NCT01480349

Shunt Outcomes of Post-Hemorrhagic Hydrocephalus

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 146 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 180 Days
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Post-Hemorrhagic Hydrocephalus

Timeline

• Start date: 2011-01-10
• Primary completion: 2016-05-10
• Completion: 2016-05-10
• First posted: 2011-11-28
• Last updated: 2017-12-26

Locations

7 sites across 2 countries: United States, Canada