21); <i>p</i> = 0.029; number needed to treat = 16 (95% confidence interval 9 to 134)]. There was no significant difference in the primary outcome between early stylet removal and late stylet removal [338/545 (62.0%) vs. 315/531 (59.3%), adjusted risk ratio 1.04 (95% confidence interval 0.94 to 1.15); <i>p</i> = 0.447]. Resource consumption was similar in all groups, and all techniques were well tolerated and safe.</p><p><strong>Limitations: </strong>This trial predominantly recruited term-born infants who were < 3 days old, with working weights > 2.5 kg. The impact of practitioners' seniority and previous experience of different lumbar puncture techniques was not investigated. Limited data on resource use were captured, and parent/practitioner preferences were not assessed.</p><p><strong>Conclusion: </strong>Lumbar puncture success rate was higher with infants in the sitting position but was not affected by timing of stylet removal. Lumbar puncture is a safe, well-tolerated and simple technique without additional cost, and is easily learned and applied. The results support a paradigm shift towards sitting technique as the standard position for neonatal lumbar puncture, especially for term-born infants during the first 3 days of life.</p><p><strong>Future work: </strong>The superiority of the sitting lumbar puncture technique should be tested in larger populations of premature infants, in those aged > 3 days and outside neonatal care settings. The effect of operators' previous practice and the impact on family experience also require further investigation, alongside in-depth analyses of healthcare resource utilisation. Future studies should also investigate other factors affecting lumbar puncture success, including further modifications to standard technique.</p><p><strong>Trial registration: </strong>This trial is registered as ISRCTN14040914 and as Integrated Research Application System registration 223737.</p><p><strong>Funding: </strong>This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/188/106) and is published in full in <i>Health Technology Assessment</i>; Vol. 27, No. 33. See the NIHR Funding and Awards website for further award information.</p>","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":null,"pages":null},"PeriodicalIF":3.5000,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017152/pdf/","citationCount":"0","resultStr":"{\"title\":\"Techniques to increase lumbar puncture success in newborn babies: the NeoCLEAR RCT.\",\"authors\":\"Charles C Roehr, Andrew Sj Marshall, Alexandra Scrivens, Manish Sadarangani, Rachel Williams, Jean Yong, Louise Linsell, Virginia Chiocchia, Jennifer L Bell, Caz Stokes, Patricia Santhanadass, Ian Nicoll, Eleri Adams, Andrew King, David Murray, Ursula Bowler, Kayleigh Stanbury, Edmund Juszczak\",\"doi\":\"10.3310/THJY0671\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Lumbar puncture is an essential tool for diagnosing meningitis. Neonatal lumbar puncture, although frequently performed, has low success rates (50-60%). Standard technique includes lying infants on their side and removing the stylet 'late', that is, after the needle is thought to have entered the cerebrospinal fluid. Modifications to this technique include holding infants in the sitting position and removing the stylet 'early', that is, following transection of the skin. To the best of our knowledge, modified techniques have not previously been tested in adequately powered trials.</p><p><strong>Objectives: </strong>The aim of the Neonatal Champagne Lumbar punctures Every time - An RCT (NeoCLEAR) trial was to compare two modifications to standard lumbar puncture technique, that is, use of the lying position rather than the sitting position and of 'early' rather than 'late' stylet removal, in terms of success rates and short-term clinical, resource and safety outcomes.</p><p><strong>Methods: </strong>This was a multicentre 2 × 2 factorial pragmatic non-blinded randomised controlled trial. Infants requiring lumbar puncture (with a working weight ≥ 1000 g and corrected gestational age from 27<sup>+0</sup> to 44<sup>+0</sup> weeks), and whose parents provided written consent, were randomised by web-based allocation to lumbar puncture (1) in the sitting or lying position and (2) with early or late stylet removal. The trial was powered to detect a 10% absolute risk difference in the primary outcome, that is, the percentage of infants with a successful lumbar puncture (cerebrospinal fluid containing < 10,000 red cells/mm<sup>3</sup>). The primary outcome was analysed by modified intention to treat.</p><p><strong>Results: </strong>Of 1082 infants randomised (sitting with early stylet removal, <i>n</i> = 275; sitting with late stylet removal, <i>n</i> = 271; lying with early stylet removal, <i>n</i> = 274; lying with late stylet removal, <i>n</i> = 262), 1076 were followed up until discharge. Most infants were term born (950/1076, 88.3%) and were aged < 3 days (936/1076, 87.0%) with a working weight > 2.5 kg (971/1076, 90.2%). Baseline characteristics were balanced across groups. In terms of the primary outcome, the sitting position was significantly more successful than lying [346/543 (63.7%) vs. 307/533 (57.6%), adjusted risk ratio 1.10 (95% confidence interval 1.01 to 1.21); <i>p</i> = 0.029; number needed to treat = 16 (95% confidence interval 9 to 134)]. There was no significant difference in the primary outcome between early stylet removal and late stylet removal [338/545 (62.0%) vs. 315/531 (59.3%), adjusted risk ratio 1.04 (95% confidence interval 0.94 to 1.15); <i>p</i> = 0.447]. Resource consumption was similar in all groups, and all techniques were well tolerated and safe.</p><p><strong>Limitations: </strong>This trial predominantly recruited term-born infants who were < 3 days old, with working weights > 2.5 kg. The impact of practitioners' seniority and previous experience of different lumbar puncture techniques was not investigated. Limited data on resource use were captured, and parent/practitioner preferences were not assessed.</p><p><strong>Conclusion: </strong>Lumbar puncture success rate was higher with infants in the sitting position but was not affected by timing of stylet removal. Lumbar puncture is a safe, well-tolerated and simple technique without additional cost, and is easily learned and applied. The results support a paradigm shift towards sitting technique as the standard position for neonatal lumbar puncture, especially for term-born infants during the first 3 days of life.</p><p><strong>Future work: </strong>The superiority of the sitting lumbar puncture technique should be tested in larger populations of premature infants, in those aged > 3 days and outside neonatal care settings. The effect of operators' previous practice and the impact on family experience also require further investigation, alongside in-depth analyses of healthcare resource utilisation. Future studies should also investigate other factors affecting lumbar puncture success, including further modifications to standard technique.</p><p><strong>Trial registration: </strong>This trial is registered as ISRCTN14040914 and as Integrated Research Application System registration 223737.</p><p><strong>Funding: </strong>This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/188/106) and is published in full in <i>Health Technology Assessment</i>; Vol. 27, No. 33. See the NIHR Funding and Awards website for further award information.</p>\",\"PeriodicalId\":12898,\"journal\":{\"name\":\"Health technology assessment\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2023-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017152/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Health technology assessment\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3310/THJY0671\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Health technology assessment","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3310/THJY0671","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0

