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Comparing two treatments for hydrocephalus in infants

Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Phase 3 Interventional University of Utah · NCT04177914

This study is testing two different treatments for hydrocephalus in infants to see which one helps their brain development and cognitive skills better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment176 (estimated)
Ages1 Day to 104 Weeks
SexAll
SponsorUniversity of Utah Academic / other
Locations21 sites (Birmingham, Alabama and 20 other locations)
Trial IDNCT04177914 on ClinicalTrials.gov

What this trial studies

This clinical trial compares two treatment methods for hydrocephalus in infants: the traditional ventriculoperitoneal shunt and a newer endoscopic procedure known as endoscopic third ventriculostomy with choroid plexus cauterization (ETV+CPC). Conducted across multiple leading pediatric neurosurgical centers, the study aims to assess the cognitive outcomes and brain structural integrity associated with each treatment. By utilizing advanced imaging techniques, the trial seeks to provide families with critical information to make informed decisions regarding their child's treatment. The primary focus is on optimizing cognitive outcomes, which is a major concern for families dealing with this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are infants under 104 weeks of corrected age who have symptomatic hydrocephalus.

Not a fit: Patients with a prior history of shunt insertion or endoscopic third ventriculostomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer, shunt-free treatment option for infants with hydrocephalus, potentially leading to better long-term cognitive outcomes.

How similar studies have performed: Other studies have explored similar treatment comparisons, but this trial aims to provide more definitive insights into cognitive outcomes, making it a significant addition to existing research.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Corrected age \<104 weeks and 0 days,

   AND
2. Child is ≥ 37 weeks post menstrual age,

   AND
3. Child must have symptomatic hydrocephalus, defined as:

   Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) \>0.45, which approximates "moderate ventriculomegaly"), and at least one of the following:
   * 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

   AND
4. No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)

Exclusion Criteria:

1. Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR
2. Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shunt defined as:

   * 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.

Where this trial is running

Birmingham, Alabama and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HydrocephalusInfantsVentriculoperitoneal ShuntETV+CPCendoscopic third ventriculostomychoroid plexus cauterization
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.