Clinical Trial

Randomized Controlled Trial of Shunt vs ETV/CPC for PIH in Ugandan Infants

Active, Not Recruiting Phase 3
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Record status
This record was last updated May 18, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
Two treatment options exist for infant patients with hydrocephalus. Most patients are treated with a surgical procedure in which a shunt is inserted into the brain and abdomen. In recent years, however, another treatment has developed called Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC).This research study is being done to measure the results of these procedures in children less than six months of age who have hydrocephalus as the result of a brain infection, called post-infectious hydrocephalus, or PIH. This study will evaluate patients in more detail to measure brain growth and development.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2013-09-03; most recent amendment 2026-05-14.
Status change: Recruiting → Active, Not Recruiting 2017-03-15
Trial Details
NCT Number NCT01936272
Lead Sponsor Boston Children's Hospital
Collaborators: Penn State University, The Hospital for Sick Children, CURE Children's Hospital, Uganda
Conditions Hydrocephalus
Enrollment 100 participants
Start Date 2013-05-27
Primary Completion 2026-06 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-05-18