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

StatusActive, Not Recruiting
PhasePhase 3
Started
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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.

Record History

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  1. Minor Primary completion date: Dec 2025 to Jun 2026
    • Study completion date: Dec 2025 to Oct 2026
    v9
  2. Notable Phase: Not applicable to Phase 3v8
  3. Notable Phase: Phase 3 to Not applicablev7
  4. Notable Phase: Not applicable to Phase 3
    • Start date: Apr 2013 to May 27, 2013
    v6
  5. Notable Primary completion date: Sep 2020 to Dec 2025
    • Study completion date: Mar 2021 to Dec 2025
    • Secondary endpoints: details revised at 3 of 3 entries
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Notable Phase: Phase 3 to Not applicablev4
  2. Notable Primary completion date: Nov 2017 to Sep 2020
    • Primary endpoint revised
    • Study completion date: Mar 2018 to Mar 2021
    • Secondary endpoints: 2 to 3
    v3
  3. Notable Primary completion date: Jun 2015 to Nov 2017v2 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 2015 to Mar 2018
    • Interventions: ETV/CPC (Procedure), Surgical placement of Chhabra Shunt (Device) to Chhabra Shunt Placement (Device), ETV/CPC (Procedure)
    • Study description expanded, about 147 words
    • Site details revised
    • Study title shortened, about 8 words
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)
Hydrocephalus
Related terms Hydrocephalus
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov