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 : June 29, 2018
|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 :||September 2020|
|Estimated Study Completion Date :||March 2021|
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.
- Change of Age-normed Bayley Scales of Infant Development (BSID)-III scores [ Time Frame: 12 months and 24 months post treatment ]Neurocognition will be measured using the BSID-III Cognitive Scale. Change will be assessed at 24 months post treatment from baseline score (12 months post treatment).
- Brain Volume [ Time Frame: 12 months, 24 months, and 5 years post treatment ]Volume unit of measure is cubic millimeters. Volume is measured using CT scans.
- CSF Volume [ Time Frame: 12 months, 24 months, and 5 years post treatment ]Volume unit of measure is cubic millimeters. Volume is measured using CT scans.
- Vineland Adaptive Behavior Scales [ Time Frame: 5 years post treatment ]The primary purpose of the VABS is to assess the social abilities of school age children.
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
|CURE Children's Hospital Uganda|
|Principal Investigator:||Benjamin C Warf, MD||Boston Children’s Hospital|