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

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ClinicalTrials.gov Identifier: NCT01936272
Recruitment Status : Active, not recruiting
First Posted : September 6, 2013
Last Update Posted : March 17, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Hydrocephalus Device: Chhabra Shunt Placement Procedure: ETV/CPC Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2013
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Age-normed Bayley Scales of Infant Development (BSID)-III scores [ Time Frame: 12 months post treatment ]
    Neurocognition will be measured using the BSID-III Cognitive Scale.


Secondary Outcome Measures :
  1. Brain Volume [ Time Frame: 12 months post treatment ]
    Volume unit of measure is cubic millimeters. Volume is measured using CT scans.

  2. CSF Volume [ Time Frame: 12 months post treatment ]
    Volume unit of measure is cubic millimeters. Volume is measured using CT scans.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 180 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936272


Locations
Uganda
CURE Children's Hospital Uganda
Mbale, Uganda
Sponsors and Collaborators
Boston Children’s Hospital
Penn State University
The Hospital for Sick Children
CURE Children's Hospital, Uganda
Investigators
Principal Investigator: Benjamin C Warf, MD Boston Children’s Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Benjamin C. Warf, Professor of Neurosurgery, Hydrocephalus and Spina Bifida Chair, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01936272     History of Changes
Other Study ID Numbers: P00002785
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with researchers outside of the study team.

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases