HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants (NCT04177914) | Clinical Trial Compass
RecruitingPhase 3
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
United States176 participantsStarted 2020-07-21
Plain-language 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.
Who can participate
Age range1 Day – 104 Weeks
SexALL
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Inclusion criteria
✓. Corrected age \<104 weeks and 0 days,
✓. Child is ≥ 37 weeks post menstrual age,
✓. Child must have symptomatic hydrocephalus, defined as:
✓. 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:
✕. 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
✕
What they're measuring
1
Bayley Scale of Infant Development-IV (Bayley-IV) Cognitive Scale score
Timeframe: 12 months post randomized surgical intervention
✕. Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.