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

NCT01936272 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-18

No results posted yet for this study

Summary

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.

Conditions

  • Hydrocephalus

Interventions

DEVICE

Chhabra Shunt Placement

PROCEDURE

ETV/CPC

Sponsors & Collaborators

  • Penn State University

    collaborator OTHER

  • The Hospital for Sick Children

    collaborator OTHER

  • CURE Children's Hospital, Uganda

    collaborator OTHER

  • Boston Children's Hospital

    lead OTHER

Principal Investigators

  • Benjamin C Warf, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
180 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-27
Primary Completion
2026-06-30
Completion
2026-10-31

Countries

  • Uganda

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01936272 on ClinicalTrials.gov