Primary Outcome Measures:
- Health Status Outcome as measured by the Health Utilities Index - 2 [ Time Frame: At 5 years of age ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Death [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
- Neurodevelopment as measured by the Denver Developmental Screening Test [ Time Frame: Up to 3 years of Age ] [ Designated as safety issue: Yes ]
- Health status outcome using the Hydrocephalus Outcome Questionnaire [ Time Frame: At 5 years of Age ] [ Designated as safety issue: Yes ]
- In-depth Evaluation of Neurodevelopment, Functioning and Intelligence, as mesured by the Weschler Intelligence Scale for Children or Weschler Preschool and Primary Scale of Intelligence [ Time Frame: At 5 years of Age ] [ Designated as safety issue: No ]
- Number of Subsequent Hydrocephalus-Related Operations [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
- Surgical Morbidity [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
- Incidence of failure of initial intervention [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
- Hospitalization Time [ Time Frame: 5 years post-operation ] [ Designated as safety issue: No ]
- Need for repeat radiological scans [ Time Frame: Duration of the Study ] [ Designated as safety issue: No ]
- Complications such as CNS infection, focal neurological deficit, significant hemorrhage, seizures requiring medication [ Time Frame: Duration of the Study ] [ Designated as safety issue: Yes ]
- Ventricular size and the existence of flow void (ETV group)assessed through radiological evaluation [ Time Frame: 3 years of age ] [ Designated as safety issue: Yes ]
TVH is a relatively uncommon condition in infants, in which CSF accumulates in the brain's ventricles due to a blockage in outflow at the level of cerebral aqueduct. This can cause increased intracranial pressure, with adverse effect on brain development. The causes of this include congenital aqueductal stensois or acquired aqueductal stenosis from previous brain hemorrhage or infection.
TVH is currently treated through one of the following two approaches:
- Extra-cranial CSF diversion through ventricular shunts. Extra-cranial shunting has been the standard approach over the past few decades, since functional shunts were first developed and inserted successfully.
- Intra-cranial internal CSF diversion using endoscopic techniques. The principles of internal diversion were clear from the time neurosurgeons first understood the nature of hydrocephalus. However, internal diversion was never really practical or successful on a large scale until the more recent development of neuroendoscopy. There is currently a revived interest in diversionary hydrocephalus treatment through neuroendoscopic surgical techniques, with the primary focus on endoscopic third ventriculostomy (ETV).
Purpose
