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Brain surgery showdown: which fix helps babies most?

NCT ID NCT01936272

Disease control Sponsor: Boston Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 100 Ugandan infants under 6 months old with hydrocephalus caused by a brain infection. It compares two surgeries: a standard shunt and a newer procedure called ETV/CPC. The goal is to see which treatment leads to better brain growth and thinking skills over two years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2013

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 day to 180 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hydrocephalus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hydrocephalus

Contacts and locations

Locations

  • CURE Children's Hospital Uganda

    Mbale, Uganda

More trials for these conditions

Other studies related to the condition(s) this trial covers.