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

Study Overview
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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.

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.

Official Title
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Neurocognitive Outcomes and Changes in Brain and Cerebral Spinal Fluid (CSF) Volume After Treatment of Post-Infectious Hydrocephalus (PIH) in Ugandan Infants by Shunting Versus ETV/CPC

Conditions
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Hydrocephalus

Intervention / Treatment
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* Device: Chhabra Shunt Placement
* Procedure: ETV/CPC


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 180 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chhabra Shunt Placement<br>The shunting arm will comprise a standard frontal approach ventriculoperitoneal shunt using a silastic Chhabra system. | Device: Chhabra Shunt Placement<br> <br> |
| Active Comparator: ETV/CPC<br>The Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) arm will comprise a standard frontal approach with flexible endoscopy. | Procedure: ETV/CPC<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Age-normed Bayley Scales of Infant Development (BSID)-III scores | Neurocognition will be measured using the BSID-III Cognitive Scale. Change will be assessed at 24 months post treatment from baseline score (12 months post treatment). | 12 months and 24 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain Volume | Volume unit of measure is cubic millimeters. Volume is measured using CT scans. | 12 months, 24 months, 5 years, and 7-10 years post treatment | 
| CSF Volume | Volume unit of measure is cubic millimeters. Volume is measured using CT scans. | 12 months, 24 months, 5 years, and 7-10 years post treatment | 
| Vineland Adaptive Behavior Scales | The primary purpose of the VABS is to assess the social abilities of school age children. | 5 years and 7-10 years post treatment |