Shunt Outcomes of Post-Hemorrhagic Hydrocephalus (SOPHH)
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ClinicalTrials.gov Identifier: NCT01480349
Recruitment Status :
First Posted : November 28, 2011
Last Update Posted : December 26, 2017
University of Utah
National Institute of Neurological Disorders and Stroke (NINDS)
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.
Condition or disease
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.
Specific Aim I: Proportion of temporization [ Time Frame: 5 years ]
The proportion of all infants entering the study who meet the criteria for surgical temporization.
Specific Aim 2: Conversion proportion [ Time Frame: 5 years ]
The proportion of all infants with SGS or RES who met criteria for conversion to permanent shunt.
Specific Aim 3: Surgery Checklist Scores [ Time Frame: 5 years ]
Surgery checklist scores of individual surgeon performance in standardized procedures.
Secondary Outcome Measures :
Protocol adherence [ Time Frame: 5 years ]
Protocol adherence by network, center, surgeon, decision rubric, and individual decision data points.
CSF Infection [ Time Frame: 5 years ]
Incidence of CSF infection while on the protocol.
Neurodevelopmental Outcomes [ Time Frame: 7 years ]
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.
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Ages Eligible for Study:
up to 180 Days (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
All premature neonates with grade III or IV intraventricular hemorrhage who primarily present or are referred prior to surgical intervention for post hemorrhagic hydrocephalus to HCRN Clinical Centers.
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
Less than 72 hour life expectancy from other medical problems