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| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
| CURE Children's Hospital, Uganda | OTHER |
| Yale University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrocephalus group | Inclusion criteria:
Exclusion criteria:
|
| |
| Control group | Inclusion criteria:
Exclusion criteria:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETV/CPC | Procedure | The Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) will comprise a standard frontal approach with flexible endoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score | 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. | 24 months of age |
| Incidence of ETV/CPC treatment failure | Treatment failure or success will be determined with the use of clinical and radiographic criteria.
| 6 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral oxygen metabolism | cerebral oxygen metabolism will be measured with near-infrared spectroscopy | pre- and post-, 6, 12 months post-treatment and 24 months of age |
| brain volume | brain volume will be quantitatively estimated from the head CT scan |
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Inclusion Criteria:
Exclusion Criteria:
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Infants less than six months old with progressive hydrocephalus
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| Name | Affiliation | Role |
|---|---|---|
| Pei-Yi Lin, PhD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State University | University Park | Pennsylvania | 16802 | United States | ||
| The Hospital for Sick Children |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35050201 | Result | Vadset TA, Rajaram A, Hsiao CH, Kemigisha Katungi M, Magombe J, Seruwu M, Kaaya Nsubuga B, Vyas R, Tatz J, Playter K, Nalule E, Natukwatsa D, Wabukoma M, Neri Perez LE, Mulondo R, Queally JT, Fenster A, Kulkarni AV, Schiff SJ, Grant PE, Mbabazi Kabachelor E, Warf BC, Sutin JDB, Lin PY. Improving Infant Hydrocephalus Outcomes in Uganda: A Longitudinal Prospective Study Protocol for Predicting Developmental Outcomes and Identifying Patients at Risk for Early Treatment Failure after ETV/CPC. Metabolites. 2022 Jan 14;12(1):78. doi: 10.3390/metabo12010078. |
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Individual participant data will not be shared with researchers outside of the study team.
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| pre-, 6, 12 months post-treatment and 24 months of age |
| Bayley Scales of Infant Development, Third Edition (BSID-3), cognitive scaled score at 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. | 12 months post-treatment |
| Toronto |
| Ontario |
| Canada |
| Cure Children's Hospital of Uganda | Mbale | Uganda |