Hydrocephalus - Endoscopic versus Shunt Treatment of Hydrocephalus in Infants (ESTHI)
What is the goal of this study?
Hydrocephalus is a neurological condition that primarily affects infants under one year of age. Shunt placement and Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC) are commonly used treatments for hydrocephalus. It is unknown if one of these procedures is better than the other.
This multi-centered randomized controlled trial aims to understand the effects of shunt vs. ETV+CPC on brain function. Additionally, researchers will compare measures of treatment performance to assess long-term outcomes of both procedures.
Who can join the study?
This study may be a good fit for:
- Eligible patients are 24 months or younger (corrected age) and undergoing surgery for treatment of hydrocephalus
- Patients must be able to have either surgical procedure (Shunt or Endoscopic Third Ventriculostomy + Choroid Plexus Cauterization).
Your neurosurgeon will determine whether you meet eligibility criteria and will discuss the ESTHI Study with you if they believe it would be a good fit for your child.
What will happen if my child takes part in this study?
If you choose to participate:
- The research team will share your child's health information with a panel of surgeons who will confirm that both procedures are good options for your child.
- Research staff will review the panel's decision with you and ask from your consent to randomize.
- If you consent to randomization, your child will undergo shunt placement or ETV + CPC. Your child's procedure will be determined by random selection in the operating room. Your neurosurgeon will not be able to tell you which operation will take place ahead of the procedure. Researchers will collect a small sample of cerebrospinal fluid (CSF) during your child's operation.
- You will be invited to attend follow-up appointments at 3- and 12-months post-operation and when your child is 3 and 5 years of age. Follow-up appointments include parent surveys, brain imaging, and neurodevelopmental assessments.
- During any subsequent hydrocephalus operations, the research team will collect additional samples of CSF for analysis.
Who can I contact for more information?
Study contact: Hope Willis
Learn more about this study on the Hydrocephalus Clinical Research Network