HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants (NCT04177914) | Clinical Trial Compass
RecruitingPhase 3
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
United States, Canada176 participantsStarted 2020-07-21
Plain-language 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.
Who can participate
Age range
1 Day – 104 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Corrected age \<104 weeks and 0 days,
. Child is ≥ 37 weeks post menstrual age,
. Child must have symptomatic hydrocephalus, defined as:
. No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)
Exclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bayley Scale of Infant Development-IV (Bayley-IV) Cognitive Scale score
Timeframe: 12 months post randomized surgical intervention
. 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.