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New surgery could free ugandan babies from lifelong shunts

NCT ID NCT03650101

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a surgery called ETV/CPC as an alternative to standard shunts for infants with hydrocephalus in Uganda. Shunts often fail and need lifelong maintenance, but ETV/CPC aims to give babies a shunt-free life. Researchers will follow 400 infants to see how well the surgery works and predict which children will have the best outcomes.

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.

Participants

About 400 people

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

Started

May 2021

Expected to finish

Dec 2027

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.

Who is studied

Infants less than six months old with progressive hydrocephalus

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 characterized by abnormal rate of head growth, full anterior fontanel, ventriculomegaly * A parent or a guardian qualified by Ugandan law to give informed consent * Patients from Eastern, Central and Northern districts of Uganda, and in geographic proximity to CURE hospital will be eligible Exclusion Criteria: * Age greater than six months * No evidence of progressive hydrocephalus * Patients outside of the districts specified in the inclusion criteria

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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 of Uganda

    Mbale, Uganda

  • Penn State University

    University Park, Pennsylvania, 16802, United States

  • The Hospital for Sick Children

    Toronto, Ontario, Canada

More trials for these conditions

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