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极低出生体重儿脐静脉导管留置8 - 14天与1 - 7天的评估(UVC - 你将会看到):一项单中心试点随机对照试验

Assessment of an umbilical venous catheter dwell-time of 8-14 days versus 1-7 days in very low birth weight infacts (UVC - You Will See): a pilot single-center, randomized controlled trial.

作者信息

Hess Steffi, Poryo Martin, Ruckes Christian, Papan Cihan, Ehrlich Anne, Ebrahimi-Fakhari Daniel, Bay Johannes Saaradonna, Wagenpfeil Stefan, Simon Arne, Meyer Sascha

机构信息

Saarland University Medical Center, Department of General Pediatrics and Neonatology, Homburg, Germany.

Saarland University Medical Center, Department of Pediatric Cardiology, Homburg, Germany.

出版信息

Early Hum Dev. 2023 Apr;179:105752. doi: 10.1016/j.earlhumdev.2023.105752. Epub 2023 Mar 17.

Abstract

BACKGROUND

Umbilical venous catheters (UVCs) are used for central vascular access in preterm infants, but controversy exits with regard to the optimum dwell-time.

PATIENTS AND METHODS

Prospective, randomized controlled trial at a level III University neonatal intensive care unit (NICU), comparing a UVC dwell-time of 1-7 days (control group) to 8-14 days (intervention group) in very low birth weight (VLBW) infants.

PRIMARY OUTCOME PARAMETER

Number of infants requiring additional peripherally inserted central catheters (PICC) after removal of UVC.

SECONDARY OUTCOME PARAMETERS

Total number of central lines (CL = UVC and PICCs) until time point of full enteral feeds (130-160 mL/kg/d), total number of intravenous vascular catheters, number of CL-associated complications (infection, thrombosis/emboli, organ injury, secondary CL dislocation), number of X-rays for assessment of CL positioning, and days of therapy (DOT) (teicoplanin) for CL-associated blood stream infections (CLABSI).

RESULTS

Of 116 patients screened for eligibility, 63 patients were enrolled - control group: 31 infants, mean gestational age (GA) 28 weeks (standard deviation (SD) 2.6 weeks), mean birth weight (BW) 988.9 g (SD 322.0 g); intervention group: 32 infants, mean GA 28 weeks (SD 3.0 weeks), mean BW 1078.9 g (SD 324.6 g). In the control group, 28 infants required additional PICCs versus 16 in the intervention group (p < 0.001); total number of CLs: control group n = 58 versus intervention group n = 28; p < 0.001, and the total number of venous vascular devices was also significantly higher in the control group (109 versus 61; p = 0.04). No significant differences were seen with regard to CL-associated complications (p = 0.09). The number of X-rays for assessment of correct CL-position significantly lower in the intervention group (144 versus 96; p = 0.03). In the intervention group, length of hospital stay was significantly shorter (88.1 (SD: 35.3 days) versus 68.1 (SD: 32.6 days); p = 0.03) and GA significantly lower at discharge from the hospital (40: SD: 3 weeks) versus 38: SD: 2 weeks; p = 0.02. No differences existed with regard to neonatal morbidities and mortality at 36 weeks gestational age.

CONCLUSIONS

A longer UVC dwell-time of up to 14 days significantly decreased the number of painful invasive vascular procedures and radiation exposure, and shortened the length of the hospital stay. The findings of our pilot study should be confirmed in a larger, multi-center RCT with the primary focus on catheter-associated complications.

摘要

背景

脐静脉导管(UVC)用于早产儿的中心血管通路,但关于最佳留置时间存在争议。

患者与方法

在一所三级大学新生儿重症监护病房(NICU)进行前瞻性随机对照试验,比较极低出生体重(VLBW)婴儿中UVC留置时间为1 - 7天(对照组)与8 - 14天(干预组)的情况。

主要结局参数

UVC拔除后需要额外置入外周中心静脉导管(PICC)的婴儿数量。

次要结局参数

直至完全经口喂养时间点(130 - 160 mL/kg/d)时中心静脉导管(CL = UVC和PICC)的总数、静脉血管导管的总数、CL相关并发症的数量(感染、血栓形成/栓塞、器官损伤、继发性CL移位)、用于评估CL位置的X线检查次数以及CL相关血流感染(CLABSI)的治疗天数(DOT)(替考拉宁)。

结果

在116例筛查合格的患者中,63例患者入组——对照组:31例婴儿,平均胎龄(GA)28周(标准差(SD)2.6周),平均出生体重(BW)988.9 g(SD 322.0 g);干预组:32例婴儿,平均GA 28周(SD 3.0周),平均BW 1078.9 g(SD 324.6 g)。对照组中,28例婴儿需要额外置入PICC,而干预组为16例(p < 0.001);CL总数:对照组n = 58,干预组n = 28;p < 0.001,且对照组静脉血管装置的总数也显著更高(109对61;p = 0.04)。在CL相关并发症方面未见显著差异(p = 0.09)。干预组中用于评估CL正确位置的X线检查次数显著更低(144对96;p = 0.03)。干预组的住院时间显著更短(88.1(SD:35.3天)对68.1(SD:32.6天);p = 0.03),出院时的GA显著更低(40:SD:3周)对38:SD:2周;p = 0.02。在孕36周时新生儿发病率和死亡率方面无差异。

结论

长达14天的较长UVC留置时间显著减少了痛苦的有创血管操作次数和辐射暴露,并缩短了住院时间。我们的初步研究结果应在一项更大规模的多中心随机对照试验中得到证实,该试验主要关注导管相关并发症。

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