Neurocognitive Outcomes and Changes in Brain and Cerebral Spinal Fluid (CSF) Volume After Treatment of Post-Infectious Hydrocephalus (PIH) in Ugandan Infants by Shunting Versus ETV/CPC
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of Age-normed Bayley Scales of Infant Development (BSID)-III scores
研究概览
简要总结
Two treatment options exist for infant patients with hydrocephalus. Most patients are treated with a surgical procedure in which a shunt is inserted into the brain and abdomen. In recent years, however, another treatment has developed called Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC).This research study is being done to measure the results of these procedures in children less than six months of age who have hydrocephalus as the result of a brain infection, called post-infectious hydrocephalus, or PIH. This study will evaluate patients in more detail to measure brain growth and development.
详细描述
World over, infants with hydrocephalus are mainly treated using a shunt, which is a device made of soft plastic tubing that moves extra fluid from the brain to the abdomen. Surgery is required to insert a shunt into the brain and the abdomen. In recent years, we have developed another treatment called Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC). This research study is being done to measure the results of these procedures in children less than six months of age who have hydrocephalus as the result of a brain infection, called post-infectious hydrocephalus, or PIH. This is the most common cause of hydrocephalus in Ugandan babies. This study will evaluate patients in more detail to measure brain growth and development. Children in the study will have special testing to measure developmental progress as well as special imaging to evaluate the progress of their brain growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 1 Day 至 180 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants less than 180 days (six months) old
- •Symptomatic hydrocephalus
- •Post-infectious Hydrocephalus based on clinical and CT parameters2
- •Must be from the following Ugandan districts: Bugiri, Busia, Iganga, Jinja, Kampala, Kamuli, Kapchorwa, Katakwi, Kumi, Mayuge, Mbale, Mukono, Pallisa, Sironko, Soroti, and Tororo
排除标准
- •Any patient with a scalp erosion or infection that would exclude the patient from shunt implantation
- •Any patient with ventricular loculations that would normally indicate the use of ventriculoscopy as an adjunct to shunt placement
- •Any patient with absence of any visible cortical mantle on the CT
- •Patients must be appropriate candidates for either surgical procedure - shunt placement alone or ETV/CPC
研究组 & 干预措施
Chhabra Shunt Placement
The shunting arm will comprise a standard frontal approach ventriculoperitoneal shunt using a silastic Chhabra system.
干预措施: Chhabra Shunt Placement (Device)
ETV/CPC
The Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) arm will comprise a standard frontal approach with flexible endoscopy.
干预措施: ETV/CPC (Procedure)
结局指标
主要结局
Change of Age-normed Bayley Scales of Infant Development (BSID)-III scores
时间窗: 12 months and 24 months post treatment
Neurocognition will be measured using the BSID-III Cognitive Scale. Change will be assessed at 24 months post treatment from baseline score (12 months post treatment).
次要结局
- Brain Volume(12 months, 24 months, 5 years, and 7-10 years post treatment)
- CSF Volume(12 months, 24 months, 5 years, and 7-10 years post treatment)
- Vineland Adaptive Behavior Scales(5 years and 7-10 years post treatment)
研究者
Benjamin C. Warf
Professor of Neurosurgery, Hydrocephalus and Spina Bifida Chair
Boston Children's Hospital