Te Whatu Ora Counties Manukau, New Zealand; Department of Surgery, The University of Auckland, New Zealand; The Insides Company, New Zealand.
The Insides Company, New Zealand; Te Whatu Ora Te Toka Tumai Auckland, New Zealand.
Clin Nutr. 2024 Oct;43(10):2253-2260. doi: 10.1016/j.clnu.2024.08.016. Epub 2024 Aug 21.
Neonatal and pediatric intestinal failure related to enterostomy is an infrequent but burdensome condition associated with substantial morbidity and mortality. This study presents the development and clinical validation of a novel device to resolve these problems, by formalizing a safe and efficient enterostomy chyme reinfusion technique.
A novel neonatal chyme reinfusion device was designed and manufactured ('The Insides Neo', The Insides Company, New Zealand), prior to validation in a feasibility study in tertiary neonatal intensive care centres. Neonates with double enterostomy were recruited and commenced on chyme reinfusion therapy using the novel device to test safety, efficacy, tolerability, and usability within nursing workflows. Device and clinical outcomes were recorded along with nursing feedback. Registered under the ANZCTR, identifier no. ACTRN12621000835842p.
Ten neonates were recruited across two centres, with a median usage duration of 37.5 (range 12-84) days. Following initiation of therapy, rate of weight gain increased from mean 68.8 ± 37.4 to 197 ± 25.0 g/week (p = 0.024). Of the 7/10 neonates on PN at commencement of therapy, 4/7 were able to wean and achieve enteral autonomy. All neonates tolerated the device with uniformly positive nursing feedback and minimal time to learn and incorporate the novel device into nursing workflows. There were no device-related adverse events.
A novel device was developed and validated to be safe and effective at performing chyme reinfusion therapy in neonates. This device is anticipated to improve the clinical care and outcomes of neonatal patients with double enterostomies.
与肠造口相关的新生儿和儿科肠衰竭是一种罕见但负担沉重的疾病，与较高的发病率和死亡率相关。本研究提出了一种新装置的开发和临床验证，通过规范化一种安全有效的肠液再输注技术来解决这些问题。
设计并制造了一种新型的新生儿肠液再输注装置（“The Insides Neo”，The Insides 公司，新西兰），然后在三级新生儿重症监护中心进行了可行性研究进行验证。招募了具有双肠造口的新生儿，并开始使用新型装置进行肠液再输注治疗，以测试安全性、疗效、耐受性和在护理工作流程中的易用性。记录设备和临床结果以及护理反馈。在澳大利亚新西兰临床试验注册中心注册，注册号为 ACTRN12621000835842p。
在两个中心共招募了 10 名新生儿，中位使用时间为 37.5（范围 12-84）天。治疗开始后，体重增加率从平均 68.8±37.4 增加到 197±25.0 g/周（p=0.024）。在开始治疗时接受 PN 的 7/10 名新生儿中，4/7 能够脱机并实现肠内自主。所有新生儿均耐受该设备，护理人员的反馈普遍为正面，且学习和将新型设备纳入护理工作流程的时间很短。无设备相关不良事件。
开发并验证了一种新型装置，用于对新生儿进行肠液再输注治疗是安全有效的。该设备有望改善具有双肠造口的新生儿患者的临床护理和结局。
