Skip to main content
Update Location

My Location

Update your location to show providers, locations, and services closest to you.

Enter a zip code
Or
Select a campus/region
(904) 244-0411

Endoscopic versus Shunt Treatment of Hydrocephalus in Infants

  • Status
    Accepting Candidates
  • Age
    N/A
  • Sexes
    All
  • Healthy Volunteers
I'm interested
Share this study
Facebook
Twitter
LinkedIn

Description

Hydrocephalus largely affects babies under a year old. It has traditionally been treated by shunt insertion. A newer endoscopic procedure offers hope of a treatment that may reduce complications in a child's life, but it is unclear if the procedure results in similar intellectual outcome as shunt. We propose a randomized trial to compare intellectual outcome and brain structural integrity between these 2 treatments, to help families make the best treatment decision for their baby.

Details

Protocol number CED000000292

Eligibility

Inclusion Criteria (ALL of the following must be present):
 
1. Corrected age <104 weeks and 0 days,
AND
2. Child is _ 37 weeks post-menstrual age (PMA),
 
AND
 
3. Child must have symptomatic hydrocephalus, defined as:
 
_ Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) >0.45, which
Approximates \moderate ventriculomegaly"2), and at least one of the following:
 
- Head circumference >98th percentile for corrected age with bulging fontanelle or splayed sutures
- Upgaze paresis/palsy (sundowning)
- CSF leak
 Papilledema
- Tense pseudomeningocele or tense uid 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 sagittal constructive interference steady state (CISS) fast imaging employing steady state acquisition (FIESTA)
MRI
_ 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.


Lead researchers

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.