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

May 14, 2026 updated by: Benjamin C. Warf, Boston Children's Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Mbale, Uganda
        • CURE Children's Hospital Uganda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 5 months (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Age-normed Bayley Scales of Infant Development (BSID)-III scores
Time Frame: 12 months and 24 months post treatment
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
Time Frame: 12 months, 24 months, 5 years, and 7-10 years post treatment
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
Time Frame: 12 months, 24 months, 5 years, and 7-10 years post treatment
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
Time Frame: 5 years and 7-10 years post treatment
The primary purpose of the VABS is to assess the social abilities of school age children.
5 years and 7-10 years post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

The Hospital for Sick Children
Penn State University
CURE Children's Hospital, Uganda

Investigators

  • Principal Investigator: Benjamin C Warf, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2013

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

September 3, 2013

First Posted (Estimated)

September 6, 2013

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P00002785

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with researchers outside of the study team.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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