A Study Comparing Two Treatments for Infants With Hydrocephalus
|ClinicalTrials.gov Identifier: NCT00652470|
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : September 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hydrocephalus||Procedure: Endoscopic Third Ventriculostomy Procedure: CSF Shunt Insertion||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||182 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||International Infant Hydrocephalus Study: A Multicentre, Prospective Study|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||May 1, 2018|
|Actual Study Completion Date :||May 1, 2018|
|Active Comparator: ETV||
Procedure: Endoscopic Third Ventriculostomy
A standard frontal burr hole will be made and an endoscopic camera used to visualize the floor of the third ventricle. A ventriculostomy will be created in the floor of the third using the surgeon's own preferred method of perforation.
|Active Comparator: CSF Shunt||
Procedure: CSF Shunt Insertion
The procedure involves creating a burr hole in the frontal or occipital regions and cannulating the ventricle with a silastic catheter. This is then attached to a valve mechanism and distal silastic tubing which runs subcutaneously in the peritoneal cavity.
- Health Status Outcome as measured by the Health Utilities Index - 2 [ Time Frame: At 5 years of age ]
- Death [ Time Frame: Duration of the Study ]
- Neurodevelopment as measured by the Denver Developmental Screening Test [ Time Frame: Up to 3 years of Age ]
- Health status outcome using the Hydrocephalus Outcome Questionnaire [ Time Frame: At 5 years of Age ]
- 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 ]
- Number of Subsequent Hydrocephalus-Related Operations [ Time Frame: Duration of the Study ]
- Surgical Morbidity [ Time Frame: Duration of the Study ]
- Incidence of failure of initial intervention [ Time Frame: Duration of the Study ]
- Hospitalization Time [ Time Frame: 5 years post-operation ]
- Need for repeat radiological scans [ Time Frame: Duration of the Study ]
- Complications such as CNS infection, focal neurological deficit, significant hemorrhage, seizures requiring medication [ Time Frame: Duration of the Study ]
- Ventricular size and the existence of flow void (ETV group)assessed through radiological evaluation [ Time Frame: 3 years of age ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652470
|Principal Investigator:||Abhaya Kulkarni, MD||The Hospital for Sick Children, Toronto Canada|
|Principal Investigator:||Shlomi Constantini, MD||Dana Children's Hospital, Tel Aviv Medical Center|
|Principal Investigator:||Spyros Sgouros, MD||Birmingham Children’s Hospital|