Shunt Outcomes of Post-Hemorrhagic Hydrocephalus

Study Overview
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Brief Summary
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This multicenter, prospective pilot study will compare the effectiveness of two established procedures used in the treatment of post-hemorrhagic hydrocephalus in very low birth weight infants, specifically ventricular reservoirs and subgaleal shunts. The study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus.

Detailed Description
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Intraventricular hemorrhage and post-hemorrhagic hydrocephalus remain a leading cause of mortality and long-term morbidity in premature infants. The two most common temporary cerebrospinal fluid (CSF) diversion procedures are the ventriculosubgaleal shunt (SGS) and an implanted ventricular reservoir (RES) for intermittent CSF removal. These methods are physiologically very different and their comparative effectiveness in treating hydrocephalus and possibly reducing the need for an eventual permanent CSF shunt is currently not known. The goal of this pilot study is to obtain information critical for planning and executing a future randomized trial comparing SGS and RES. Specifically, this pilot study will establish inclusion criteria, define the primary outcome, and standardize the interventions in preparation for initiating a comparative trial between the SGS and RES procedures. In addition, the importance of examining the neurodevelopmental outcomes for these patients has been recognized within the neurosurgical and neuropsychological settings. Therefore, the scope of this study has been extended to include an examination of the neurodevelopmental outcomes at 18 to 22 months and at 36 to 42 months in patients who undergo BSID-III testing at their clinical centers.

Official Title
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Shunt Outcomes of Post-Hemorrhagic Hydrocephalus: A Network Pilot Study

Conditions
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Post-Hemorrhagic Hydrocephalus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: premature neonates with birth weights less than 1500 grams Grade III or IV intraventricular hemorrhage Fronto-occipital horn ratio greater than or equal to 0.50 Exclusion Criteria: Less than 72 hour life expectancy from other medical problems

Ages Eligible for Study
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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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific Aim I: Proportion of temporization | The proportion of all infants entering the study who meet the criteria for surgical temporization. | 5 years | 
| Specific Aim 2: Conversion proportion | The proportion of all infants with SGS or RES who met criteria for conversion to permanent shunt. | 5 years | 
| Specific Aim 3: Surgery Checklist Scores | Surgery checklist scores of individual surgeon performance in standardized procedures. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protocol adherence | Protocol adherence by network, center, surgeon, decision rubric, and individual decision data points. | 5 years | 
| CSF Infection | Incidence of CSF infection while on the protocol. | 5 years | 
| Neurodevelopmental Outcomes | Subscores from the Bayley Scales of Infant Development, version III (BSID-III) to include cognitive, language and motor subtests will be obtained for patients undergoing BSID-III testing at 18-22 and 36-42 months of age. | 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Hemorrhagic Hydrocephalus, Intraventricular Hemorrhage, Low Birth Weight Premature Infants