Randomized Controlled Trial of Shunt vs ETV/CPC for PIH in Ugandan Infants

Boston Children's Hospital

Status and phase: Active, not recruiting; Phase 3

Conditions: Hydrocephalus

Treatments: Device: Chhabra Shunt Placement; Procedure: ETV/CPC

Study type: Interventional

Funder types: Other

Identifiers

NCT01936272

P00002785

Details and patient eligibility

About

Two treatment options exist for infant patients with hydrocephalus. Most patients are treated with a surgical procedure in which a shunt is inserted into the brain and abdomen. In recent years, however, another treatment has developed called Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC).This research study is being done to measure the results of these procedures in children less than six months of age who have hydrocephalus as the result of a brain infection, called post-infectious hydrocephalus, or PIH. This study will evaluate patients in more detail to measure brain growth and development.

Full description

World over, infants with hydrocephalus are mainly treated using a shunt, which is a device made of soft plastic tubing that moves extra fluid from the brain to the abdomen. Surgery is required to insert a shunt into the brain and the abdomen. In recent years, we have developed another treatment called Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC). This research study is being done to measure the results of these procedures in children less than six months of age who have hydrocephalus as the result of a brain infection, called post-infectious hydrocephalus, or PIH. This is the most common cause of hydrocephalus in Ugandan babies. This study will evaluate patients in more detail to measure brain growth and development. Children in the study will have special testing to measure developmental progress as well as special imaging to evaluate the progress of their brain growth.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 180 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants less than 180 days (six months) old
• Symptomatic hydrocephalus
• Post-infectious Hydrocephalus based on clinical and CT parameters2
• Must be from the following Ugandan districts: Bugiri, Busia, Iganga, Jinja, Kampala, Kamuli, Kapchorwa, Katakwi, Kumi, Mayuge, Mbale, Mukono, Pallisa, Sironko, Soroti, and Tororo

Exclusion criteria

• Any patient with a scalp erosion or infection that would exclude the patient from shunt implantation
• Any patient with ventricular loculations that would normally indicate the use of ventriculoscopy as an adjunct to shunt placement
• Any patient with absence of any visible cortical mantle on the CT
• Patients must be appropriate candidates for either surgical procedure - shunt placement alone or ETV/CPC

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Chhabra Shunt Placement

Active Comparator group

Description:

The shunting arm will comprise a standard frontal approach ventriculoperitoneal shunt using a silastic Chhabra system.

Treatment:

Device: Chhabra Shunt Placement

ETV/CPC

Active Comparator group

Description:

The Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) arm will comprise a standard frontal approach with flexible endoscopy.

Treatment:

Procedure: ETV/CPC