Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial.
Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial.
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DOI：
10.1136/bmj.g7635
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发表时间：
2015-01-05
期刊：
影响因子：
--
通讯作者：
Greisen G
中科院分区：
文献类型：
--
作者：
Hyttel-Sorensen S;Pellicer A;Alderliesten T;Austin T;van Bel F;Benders M;Claris O;Dempsey E;Franz AR;Fumagalli M;Gluud C;Grevstad B;Hagmann C;Lemmers P;van Oeveren W;Pichler G;Plomgaard AM;Riera J;Sanchez L;Winkel P;Wolf M;Greisen G
目的探讨脑近红外光谱（NIRS）血氧仪监测极早产儿脑氧合的稳定性。设计II期随机、单盲、平行临床试验。设置八个欧洲国家的八个三级新生儿重症监护病房。研究对象：166例妊娠28周前出生的极早产儿：86例随机接受脑NIRS监测，80例接受盲态NIRS监测。唯一的排除标准是决定不提供生命支持。干预在生命的前72小时内使用NIRS结合专用治疗指南监测脑氧合（实验），与使用标准护理的盲态NIRS氧合监测（对照）进行比较。主要结果测量主要结果测量是脑氧合超出55-85%目标范围的时间乘以平均绝对偏差，以%小时表示（缺氧和高氧负荷）。氧合50%一小时，缺氧5%小时。次要结局是足月等效年龄的全因死亡率和通过脑超声检查评估的脑损伤评分。随机化分配顺序为1：1，区组大小为4和6，随机顺序对研究者隐藏。根据胎龄（<26周或≥26周）对分配进行分层。对照组中的脑氧合测量是设盲的。所有结局评估者均对组分配设盲。结果86例随机分配到NIRS组的婴儿中位缺氧和高氧负荷为36.1%小时（四分位数范围9.2- 79.5%小时），而对照组为81.3（38.5-181.3）%小时，减少了58%（95%可信区间35%-73%，P<0.001）。实验组中位缺氧负荷为16.6（四分位距5.4-68.1）%小时，对照组为53.6（17.4-171.3）%小时（P=0.0012）。两组之间的中位高氧负荷相似：实验组为1.2（四分位距0.3-9.6）%小时，对照组为1.1（0.1-23.4）%小时（P=0.98）。我们发现两组在足月矫正年龄方面没有统计学显著差异。没有与器械相关的严重不良反应。结论：采用专门的治疗指南结合脑近红外光谱监测，极早产儿的脑氧合稳定。试用注册ClinicalTrial.gov NCT 01590316。
Objective To determine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants monitored by cerebral near infrared spectroscopy (NIRS) oximetry. Design Phase II randomised, single blinded, parallel clinical trial. Setting Eight tertiary neonatal intensive care units in eight European countries. Participants 166 extremely preterm infants born before 28 weeks of gestation: 86 were randomised to cerebral NIRS monitoring and 80 to blinded NIRS monitoring. The only exclusion criterion was a decision not to provide life support. Interventions Monitoring of cerebral oxygenation using NIRS in combination with a dedicated treatment guideline during the first 72 hours of life (experimental) compared with blinded NIRS oxygenation monitoring with standard care (control). Main outcome measures The primary outcome measure was the time spent outside the target range of 55-85% for cerebral oxygenation multiplied by the mean absolute deviation, expressed in %hours (burden of hypoxia and hyperoxia). One hour with an oxygenation of 50% gives 5%hours of hypoxia. Secondary outcomes were all cause mortality at term equivalent age and a brain injury score assessed by cerebral ultrasonography. Randomisation Allocation sequence 1:1 with block sizes 4 and 6 in random order concealed for the investigators. The allocation was stratified for gestational age (<26 weeks or ≥26 weeks). Blinding Cerebral oxygenation measurements were blinded in the control group. All outcome assessors were blinded to group allocation. Results The 86 infants randomised to the NIRS group had a median burden of hypoxia and hyperoxia of 36.1%hours (interquartile range 9.2-79.5%hours) compared with 81.3 (38.5-181.3) %hours in the control group, a reduction of 58% (95% confidence interval 35% to 73%, P<0.001). In the experimental group the median burden of hypoxia was 16.6 (interquartile range 5.4-68.1) %hours, compared with 53.6 (17.4-171.3) %hours in the control group (P=0.0012). The median burden of hyperoxia was similar between the groups: 1.2 (interquartile range 0.3-9.6) %hours in the experimental group compared with 1.1 (0.1-23.4) %hours in the control group (P=0.98). We found no statistically significant differences between the two groups at term corrected age. No severe adverse reactions were associated with the device. Conclusions Cerebral oxygenation was stabilised in extremely preterm infants using a dedicated treatment guideline in combination with cerebral NIRS monitoring. Trial registration ClinicalTrial.gov NCT01590316.
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