Assessment of infant position and timing of stylet removal to improve lumbar puncture success in neonates (NeoCLEAR) an open-label, 2 ? 2 factorial, randomised, controlled trial
Assessment of infant position and timing of stylet removal to improve lumbar puncture success in neonates (NeoCLEAR) an open-label, 2 ? 2 factorial, randomised, controlled trial
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DOI：
10.1016/s2352-4642(22)00343-1
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发表时间：
2023-01-23
影响因子：
36.4
通讯作者：
NeoCLEAR Collaborative Group
中科院分区：
文献类型：
--
作者：
Marshall, Andrew S. J.;Scrivens, Alexandra;NeoCLEAR Collaborative Group
背景新生儿是细菌性脑膜炎的高危年龄组。因此，腰椎穿刺经常在新生儿中进行，但成功率很低（50-60%）。新生儿每次香槟腰穿-随机对照试验（NeoCLEAR），我们试图通过评估对传统技术的两项改进来优化婴儿腰椎穿刺：坐位与躺下和早期取出管芯针方法NeoCLEAR是一项开放标签、2 × 2析因、随机、对照试验，在21个英国新生儿和产科单位进行。使用24/7、基于网络的安全中心随机化系统，将校正胎龄为27`0至44`0周、体重为1000 g或以上、需要进行腰椎穿刺的婴儿随机分配（1：1：1：1）至坐位和早期探针取出组、坐位和晚期探针取出组、卧位和早期探针取出组或卧位和晚期探针取出组。按照校正胎龄（27`0至31`6周、32`0至36`6周、37`0至40`6周或41`0至44`0周）在研究中心内对区组随机化进行分层，使用4和8个可变区组大小，频率相同。实验室工作人员对分配设盲。主要结果是首次腰椎穿刺成功，定义为获得红细胞计数低于10 000个细胞/μ L的脑脊液样本。按婴儿分配的组分析主要和次要（包括安全性）结局，无论是否偏离方案或收到的分配，但排除在数据收集前退出或未接受腰椎穿刺的婴儿（改良的意向治疗分析）。该研究已在ISRCTN注册，ISRCTN 14040914。研究结果在2018年8月3日至2020年8月31日期间，1082名婴儿被随机分配至坐位（n=546）或卧位（n=536），以及早期（n=549）或晚期（n=533）探针移除。1076名婴儿被随访至出院，并纳入改良的意向治疗分析。961例（89%）婴儿为足月儿，936例（87%）婴儿小于3天。首次腰椎穿刺成功率在坐位比卧位更常见（346/543 [63个中心点7%] vs 307/533 [57个中心点6%];校正风险比1个中心点10 [95% CI 1个中心点01至1个中心点21]，p=0个中心点029;需要治疗的人数=16）。取出探针的时间对主要结局没有明显影响（早期取出管芯针组545名婴儿中有338名[62个中心点0%]，晚期取出管芯针组531名婴儿中有315名[59个中心点3%]，首次腰椎穿刺成功;校正风险比1中心点04 [95%CI 0中心点94-1中心点15]，p=0中心点45）。与躺着相比，坐着时的血氧饱和度下降较少（首次腰椎穿刺时的中位最低血氧饱和度为93% [IQR 89-96] vs 90% [85-94];中位差异为3个中心点0% [2个中心点1-3个中心点9]，p
Background Newborn infants are the highest-risk age group for bacterial meningitis. Lumbar punctures are therefore frequently performed in neonates, but success rates are low (50-60%). In Neonatal Champagne Lumbar punctures Every time-A Randomised Controlled Trial (NeoCLEAR), we sought to optimise infant lumbar puncture by evaluating two modifications to traditional technique: sitting position versus lying down and early stylet removal (stylet removal after transecting the subcutaneous tissue) versus late stylet removal.Methods NeoCLEAR was an open-label, 2 x 2 factorial, randomised, controlled trial, conducted in 21 UK neonatal and maternity units. Infants requiring lumbar puncture at 27`0 to 44`0 weeks corrected gestational age and weighing 1000 g or more were randomly assigned (1:1:1:1) to sitting position and early stylet removal, sitting position and late stylet removal, lying position and early stylet removal, or lying position and late stylet removal using a 24/7, web-based, secure, central randomisation system. Block randomisation was stratified within site by corrected gestational age (27`0 to 31`6 weeks, 32`0 to 36`6 weeks, 37`0 to 40`6 weeks, or 41`0 to 44`0 weeks), using variable block sizes of four and eight with equal frequency. Laboratory staff were masked to allocation. The primary outcome was successful first lumbar puncture, defined as obtaining a cerebrospinal fluid sample with a red blood cell count of less than 10 000 cells per mu L. The primary and secondary (including safety) outcomes were analysed by the groups to which infants were assigned regardless of deviation from the protocol or allocation received, but with exclusion of infants who were withdrawn before data collection or who did not undergo lumbar puncture (modified intention-to-treat analysis). This study is registered with ISRCTN, ISRCTN14040914.Findings Between Aug 3, 2018, and Aug 31, 2020, 1082 infants were randomly assigned to sitting (n=546) or lying (n=536), and early (n=549) or late (n=533) stylet removal. 1076 infants were followed-up until discharge and included in the modified intention-to-treat analysis. 961 (89%) infants were term, and 936 (87%) were younger than 3 days. Successful first lumbar puncture was more frequently observed in sitting than in lying position (346 [63 center dot 7%] of 543 vs 307 [57 center dot 6%] of 533; adjusted risk ratio 1 center dot 10 [95% CI 1 center dot 01 to 1 center dot 21], p=0 center dot 029; number needed to treat=16). Timing of stylet removal had no discernible effect on the primary outcome (338 [62 center dot 0%] of 545 infants in the early stylet removal group and 315 [59 center dot 3%] of 531 in the late stylet removal group had a successful first lumbar puncture; adjusted risk ratio 1 center dot 04 [95% CI 0 center dot 94-1 center dot 15], p=0 center dot 45). Sitting was associated with fewer desaturations than was lying (median lowest oxygen saturations during first lumbar puncture 93% [IQR 89-96] vs 90% [85-94]; median difference 3 center dot 0% [2 center dot 1-3 center dot 9], p