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研究草案:“UVC-你将看到”研究:极早产儿(出生体重 < 1250 克和/或胎龄 < 30 周)中较长与较短脐静脉导管(UVC)留置时间(6-10 天与 1-5 天)。

Study draft: "UVC-You Will See" study: longer vs. shorter umbilical venous catheter (UVC) dwell time (6-10 vs. 1-5 days) in very premature infants with birth weight < 1250 g and/or gestational age < 30 weeks.

机构信息

Department of Pediatrics and Neonatology, University Hospital Saarland, Homburg, Germany.

Kinder- und Jugendmedizin, Klinikum Saarbrücken Winterberg, Saarbrücken, Germany.

出版信息

Wien Med Wochenschr. 2024 Sep;174(11-12):217-224. doi: 10.1007/s10354-024-01047-7. Epub 2024 Jun 13.

DOI:10.1007/s10354-024-01047-7
PMID:38869762
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11347460/
Abstract

BACKGROUND

Umbilical venous catheters (UVCs) are often used in preterm infants. Their use is associated with complications (infections, clot formation, organ injury). Very preterm infants with acquired bloodstream infection are at a higher risk for death and important morbidities (e.g., adverse neurodevelopmental outcomes). It is standard clinical practice to remove UVCs in the first days of life. Replacement of intravenous access is often performed using percutaneously inserted central catheters (PICCs). It is unclear whether serial central line use affects the rates of catheter-related complications.

METHODS

A multicenter randomized controlled trial (random group assignment) was performed in 562 very premature (gestational age < 30 weeks) and/or very low birth weight infants (< 1250 g) requiring an UVC for administration of parenteral nutrition and/or drugs. Group allocation was random.

HYPOTHESIS

A UVC dwell time of 6-10 days (281 infants) is not associated with an increased rate of central venous catheter (UVC, PICC)-related complications compared to 1-5 days (281 infants), and a longer UVC dwell time will significantly reduce the number of painful, invasive procedures associated with the need for vascular access as well as radiation exposure, use of antibiotics, and medical costs.

PRIMARY OUTCOME PARAMETER

The number of catheter-related bloodstream infections and/or catheter-related thromboses and/or catheter-associated organ injuries related to the use of UVC/PICC was the primary outcome.

CONCLUSION

Extending the UVC dwell time may significantly reduce the number of painful invasive procedures, with the potential to positively impact not only long-term pain perception but also important social competencies (attention, learning, and behavior). Thus, the "UVC-You Will See" study has the potential to substantially change current neonatal intensive care practice.

摘要

背景

脐静脉导管(UVC)常用于早产儿。其使用与并发症(感染、血栓形成、器官损伤)有关。患有获得性血流感染的极早产儿死亡和发生重要并发症(如不良神经发育结局)的风险更高。在生命的最初几天内移除 UVC 是标准的临床实践。静脉内通路的更换通常通过经皮插入中心导管(PICC)进行。目前尚不清楚连续使用中心静脉导管是否会影响导管相关并发症的发生率。

方法

一项多中心随机对照试验(随机分组)在 562 名需要 UVC 进行肠外营养和/或药物治疗的极早产儿(<30 周的胎龄)和/或极低出生体重儿(<1250g)中进行。组分配是随机的。

假设

UVC 留置时间为 6-10 天(281 例)与 1-5 天(281 例)相比,并不增加中心静脉导管(UVC、PICC)相关并发症的发生率,较长的 UVC 留置时间将显著减少与血管通路需求相关的疼痛、有创操作的次数,以及减少射线暴露、抗生素使用和医疗费用。

主要结局参数

UVC/PICC 使用相关的血流感染和/或导管相关血栓形成和/或导管相关器官损伤的导管相关并发症的数量是主要结局。

结论

延长 UVC 留置时间可能会显著减少疼痛的有创操作次数,这有可能不仅对长期疼痛感知产生积极影响,而且对重要的社会能力(注意力、学习和行为)产生积极影响。因此,“UVC-You Will See”研究有可能极大地改变当前新生儿重症监护的实践。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7770/11347460/14920a6d6ac1/10354_2024_1047_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7770/11347460/14920a6d6ac1/10354_2024_1047_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7770/11347460/14920a6d6ac1/10354_2024_1047_Fig1_HTML.jpg

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