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临床试验/NCT07733778
NCT07733778尚未招募不适用

Role of Neuro-endoscopic Lavage in the Management of Neonatal Intra-ventricular Hemorrhage

Assiut University0 个研究点目标入组 30 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Rate of PHVD and permanent VP shunt insertion within the follow-up period after neuro-endoscopic lavage

研究概览

简要总结

Neonatal intraventricular hemorrhage (IVH) is a major cause of morbidity and mortality in premature infants and is frequently associated with post-hemorrhagic ventricular dilatation (PHVD) and hydrocephalus. Neuroendoscopic lavage (NEL) is a minimally invasive technique that allows removal of intraventricular blood clots and inflammatory debris, potentially reducing cerebrospinal fluid pathway obstruction and the need for permanent cerebrospinal fluid diversion. This prospective interventional study aims to evaluate the safety, feasibility, and clinical outcomes of neuroendoscopic lavage in neonates with IVH-related hydrocephalus. Patients will be assessed clinically and radiologically before and after the procedure, with follow-up focusing on ventricular size, shunt dependency, procedure-related complications, and neurological outcomes.

详细描述

Neonatal intra-ventricular hemorrhage (IVH) is one of the most common and serious neurological complications affecting premature infants, particularly those born before 32 weeks of gestation and those with very low birth weight. Despite advances in neonatal intensive care, IVH remains a significant cause of mortality and long-term neurodevelopmental disability worldwide (1,2).

The pathogenesis of IVH is closely related to the fragility of the germinal matrix vasculature and the immaturity of cerebral auto-regulation in premature neonates. Fluctuations in cerebral blood flow may result in rupture of these fragile vessels, leading to hemorrhage that can extend into the ventricular system (2,3).

The severity of IVH is commonly classified according to the Papile grading system into four grades. Grades III and IV are associated with the highest rates of morbidity and mortality and carry a significant risk of developing post-hemorrhagic ventricular dilatation (PHVD) and post-hemorrhagic hydrocephalus (PHH) (1,4).

Post-hemorrhagic ventricular dilatation develops as a result of obstruction of cerebrospinal fluid (CSF) pathways by intra-ventricular blood clots and inflammatory debris. Furthermore, blood degradation products trigger inflammatory reactions that impair CSF circulation and absorption, leading to progressive ventricular enlargement and secondary brain injury (3,5).

Several treatment modalities have been proposed for the management of PHVD and PHH, including serial lumbar punctures, ventricular reservoir insertion, ventriculo-subgaleal shunting, external ventricular drainage (EVD), and ventriculo-peritoneal (VP) shunt placement. However, these methods primarily provide CSF diversion without directly removing intra-ventricular blood products that contribute to ongoing inflammation and ventricular dilatation (5,6).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates aged 28 days or less at the time of presentation.
  • Neonates diagnosed with severe IVH with ventricular dilatation (Grade III or IV on Papile classification).
  • Written informed consent obtained from parents or legal guardians -

排除标准

  • Grade I or Grade II intra-ventricular hemorrhage according to the Papile classification.
  • Major congenital brain malformations, like Dandy-Walker malformation and Holoprosencephaly or severe congenital anomalies incompatible with life.
  • Neonates with active central nervous system infection (meningitis or ventriculitis).
  • Severe coagulopathy not correctable before surgery.
  • Refusal of parental or legal guardian consent

研究组 & 干预措施

Neuro-endoscopic lavage in the management of neonatal intra-ventricular hemorrhage

Other

Single arm

干预措施: Neuro-endoscopy (Procedure)

结局指标

主要结局

Rate of PHVD and permanent VP shunt insertion within the follow-up period after neuro-endoscopic lavage

时间窗: 3 years

To evaluate the rate of post hemorrhagic ventricular dilatation and the need for permanent VP shunt after neuroendoscopic lavage for neonatal intra-ventricular hemorrhage

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Aboelmagd Ahmed

Assistant lecturer

Assiut University

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