Endoscopic versus Shunt Treatment of Hydrocephalus in Infants (ESTHI)
Endoscopic versus Shunt Treatment of Hydrocephalus in Infants (ESTHI)
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Clinical Trial Information
Trial Contact: Guerrero, Richard; Roppo, Emily
Trial Phone: 3218411361 ; 321.842.7567
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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
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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.
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Key Eligibility
All infants <104 weeks and 0 days corrected age requiring a first-time permanent procedure for the treatment of hydrocephalus
