Neurocognitive Outcomes and Changes in Brain and CSF Volume After Treatment of PIH in Ugandan Infants by Shunting vs ETV/CPC
Recruitment status was Recruiting
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.
Device: Surgical placement of Chhabra Shunt
|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|
- 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.
- 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.
|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)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01936272
|Contact: John Mugumba, MDfirstname.lastname@example.org|
|Contact: Benjamin C Warf, MDemail@example.com|
|CURE Children's Hospital Uganda||Recruiting|
|Contact: John Mugumba, MD 0454435356 firstname.lastname@example.org|
|Principal Investigator: John Mugumba, MD|
|Principal Investigator:||Benjamin C Warf, MD||Children's Hospital Boston|