Hydrocephalus
Conditions
Keywords
Hydrocephalus
Brief summary
Neonatal postinfectious hydrocephalus (PIH) is a major public health problem in East Africa.The standard treatment has long been placement of a ventriculoperitoneal shunt (VPS) but these devices require life-long maintenance and nearly all fail multiple times. Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC) is an alternate treatment to give patients a shunt-free life. In this study, the investigators aim to optimize the metrics of evaluation as quantitative prognostic indicators of treatment response and long term outcomes.
Interventions
PROCEDUREETV/CPC
The Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) will comprise a standard frontal approach with flexible endoscopy.
Sponsors
Boston Children's Hospital
The Hospital for Sick Children
CURE Children's Hospital, Uganda
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
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 characterized by abnormal rate of head growth, full anterior fontanel, ventriculomegaly * A parent or a guardian qualified by Ugandan law to give informed consent * Patients from Eastern, Central and Northern districts of Uganda, and in geographic proximity to CURE hospital will be eligible
Exclusion criteria
* Age greater than six months * No evidence of progressive hydrocephalus * Patients outside of the districts specified in the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score | 24 months of age | Scores on the BSID-3, which is used to evaluate infants and toddlers 1 to 42 months of age, range from 1 to 19, with higher scores indicating better performance; the mean (±standard deviation(SD)) score in the general population is 10±3. |
| Incidence of ETV/CPC treatment failure | 6 months post-treatment | Treatment failure or success will be determined with the use of clinical and radiographic criteria. * Treatment success will be determined as the shift in the growth of head circumference to a normal rate, as plotted on a standard growth chart; decompression of the anterior fontanel; relief of symptoms of elevated intracranial pressure, such as irritability and vomiting; resolution of down-gaze or sixth cranial nerve palsy; and a decrease or arrest in ventriculomegaly as determined on Computerized Tomography (CT). * Treatment failure will be defined as treatment-related death or the need for a second operation for infection or for the recurrence of hydrocephalus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral oxygen metabolism | pre- and post-, 6, 12 months post-treatment and 24 months of age | cerebral oxygen metabolism will be measured with near-infrared spectroscopy |
| brain volume | pre-, 6, 12 months post-treatment and 24 months of age | brain volume will be quantitatively estimated from the head CT scan |
| Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score at 12 months post-treatment | 12 months post-treatment | Scores on the BSID-3, which is used to evaluate infants and toddlers 1 to 42 months of age, range from 1 to 19, with higher scores indicating better performance; the mean (±standard deviation) score in the general population is 10±3. |
Countries
Canada, Uganda, United States
Contacts
PRINCIPAL_INVESTIGATORPei-Yi Lin, PhD
Boston Children's Hospital
Outcome results
None listed