Neurocognitive Outcomes and Changes in Brain and CSF Volume After Treatment of PIH in Ugandan Infants by Shunting vs ETV/CPC

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Children's Hospital Boston
Sponsor:
Collaborators:
Penn State University
The Hospital for Sick Children
CURE Children's Hospital Uganda
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01936272
First received: July 29, 2013
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Hydrocephalus
Device: Surgical placement of Chhabra Shunt
Procedure: ETV/CPC
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Age-normed Bayley Scales of Infant Development (BSID)-III scores [ Time Frame: 12 months post treatment ] [ Designated as safety issue: No ]
    Neurocognition will be measured using the BSID-III Cognitive Scale.


Secondary Outcome Measures:
  • Brain Volume [ Time Frame: 12 months post treatment ] [ Designated as safety issue: No ]
    Volume unit of measure is cubic millimeters. Volume is measured using CT scans.

  • CSF Volume [ Time Frame: 12 months post treatment ] [ Designated as safety issue: No ]
    Volume unit of measure is cubic millimeters. Volume is measured using CT scans.


Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chhabra Shunt Placement
The shunting arm will comprise a standard frontal approach ventriculoperitoneal shunt using a silastic Chhabra system.
Device: Surgical placement of Chhabra Shunt
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

  Eligibility

Ages Eligible for Study:   up to 180 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936272

Contacts
Contact: John Mugumba, MD 0454435356 john.mugumba@cureinternational.org
Contact: Benjamin C Warf, MD 617-355-4932 benjamin.warf@childrens.harvard.edu

Locations
Uganda
CURE Children's Hospital Uganda Recruiting
Mbale, Uganda
Contact: John Mugumba, MD    0454435356    john.mugumba@cureinternational.org   
Principal Investigator: John Mugumba, MD         
Sponsors and Collaborators
Children's Hospital Boston
Penn State University
The Hospital for Sick Children
CURE Children's Hospital Uganda
Investigators
Principal Investigator: Benjamin C Warf, MD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01936272     History of Changes
Other Study ID Numbers: P00002785
Study First Received: July 29, 2013
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board
Canada: Hospital for Sick Children Institutional Review Board
Uganda: CURE Children's Hospital Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014