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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Hospital for Sick Children
Penn State University
CURE Children's Hospital, Uganda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2013

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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