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

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01936272
• Collaborator: Penn State University (Other), The Hospital for Sick Children (Other), CURE Children's Hospital, Uganda (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 150.2
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hydrocephalus	Device: Chhabra Shunt Placement; Procedure: ETV/CPC	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (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
• Actual Study Start Date: May 27, 2013
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: ETV/CPC

Outcome Measures

Primary Outcome Measures

1. Change of Age-normed Bayley Scales of Infant Development (BSID)-III scores [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).

Secondary Outcome Measures

1. Brain Volume [12 months, 24 months, 5 years, and 7-10 years post treatment]

   Volume unit of measure is cubic millimeters. Volume is measured using CT scans.

2. CSF Volume [12 months, 24 months, 5 years, and 7-10 years post treatment]

   Volume unit of measure is cubic millimeters. Volume is measured using CT scans.

3. Vineland Adaptive Behavior Scales [5 years and 7-10 years post treatment]

   The primary purpose of the VABS is to assess the social abilities of school age children.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 180 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CURE Children's Hospital Uganda	Mbale		Uganda

Sponsors and Collaborators

• Boston Children's Hospital
• Penn State University
• The Hospital for Sick Children
• CURE Children's Hospital, Uganda

Investigators

• Principal Investigator: Benjamin C Warf, MD, Boston Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Benjamin C. Warf, Professor of Neurosurgery, Hydrocephalus and Spina Bifida Chair, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT01936272
• Other Study ID Numbers: P00002785
• First Posted: Sep 6, 2013
• Last Update Posted: Aug 17, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Hydrocephalus

Study Results

No Results Posted as of Aug 17, 2022