HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants (ESTHI)
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- STATUS
- Recruiting
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- End date
- Sep 30, 2026
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- participants needed
- 176
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- sponsor
- University of Utah
Summary
Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complications over a child's life, but it is not clear if the endoscopic procedure results in similar intellectual outcome as shunt. Therefore, the investigators propose a randomized trial to compare intellectual outcome and brain structural integrity between these two treatments, to help families make the best treatment decision for their baby.
Description
The ESTHI Trial is a multi-center randomized controlled trial (RCT) comparing endoscopic third ventriculostomy with choroid plexus cauterization (ETV+CPC) and shunt in infants with hydrocephalus. The study will leverage the infrastructure of the Hydrocephalus Clinical Research Network (HCRN), a committed group of 14 leading North American pediatric neurosurgical centers with a long track-record of successful collaborative clinical research and RCTs in hydrocephalus. Optimal cognitive outcome is the primary concern of families and will, therefore, be the primary outcome. Assessment of dMRI, a validated, non-invasive method of measuring white matter microstructural integrity and structural connectivity in the developing brain, will provide further insight into the developmental consequences of these two treatments. The results of the RCT will help families determine the optimal treatment of hydrocephalus for their child.
Details
| Condition | Hydrocephalus |
|---|---|
| Treatment | Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC), Ventriculoperitoneal Shunt, Ventriculoperitoneal Shunt |
| Clinical Study Identifier | NCT04177914 |
| Sponsor | University of Utah |
| Last Modified on | 23 March 2022 |
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