摘要

背景:腰椎穿刺是诊断脑膜炎的重要工具。新生儿腰椎穿刺虽然经常进行,但成功率很低(50%-60%)。标准技术包括让婴儿侧卧,"晚 "拔出针头,即在认为针头已进入脑脊液后拔出。该技术的改进包括让婴儿保持坐姿,"早期 "拔出针头,即在横切皮肤后拔出针头。据我们所知,改良后的技术以前还没有在充分授权的试验中进行过测试:新生儿每次香槟腰椎穿刺--RCT(NeoCLEAR)试验的目的是比较标准腰椎穿刺技术的两种改进方法,即使用卧位而非坐位,以及 "早期 "而非 "晚期 "拔除针头,以比较成功率以及短期临床、资源和安全结果:这是一项多中心 2 × 2 因式实用非盲随机对照试验。需要进行腰椎穿刺的婴儿(工作体重≥1000克,校正胎龄为27+0周至44+0周),在家长提供书面同意书的情况下,通过网络随机分配进行腰椎穿刺:(1) 坐位或卧位;(2) 早期或晚期取环。该试验的作用是检测主要结果(即腰椎穿刺成功(脑脊液中红细胞含量小于 10,000 个/立方毫米)的婴儿百分比)中 10% 的绝对风险差异。主要结果按修改后的意向治疗进行分析:在随机抽取的 1082 名婴儿中(坐着早期取出支架,n = 275;坐着晚期取出支架,n = 271;躺着早期取出支架,n = 274;躺着晚期取出支架,n = 262),有 1076 名婴儿接受了随访直至出院。大多数婴儿为足月儿(950/1076,88.3%),年龄小于 3 天(936/1076,87.0%),工作体重大于 2.5 千克(971/1076,90.2%)。各组的基线特征均衡。就主要结果而言,坐位的成功率明显高于卧位[346/543(63.7%)vs 307/533(57.6%),调整风险比 1.10(95% 置信区间 1.01 至 1.21);p = 0.029;治疗所需人数 = 16(95% 置信区间 9 至 134)]。在主要结果方面,早期移除支架与晚期移除支架无明显差异[338/545(62.0%)vs 315/531(59.3%),调整后风险比 1.04(95% 置信区间 0.94 至 1.15);p = 0.447]。各组的资源消耗情况相似,所有技术的耐受性和安全性均良好:该试验主要招募出生小于 3 天、工作体重大于 2.5 千克的足月儿。没有调查从业人员的资历和以往使用不同腰椎穿刺技术的经验对试验的影响。有关资源使用的数据有限,也未对家长/从业人员的偏好进行评估:结论:婴儿取坐位时腰椎穿刺成功率较高,但拔出针头的时间并不影响穿刺成功率。腰椎穿刺是一项安全、耐受性好且简单的技术,无需额外费用,易于学习和应用。研究结果支持将坐位技术作为新生儿腰椎穿刺的标准姿势,尤其是对出生后 3 天内的足月儿:未来的工作:坐位腰椎穿刺技术的优越性应在更大的早产儿群体中、年龄大于 3 天的早产儿中以及在新生儿护理环境之外进行测试。此外,还需要进一步调查操作者以往操作的影响以及对家庭体验的影响,并对医疗资源利用情况进行深入分析。未来的研究还应调查影响腰椎穿刺成功率的其他因素,包括对标准技术的进一步修改:本试验注册号为 ISRCTN14040914,综合研究应用系统注册号为 223737:该奖项由美国国家健康与护理研究所(NIHR)健康技术评估项目资助(NIHR奖项编号:15/188/106),全文发表于《健康技术评估》第27卷第33期。更多奖项信息请参阅 NIHR Funding and Awards 网站。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Techniques to increase lumbar puncture success in newborn babies: the NeoCLEAR RCT.

