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临床试验/NCT01480349
NCT01480349已完成不适用

Shunt Outcomes of Post-Hemorrhagic Hydrocephalus: A Network Pilot Study

University of Utah7 个研究点 分布在 2 个国家目标入组 146 人开始时间: 2011年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
7
主要终点
Specific Aim I: Proportion of temporization

研究概览

简要总结

This multicenter, prospective pilot study will compare the effectiveness of two established procedures used in the treatment of post-hemorrhagic hydrocephalus in very low birth weight infants, specifically ventricular reservoirs and subgaleal shunts. The study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus.

详细描述

Intraventricular hemorrhage and post-hemorrhagic hydrocephalus remain a leading cause of mortality and long-term morbidity in premature infants. The two most common temporary cerebrospinal fluid (CSF) diversion procedures are the ventriculosubgaleal shunt (SGS) and an implanted ventricular reservoir (RES) for intermittent CSF removal. These methods are physiologically very different and their comparative effectiveness in treating hydrocephalus and possibly reducing the need for an eventual permanent CSF shunt is currently not known. The goal of this pilot study is to obtain information critical for planning and executing a future randomized trial comparing SGS and RES. Specifically, this pilot study will establish inclusion criteria, define the primary outcome, and standardize the interventions in preparation for initiating a comparative trial between the SGS and RES procedures. In addition, the importance of examining the neurodevelopmental outcomes for these patients has been recognized within the neurosurgical and neuropsychological settings. Therefore, the scope of this study has been extended to include an examination of the neurodevelopmental outcomes at 18 to 22 months and at 36 to 42 months in patients who undergo BSID-III testing at their clinical centers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 180 Days(Child)
性别
All
接受健康志愿者

入选标准

  • premature neonates with birth weights less than 1500 grams
  • Grade III or IV intraventricular hemorrhage
  • Fronto-occipital horn ratio greater than or equal to 0.50

排除标准

  • Less than 72 hour life expectancy from other medical problems

结局指标

主要结局

Specific Aim I: Proportion of temporization

时间窗: 5 years

The proportion of all infants entering the study who meet the criteria for surgical temporization.

Specific Aim 2: Conversion proportion

时间窗: 5 years

The proportion of all infants with SGS or RES who met criteria for conversion to permanent shunt.

Specific Aim 3: Surgery Checklist Scores

时间窗: 5 years

Surgery checklist scores of individual surgeon performance in standardized procedures.

次要结局

  • Protocol adherence(5 years)
  • CSF Infection(5 years)
  • Neurodevelopmental Outcomes(7 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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