Improving Infant Hydrocephalus Outcomes in Uganda
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Infants less than 180 days (six months) old
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Symptomatic hydrocephalus characterized by abnormal rate of head growth, full anterior fontanel, ventriculomegaly
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A parent or a guardian qualified by Ugandan law to give informed consent
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Patients from Eastern, Central and Northern districts of Uganda, and in geographic proximity to CURE hospital will be eligible
Exclusion Criteria:
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Age greater than six months
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No evidence of progressive hydrocephalus
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Patients outside of the districts specified in the inclusion criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Penn State University | University Park | Pennsylvania | United States | 16802 |
| 2 | The Hospital for Sick Children | Toronto | Ontario | Canada | |
| 3 | Cure Children's Hospital of 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: Pei-Yi Lin, PhD, Boston Children's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P00029806