Hydrocephalus
Conditions
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.
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.
Interventions
DEVICEChhabra Shunt Placement
PROCEDUREETV/CPC
Sponsors
Boston Children's Hospital
Penn State University
The Hospital for Sick Children
CURE Children's Hospital, Uganda
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 180 Days
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Uganda
Contacts
PRINCIPAL_INVESTIGATORBenjamin C Warf, MD
Boston Children's Hospital
Outcome results
None listed