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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-27

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hydrocephalus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Chhabra Shunt Placement

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

Group Type ACTIVE_COMPARATOR

Chhabra Shunt Placement

Intervention Type DEVICE

ETV/CPC

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

Group Type ACTIVE_COMPARATOR

ETV/CPC

Intervention Type PROCEDURE

Interventions

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Chhabra Shunt Placement

Intervention Type DEVICE

ETV/CPC

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

180 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No