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Comparing Treatments for Hydrocephalus in Infants

This study is comparing two ways to treat hydrocephalus (fluid buildup in the brain) in infants: Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC) and Ventriculoperitoneal Shunt. ETV+CPC is a procedure where a small hole is made in the brain to help fluid drain, while a shunt is a tube placed to drain fluid to the abdomen. The study wants to see if one treatment leads to better intellectual development in babies. You might be able to join if your baby is between 1 day and 104 weeks old, is at least 37 weeks post-menstrual age, and has symptomatic hydrocephalus with specific findings on an MRI scan. The main goal is to compare intellectual outcomes using the Bayley Scale of Infant Development-IV at 12 months after surgery. The study's current status is unclear.

Study design
This is an interventional study comparing two treatments for hydrocephalus in infants. It plans to enroll 176 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 months after their surgical intervention to assess cognitive development.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04177914

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Recruiting
PHASE3Ages 1+InterventionalTreatment
University of Utah
~176 participants
Updated 2025-06-11 on ClinicalTrials.gov
What's tested:Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)Ventriculoperitoneal Shunt

At a glance

Recruiting sites
16 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bayley Scale of Infant Development-IV (Bayley-IV) Cognitive Scale score
Measured over 12 months post randomized surgical intervention

Conditions

Hydrocephalus

Explore related trials

Hydrocephalus

Where it's being run

21 sites across 19 states
Florida2
Pennsylvania2
Alabama1
Arizona1
California1
Colorado1
Connecticut1
Indiana1

Study leadership

  • John Kestle, MD · STUDY_CHAIR · University of Utah
  • Abhaya Kulkarni, MD · PRINCIPAL_INVESTIGATOR · University of Toronto
  • David Limbrick, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
  • Richard Holubkov, PhD · PRINCIPAL_INVESTIGATOR · University of Utah

Who to contact

Nichol Nunn
[email protected]
801-458-6593
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Head circumference \>98th percentile for corrected age with either bulging fontanelle or splayed sutures
Upgaze paresis/palsy (sundowning)
CSF leak
Papilledema
Tense pseudomeningocele or tense fluid along a track
Vomiting or irritability, with no other attributable cause
Bradycardias or apneas, with no other attributable cause
Intracranial pressure (ICP) monitoring showing persistent elevation of pressure with or without plateau waves

Exclusion

Moderate to severe prepontine adhesions on steady state free precession (SSFP) or T2 weighted fast (turbo) spin echo (FSE/TSE) MRI, which includes the following sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE), CUBE, SPACE, VISTA, IsoFSE, and 3D MVOX
Closure of one or both foramina of Monro
Thick floor of third ventricle (≥ 3mm)
Narrow third ventricle (\<5mm)
Presence of scalp, bone, or ventricular lesions that make placement of an anterior shunt impracticable; OR 3. Underlying condition with a high chance of mortality within 12 months; OR 4. Hydrocephalus with loculated CSF compartments; OR 5. Peritoneal cavity not suitable for distal shunt placement; OR 6. Active CSF infection; OR 7. Hydranencephaly; OR 8. Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.

What this trial measures

  • Bayley Scale of Infant Development-IV (Bayley-IV) Cognitive Scale score12 months post randomized surgical intervention

    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 age.