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Endoscopic versus Shunt Treatment of Hydrocephalus in Infants (ESTHI)

Endoscopic versus Shunt Treatment of Hydrocephalus in Infants (ESTHI)

  • Clinical Trial Information

    Trial Contact: Parrimon, Yazandra; Teneyck, Tyler

    Trial Phone: 321.841.1361 ; 321.841.1986

  • IRB No: S20.092.06

    Protocol Abbrev: ESTHI

    Principal Investigator: Samer K Elbabaa, MD

    Age Group: Pediatric

    Secondary Protocol No: HCRN Protocol 012 Version 1.01

    Therapies Involved: Surgery

    ClinicalTrials.gov ID: NCT04177914

  • Objective

    To determine, in infants <104 weeks corrected age, with hydrocephalus requiring treatment at tertiary care pediatric neurosurgery centers in North America, if treatment with ETV+CPC compared to shunt results in non-inferior cognitive outcome at 12 months from surgery, as measured by Bayley-4 Cognitive Scale Score with a non-inferiority margin of 1.5.

  • Key Eligibility

    All infants <104 weeks and 0 days corrected age requiring a first-time permanent procedure for the treatment of hydrocephalus