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Compares treatment options for Hydrocephalus
Official title HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
ClinicalTrials.gov ID: NCT04177914
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 104
You may be able to join if
- Corrected age \<104 weeks and 0 days, AND
- Child is ≥ 37 weeks post menstrual age, AND
- Child must have symptomatic hydrocephalus, defined as: Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) \>0.45, which approximates...
- Head circumference \>98th percentile for corrected age with either bulging fontanelle or splayed sutures
- Upgaze paresis/palsy (sundowning)
You likely can't join if
- Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR
- 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...
- Closure of one or both foramina of Monro
- Thick floor of third ventricle (≥ 3mm)
- Narrow third ventricle (\<5mm)
See the full eligibility criteria
- Corrected age \<104 weeks and 0 days, AND
- Child is ≥ 37 weeks post menstrual age, AND
- 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
- No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)
- Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR
- 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...
- 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
- Underlying condition with a high chance of mortality within 12 months; OR
- Hydrocephalus with loculated CSF compartments; OR
- Peritoneal cavity not suitable for distal shunt placement; OR
- Active CSF infection; OR
- Hydranencephaly; OR
- Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- University Park, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Richmond, Virginia, United States
- Seattle, Washington, United States
- Calgary, Alberta, Canada
- Vancouver, British Columbia, Canada
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 day to 104 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Los Angeles, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Jacksonville, Florida, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.