Improving Infant Hydrocephalus Outcomes in Uganda
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|ClinicalTrials.gov Identifier: NCT03650101|
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : August 29, 2018
|Condition or disease||Intervention/treatment|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Improving Infant Hydrocephalus Outcomes in Uganda: Predicting Developmental Outcomes and Identifying Patients at Risk for Early Treatment Failure After ETV/CPC|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
- Procedure: ETV/CPC
The Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) will comprise a standard frontal approach with flexible endoscopy.
- Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score [ Time Frame: 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 [ Time Frame: 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.
- Cerebral oxygen metabolism [ Time Frame: 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 [ Time Frame: pre- and post-, 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650101
|Contact: Pei-Yi Lin, PhD||6179191308||Ivy.Lin@childrens.harvard.edu|