Shunt Outcomes of Post-Hemorrhagic Hydrocephalus

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.

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

Study Location
Multiple U.S. Locations