Randomized Controlled Trial of Shunt vs ETV/CPC for PIH in Ugandan Infants

Hydrocephalus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01936272
• Other study ID #: P00002785
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 27, 2013
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 180 Days

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

Device:
• Chhabra Shunt Placement

Procedure:
• ETV/CPC

Locations

Country	Name	City	State
Uganda	CURE Children's Hospital Uganda	Mbale

Sponsors (4)

Lead Sponsor	Collaborator
Boston Children's Hospital	CURE Children's Hospital, Uganda, Penn State University, The Hospital for Sick Children

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 months and 24 months post treatment
Secondary	Brain Volume	Volume unit of measure is cubic millimeters. Volume is measured using CT scans.	12 months, 24 months, 5 years, and 7-10 years post treatment
Secondary	CSF Volume	Volume unit of measure is cubic millimeters. Volume is measured using CT scans.	12 months, 24 months, 5 years, and 7-10 years post treatment
Secondary	Vineland Adaptive Behavior Scales	The primary purpose of the VABS is to assess the social abilities of school age children.	5 years and 7-10 years post treatment