HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Conditions

• Hydrocephalus

Eligibility Criteria

Sex

ALL

Age

1 Day - 104 Weeks

Healthy Volunteers

Not accepted

Interventions

• Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC) — PROCEDURE
  Since the early 1990s, ETV has become the main alternative to shunting for hydrocephalus. This procedure involves placing an endoscopic camera into the ventricles of the brain and creating a hole in the floor of the third ventricle to act as an internal bypass for obstructed CSF. The cauterization of choroid plexus (CPC) involves the use of a device to burn or cauterize tissue from the choroid plexus. The choroid plexus of the brain exists in the lateral ventricles, the third ventricle, and the fourth ventricle. Its main role is the production of CSF. The success of ETV alone is poor in infants, but when combined with CPC, improved results have been observed and ETV+CPC has become a safe viable option for these children.
• Ventriculoperitoneal Shunt — DEVICE
  The most common treatment for hydrocephalus has been the insertion of a ventriculoperitoneal shunt, which has been in popular use for over 50 years. This consists of silastic tubing attached to a valve mechanism that runs subcutaneously from the head to the abdomen. It is one of the most common procedures performed by pediatric neurosurgeons.

Study Details

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.

Key Dates

First listed

Nov 26, 2019

Start date

Jul 21, 2020

Status verified

Sep 2026

Primary completion

May 30, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

165 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: ETV+CPC
  Subjects randomized to this arm will undergo an ETV+CPC procedure for treatment of Hydrocephalus
• Active Comparator: Ventriculoperitoneal Shunt
  Subjects randomized to this arm will undergo a Ventriculoperitoneal Shunt procedure for treatment of Hydrocephalus

Primary Outcome Measure

Bayley Scale of Infant Development-IV (Bayley-IV) Cognitive Scale score [ Time Frame: 12 months post randomized surgical intervention ]

Locations (18)

Find similar trials in Birmingham, AL

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