Shunt Outcomes of Post-Hemorrhagic Hydrocephalus

Post-Hemorrhagic Hydrocephalus Clinical Trial

— SOPHH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480349
• Other study ID #: 46249
• Secondary ID: 1RC1NS068943-01H
• Status: Completed
• Phase: N/A
• First received: November 23, 2011
• Last updated: December 21, 2017
• Start date: January 10, 2011
• Est. completion date: May 10, 2016

Study information

• Verified date: December 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: May 10, 2016
• Est. primary completion date: May 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 180 Days

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus
• Post-Hemorrhagic Hydrocephalus

Locations

Country	Name	City	State
Canada	Sick Children's Hospital	Toronto	Ontario
United States	Children's Hospital of Alabama	Birmingham	Alabama
United States	Texas Children's Hospital	Houston	Texas
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Institute of Neurological Disorders and Stroke (NINDS)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific Aim I: Proportion of temporization	The proportion of all infants entering the study who meet the criteria for surgical temporization.	5 years
Primary	Specific Aim 2: Conversion proportion	The proportion of all infants with SGS or RES who met criteria for conversion to permanent shunt.	5 years
Primary	Specific Aim 3: Surgery Checklist Scores	Surgery checklist scores of individual surgeon performance in standardized procedures.	5 years
Secondary	Protocol adherence	Protocol adherence by network, center, surgeon, decision rubric, and individual decision data points.	5 years
Secondary	CSF Infection	Incidence of CSF infection while on the protocol.	5 years
Secondary	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

External Links

•   Hydrocephalus Clinical Research Network website