Nuwellis儿童超滤多中心研究刊于《儿科肾脏病学》：七家儿童医院91名患儿，87%存活完成治疗
医疗科技公司Nuwellis（纳斯达克代码：NUWE，总部位于明尼苏达州明尼阿波利斯）10月27日宣布，其ULTRA-Peds登记研究结果已发表于《儿科肾脏病学》（Pediatric Nephrology），为该公司Aquadex SmartFlow超滤系统在儿童患者中的应用提供多中心临床证据。
该研究汇总了七家儿童医院共91名接受Aquadex治疗的患儿数据，其中62%的患儿体重不足10公斤，包括41名体重不足5公斤的婴儿。结果显示，87%的患儿存活完成其治疗疗程，86.5%的治疗程序无中断完成。论文第一作者米歇尔·C·斯塔尔（Michelle C. Starr）医生表示，这项登记研究汇集了七家儿童医院的临床经验，为体重最小、最脆弱的患儿群体提供了真实世界证据。
该研究由Nuwellis通过资助急性肾损伤重症研究基金会开展，公司未参与数据分析与结果发表。今年早些时候，Nuwellis已与美国食品药品管理局（FDA）完成预提交会议，寻求将Aquadex的适用标签从体重20公斤及以上扩展至5公斤及以上。
Nuwellis Multicenter Pediatric Aquadex Study Published in Pediatric Nephrology: 91 Children at Seven Hospitals, 87% Survived Their Treatment Course
Medical technology company Nuwellis (Nasdaq: NUWE), based in Minneapolis, Minnesota, announced on October 27 that results from its ULTRA-Peds Registry have been published in Pediatric Nephrology, providing multicenter clinical evidence for its Aquadex SmartFlow ultrafiltration system in pediatric patients.
The study pooled data on 91 children treated with Aquadex at seven children's hospitals; 62% weighed less than 10 kilograms, including 41 infants under 5 kilograms. Results showed 87% of patients survived their treatment course and 86.5% of procedures were completed without interruption. First author Dr. Michelle C. Starr said the registry brings together clinical experience from seven children's hospitals and provides real-world evidence for some of the smallest and most vulnerable patients.
The study was funded by Nuwellis through a grant to the Acute Kidney Injury Critical Care Research Foundation, and the company had no input into the data analysis or publication. Earlier this year, Nuwellis completed a pre-submission meeting with the U.S. Food and Drug Administration seeking to expand Aquadex's cleared labeling from patients weighing 20 kilograms and above to those weighing 5 kilograms and above.
来源：GSM·美国（原文链接）
图片来源：医护人员为婴儿做检查（资料图）。图片：Joseph A. Boomhower，美国海军，公共领域，经Wikimedia Commons。 / A medical officer examines an infant (file photo). Photo: Joseph A. Boomhower, U.S. Navy, public domain, via Wikimedia Commons.
