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HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

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1 day to 104 weeks old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Corrected age \<104 weeks and 0 days, AND
• Child is ≥ 37 weeks post menstrual age, AND
• Child must have symptomatic hydrocephalus, defined as: Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) \>0.45, which approximates "moderate ventriculomegaly"), and at least one of the following: * Head circumference \>98th percentile for corrected age with either bulging fontanelle or splayed sutures * Upgaze paresis/palsy (sundowning) * CSF leak * Papilledema * Tense pseudomeningocele or tense fluid along a track * Vomiting or irritability, with no other attributable cause * Bradycardias or apneas, with no other attributable cause * Intracranial pressure (ICP) monitoring showing persistent elevation of pressure with or without plateau waves AND
• No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)
Exclusion Criteria:

• Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR
• Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shunt defined as: * Moderate to severe prepontine adhesions on steady state free precession (SSFP) or T2 weighted fast (turbo) spin echo (FSE/TSE) MRI, which includes the following sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE), CUBE, SPACE, VISTA, IsoFSE, and 3D MVOX * Closure of one or both foramina of Monro * Thick floor of third ventricle (≥ 3mm) * Narrow third ventricle (\<5mm) * Presence of scalp, bone, or ventricular lesions that make placement of an anterior shunt impracticable; OR
• Underlying condition with a high chance of mortality within 12 months; OR
• Hydrocephalus with loculated CSF compartments; OR
• Peritoneal cavity not suitable for distal shunt placement; OR
• Active CSF infection; OR
• Hydranencephaly; OR
• Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.

PROCEDURE: Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC), DEVICE: Ventriculoperitoneal Shunt

Hydrocephalus

Hydrocephalus, Infants, Ventriculoperitoneal Shunt, ETV+CPC, endoscopic third ventriculostomy, choroid plexus cauterization

Nichol Nunn - nichol.nunn@hsc.utah.edu
PHASE3
NCT04177914

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