Randomized Controlled Trial of Shunt vs ETV/CPC for PIH in Ugandan Infants
|ClinicalTrials.gov Identifier: NCT01936272|
Recruitment Status : Active, not recruiting
First Posted : September 6, 2013
Last Update Posted : March 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hydrocephalus||Device: Chhabra Shunt Placement Procedure: ETV/CPC||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|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|
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.
- 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.
- Brain Volume [ Time Frame: 12 months post treatment ]Volume unit of measure is cubic millimeters. Volume is measured using CT scans.
- CSF Volume [ Time Frame: 12 months post treatment ]Volume unit of measure is cubic millimeters. Volume is measured using CT scans.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936272
|CURE Children's Hospital Uganda|
|Principal Investigator:||Benjamin C Warf, MD||Boston Children’s Hospital|