Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04177914 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Study acronym: ESTHI
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase changed: Phase 3 → not applicable Enrollment closed, study ongoing · Enrollment target: estimated 176 to confirmed 165 · Eligibility criteria expanded, about 25 words · 3 more Show 6 more changesShow less
    • Enrollment closed, study ongoing
    • Enrollment target: estimated 176 to confirmed 165
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised at 21 of 21 sites
    • Collaborators: 21 to 20
  2. Study sites: 19 to 21 Collaborators: 20 to 21v13 Show 1 more changeShow less
    • Collaborators: 20 to 21

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jan 30, 2025 to May 30, 2027 Study sites: 17 to 19 · Completion date: Sep 30, 2027 to Aug 31, 2027 · Collaborators: 19 to 20v12 Show 3 more changesShow less
    • Study sites: 17 to 19
    • Completion date: Sep 30, 2027 to Aug 31, 2027
    • Collaborators: 19 to 20

    See this version in full on ClinicalTrials.gov ↗

  4. 3 versions Re-verified since Nov 16, 2023, no change to tracked fieldsv9-v11
  5. Primary completion date: Jan 30, 2024 to Jan 30, 2025 Completion date: Sep 30, 2026 to Sep 30, 2027v8 Show 1 more changeShow less
    • Completion date: Sep 30, 2026 to Sep 30, 2027
Show 6 earlier versionsHide 6 earlier versions
  1. Re-verified, no change to tracked fieldsv7
  2. Phase: Not applicable to Phase 3 Study sites: 16 to 17 · Start date: Aug 6, 2020 to Jul 21, 2020v6 Show 2 more changesShow less
    • Study sites: 16 to 17
    • Start date: Aug 6, 2020 to Jul 21, 2020
  3. Eligibility criteria expanded, about 20 words Site details revised at 4 of 16 sitesv5 Show 1 more changeShow less
    • Site details revised at 4 of 16 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Eligibility criteria shortened, about 27 words Site details revised at 11 of 16 sites · Collaborators revised (19)v4 Show 2 more changesShow less
    • Site details revised at 11 of 16 sites
    • Collaborators revised (19)

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 16 · Start date changed from estimate of Jul 30, 2020 to Aug 6, 2020 · Collaborators: 16 to 19v3 Show 3 more changesShow less
    • Study sites: 0 to 16
    • Start date changed from estimate of Jul 30, 2020 to Aug 6, 2020
    • Collaborators: 16 to 19

    See this version in full on ClinicalTrials.gov ↗

  6. Primary completion date: Jan 31, 2025 to Jan 30, 2024 Start date: Jan 11, 2020 to Jul 30, 2020 · Completion date: Jan 31, 2027 to Sep 30, 2026 · Eligibility criteria expanded, about 3 wordsv2 Show 3 more changesShow less
    • Start date: Jan 11, 2020 to Jul 30, 2020
    • Completion date: Jan 31, 2027 to Sep 30, 2026
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  1. 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.
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.
Trial Details
NCT Number NCT04177914
Lead Sponsor University of Utah
Collaborators: University of Alabama at Birmingham, University of British Columbia, University of Pittsburgh, The Hospital for Sick Children, Seattle Children's Hospital, Vanderbilt University Medical Center, Washington University School of Medicine, Nationwide Children's Hospital, Johns Hopkins University, University of Calgary, University of Colorado, Denver, Children's Hospital Los Angeles, National Institutes of Health (NIH), Hydrocephalus Association, Penn State University, National Institute of Neurological Disorders and Stroke (NINDS), Baylor College of Medicine, Orlando Health, Inc., Virginia Commonwealth University, Trustees of Indiana University
Conditions Hydrocephalus
Enrollment 165 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov