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NCT04177914 · ClinicalTrials.gov registry record · Phase 3
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
A Phase 3 study of Hydrocephalus, sponsored by University of Utah.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 176
- Enrollment target
- 20
- Study locations
NCT04177914: Recruiting Phase 3 study of Hydrocephalus, sponsored by University of Utah.
NCT04177914 is a Phase 3 study of Hydrocephalus that is actively recruiting participants, run by University of Utah. The registered enrollment target is 176 participants, above the 123-participant average among 17 other Hydrocephalus trials with a reported enrollment target (43% higher). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04177914, a Phase 3 study of Hydrocephalus, is actively recruiting participants, sponsored by University of Utah.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 176 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The primary objective is 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-IV Cognitive Scale score with a non-inferiority margin of 1.5. Scaled scores range from 1-19. Higher scores indicate better outcomes. Scores will also be obtained at 3 and 5 years of
Conditions Studied
Interventions
- PROCEDURE Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)
- DEVICE Ventriculoperitoneal Shunt
Study Locations (20)
Florida
- Wolfson Children's Hospital - Jacksonville
- Arnold Palmer Hospital for Children - Orlando
Pennsylvania
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
- The Pennsylvania State University - University Park
Alabama
- Children's of Alabama - Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
California
- Children's Hospital of Los Angeles - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
Connecticut
- Yale University - New Haven
Indiana
- Trustees of Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2020-07-21 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 3 |
What NCT04177914 shows while recruiting
NCT04177914 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, above the 123-participant average among 17 other Hydrocephalus trials with a reported enrollment target (43% higher).
The record links to 1 condition, with Hydrocephalus appearing as the primary indexed condition, and to 2 interventions - of which Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC) is the first listed.
NCT04177914 names 20 study sites across 18 states, led by Florida, Pennsylvania, Alabama.
Frequently Asked Questions
What is clinical trial NCT04177914 about?
NCT04177914 is a clinical study titled "HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants". 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 complicati...
What is the current status of trial NCT04177914?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 176 participants. The study started on 2020-07-21. Estimated completion is 2027-08-31.
What conditions does trial NCT04177914 study?
This clinical trial studies the following conditions: Hydrocephalus.
What interventions are being tested in trial NCT04177914?
The interventions under investigation include: Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC) (PROCEDURE), Ventriculoperitoneal Shunt (DEVICE).
Who is sponsoring clinical trial NCT04177914?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04177914 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hydrocephalus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04177914's enrollment target sits among peer trials
176 3rd of 17 higher than 15 of 17 other Hydrocephalus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hydrocephalus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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