A Phase 3 interventional study of Chhabra Shunt Placement and ETV/CPC in Hydrocephalus, sponsored by Boston Children's Hospital. Active, not recruiting at 1 site in Uganda. Open to participants aged 1 Day to 180 Days. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Boston Children's Hospital · Phase 3, Interventional, and Treatment
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.
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.
210 studies on the registry are indexed under Hydrocephalus; 51 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 105 interventional studies indexed under Hydrocephalus.
Browse Hydrocephalus studies →Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
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Exclusion Criteria:
The shunting arm will comprise a standard frontal approach ventriculoperitoneal shunt using a silastic Chhabra system.
Device: Chhabra Shunt Placement
The Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) arm will comprise a standard frontal approach with flexible endoscopy.
Procedure: ETV/CPC
Change of Age-normed Bayley Scales of Infant Development (BSID)-III scores
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).
Time frame: 12 months and 24 months post treatment
Brain Volume
Volume unit of measure is cubic millimeters. Volume is measured using CT scans.
Time frame: 12 months, 24 months, 5 years, and 7-10 years post treatment
CSF Volume
Volume unit of measure is cubic millimeters. Volume is measured using CT scans.
Time frame: 12 months, 24 months, 5 years, and 7-10 years post treatment
Vineland Adaptive Behavior Scales
The primary purpose of the VABS is to assess the social abilities of school age children.
Time frame: 5 years and 7-10 years post treatment
Plan to share: No — IPD will not be shared with researchers outside of the study team.
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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