Background: Lumbar puncture is an essential tool for diagnosing meningitis. Neonatal lumbar puncture, although frequently performed, has low success rates (50-60%). Standard technique includes lying infants on their side and removing the stylet 'late', that is, after the needle is thought to have entered the cerebrospinal fluid. Modifications to this technique include holding infants in the sitting position and removing the stylet 'early', that is, following transection of the skin. To the best of our knowledge, modified techniques have not previously been tested in adequately powered trials.

Objectives: The aim of the Neonatal Champagne Lumbar punctures Every time - An RCT (NeoCLEAR) trial was to compare two modifications to standard lumbar puncture technique, that is, use of the lying position rather than the sitting position and of 'early' rather than 'late' stylet removal, in terms of success rates and short-term clinical, resource and safety outcomes.

Methods: This was a multicentre 2 × 2 factorial pragmatic non-blinded randomised controlled trial. Infants requiring lumbar puncture (with a working weight ≥ 1000 g and corrected gestational age from 27+0 to 44+0 weeks), and whose parents provided written consent, were randomised by web-based allocation to lumbar puncture (1) in the sitting or lying position and (2) with early or late stylet removal. The trial was powered to detect a 10% absolute risk difference in the primary outcome, that is, the percentage of infants with a successful lumbar puncture (cerebrospinal fluid containing < 10,000 red cells/mm3). The primary outcome was analysed by modified intention to treat.

Results: Of 1082 infants randomised (sitting with early stylet removal, n = 275; sitting with late stylet removal, n = 271; lying with early stylet removal, n = 274; lying with late stylet removal, n = 262), 1076 were followed up until discharge. Most infants were term born (950/1076, 88.3%) and were aged < 3 days (936/1076, 87.0%) with a working weight > 2.5 kg (971/1076, 90.2%). Baseline characteristics were balanced across groups. In terms of the primary outcome, the sitting position was significantly more successful than lying [346/543 (63.7%) vs. 307/533 (57.6%), adjusted risk ratio 1.10 (95% confidence interval 1.01 to 1.21); p = 0.029; number needed to treat = 16 (95% confidence interval 9 to 134)]. There was no significant difference in the primary outcome between early stylet removal and late stylet removal [338/545 (62.0%) vs. 315/531 (59.3%), adjusted risk ratio 1.04 (95% confidence interval 0.94 to 1.15); p = 0.447]. Resource consumption was similar in all groups, and all techniques were well tolerated and safe.

Limitations: This trial predominantly recruited term-born infants who were < 3 days old, with working weights > 2.5 kg. The impact of practitioners' seniority and previous experience of different lumbar puncture techniques was not investigated. Limited data on resource use were captured, and parent/practitioner preferences were not assessed.

Conclusion: Lumbar puncture success rate was higher with infants in the sitting position but was not affected by timing of stylet removal. Lumbar puncture is a safe, well-tolerated and simple technique without additional cost, and is easily learned and applied. The results support a paradigm shift towards sitting technique as the standard position for neonatal lumbar puncture, especially for term-born infants during the first 3 days of life.

Future work: The superiority of the sitting lumbar puncture technique should be tested in larger populations of premature infants, in those aged > 3 days and outside neonatal care settings. The effect of operators' previous practice and the impact on family experience also require further investigation, alongside in-depth analyses of healthcare resource utilisation. Future studies should also investigate other factors affecting lumbar puncture success, including further modifications to standard technique.

Trial registration: This trial is registered as ISRCTN14040914 and as Integrated Research Application System registration 223737.

Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/188/106) and is published in full in Health Technology Assessment; Vol. 27, No. 33. See the NIHR Funding and Awards website for further award information.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Health technology assessment
Health technology assessment 医学-卫生保健
CiteScore
6.90
自引率
0.00%
发文量
94
审稿时长
>12 weeks
期刊介绍: Health Technology Assessment (HTA) publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信