Improving Infant Hydrocephalus Outcomes in Uganda

Study Overview
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Brief Summary
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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.

Official Title
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Improving Infant Hydrocephalus Outcomes in Uganda: Predicting Developmental Outcomes and Identifying Patients at Risk for Early Treatment Failure After ETV/CPC

Conditions
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Hydrocephalus

Intervention / Treatment
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* Procedure: ETV/CPC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 180 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hydrocephalus group<br>Inclusion criteria: Age less than six months 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 | Procedure: ETV/CPC<br>* The Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) will comprise a standard frontal approach with flexible endoscopy.<br>|
| Control group<br>Inclusion criteria: Born at GA ≥ 37 weeks Age less than six months at the time of enrollment No known medical conditions With a parent or a guardian qualified by Ugandan law to give informed consent Parents live in one of the villages in the Mbale or Budaka District, in geographic proximity to CCHU. Exclusion criteria: Born at GA < 37 weeks Age greater than six months Evidence of one or more medical conditions Living outside of the districts specified in the inclusion criteria. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. 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. | 6 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydrocephalus