Thomale Ulrich-Wilhelm, Cinalli Giuseppe, Kulkarni Abhaya V, Al-Hakim Sara, Roth Jonathan, Schaumann Andreas, Bührer Christoph, Cavalheiro Sergio, Sgouros Spyros, Constantini Shlomi, Bock Hans Christoph
Pediatric Neurosurgery, Campus Virchow Klinikum, Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
Pediatric Neurosurgery, Santobono-Pausilipon Children's Hospital, Naples, Italy.
Childs Nerv Syst. 2019 Apr;35(4):613-619. doi: 10.1007/s00381-019-04077-4. Epub 2019 Feb 6.
Among children with hydrocephalus, neonates with intraventricular hemorrhage (IVH) and posthemorrhagic hydrocephalus (PH) are considered a group with one of the highest complication rates of treatment. Despite continued progress in neonatal care, a standardized and reliable guideline for surgical management is missing for this challenging condition. Thus, further research is warranted to compare common methods of surgical treatment. The introduction of neuroendoscopic lavage has precipitated the establishment of an international registry aimed at elaborating key elements of a standardized surgical treatment.
The registry is designed as a multicenter, international, prospective data collection for neonates aged 41 weeks gestation, with an indication for surgical treatment for IVH with ventricular dilatation and progressive hydrocephalus. The following initial temporizing surgical interventions, each used as standard treatment at participating centers, will be compared: external ventricular drainage (EVD), ventricular access device (VAD), ventricular subgaleal shunt (VSGS), and neuroendoscopic lavage (NEL). Type of surgery, perioperative data including complications and mortality, subsequent shunt surgeries, ventricular size, and neurological outcome will be recorded at 6, 12, 36, and 60 months.
An online, password-protected website will be used to collect the prospective data in a synchronized manner. As a prospective registry, data collection will be ongoing, with no prespecified endpoint. A prespecified analysis will take place after a total of 100 patients in the NEL group have been entered. Analyses will be performed for safety (6 months), shunt dependency (12, 24 months), and neurological outcome (60 months).
The design and online platform of the TROPHY registry will enable the collection of prospective data on different surgical procedures for investigation of safety, efficacy, and neurodevelopmental outcome of neonates with IVH and hydrocephalus. The long-term goal is to provide valid data on NEL that is prospective, international, and multicenter. With the comparison of different surgical treatment modalities, we hope to develop better therapy guidelines for this complex neurosurgical condition.
在脑积水患儿中，患有脑室内出血（IVH）和出血后脑积水（PH）的新生儿被认为是治疗并发症发生率最高的群体之一。尽管新生儿护理不断取得进展，但针对这种具有挑战性的疾病，仍缺乏标准化且可靠的手术管理指南。因此，有必要进一步开展研究以比较常见的手术治疗方法。神经内镜灌洗术的引入促使建立了一个国际登记处，旨在阐明标准化手术治疗的关键要素。
该登记处设计为一项针对孕41周新生儿的多中心、国际性、前瞻性数据收集研究，这些新生儿因IVH伴脑室扩张和进行性脑积水而有手术治疗指征。将比较以下几种初始的临时手术干预措施，每种措施在参与中心均作为标准治疗方法使用：脑室外引流（EVD）、脑室接入装置（VAD）、脑室帽状腱膜下分流术（VSGS）和神经内镜灌洗术（NEL）。将在6个月、12个月、36个月和60个月时记录手术类型、围手术期数据（包括并发症和死亡率）、后续分流手术情况、脑室大小和神经学转归。
将使用一个受密码保护的在线网站以同步方式收集前瞻性数据。作为一项前瞻性登记研究，数据收集将持续进行，没有预先设定的终点。在NEL组录入100例患者后将进行预先设定的分析。将针对安全性（6个月）、分流依赖情况（12个月、24个月）和神经学转归（60个月）进行分析。
TROPHY登记处的设计和在线平台将能够收集关于不同手术程序的前瞻性数据，以研究IVH和脑积水新生儿的安全性、有效性和神经发育转归。长期目标是提供有关NEL的前瞻性、国际性和多中心的有效数据。通过比较不同的手术治疗方式，我们希望为这种复杂的神经外科疾病制定更好的治疗指南。
