Clinical Research Details

Clinical Research

Endoscopic versus Shunt Treatment of Hydrocephalus in Infants

Study 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.

Inclusion/Exclusion Criteria

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.

Open Enrollment

Contact Name: Asmaa Hatem
Contact Phone: (216) 575-4070
Contact Email: asmaa.hatem@jax.ufl.edu

Investigators


Philipp R. Aldana, M.D., FAANS, FAAP
Neurosurgery