Shunt Outcomes of Post-Hemorrhagic Hydrocephalus (SOPHH)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Shunt Outcomes of Post-Hemorrhagic Hydrocephalus: A Network Pilot Study|
- Specific Aim I: Proportion of temporization [ Time Frame: 5 years ] [ Designated as safety issue: No ]The proportion of all infants entering the study who meet the criteria for surgical temporization.
- Specific Aim 2: Conversion proportion [ Time Frame: 5 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Surgery checklist scores of individual surgeon performance in standardized procedures.
- Protocol adherence [ Time Frame: 5 years ] [ Designated as safety issue: No ]Protocol adherence by network, center, surgeon, decision rubric, and individual decision data points.
- CSF Infection [ Time Frame: 5 years ] [ Designated as safety issue: No ]Incidence of CSF infection while on the protocol.
- Neurodevelopmental Outcomes [ Time Frame: 7 years ] [ Designated as safety issue: No ]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 months of age.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||August 2020|
|Estimated Primary Completion Date:||January 2018 (Final data collection date for primary outcome measure)|
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 in patients who undergo BSID-III testing at their clinical centers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480349
|Contact: Marcie Langleyfirstname.lastname@example.org|
|United States, Alabama|
|Children's Hospital of Alabama||Recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Amita Bey, MPH 205-939-9474 Amita.Bey@childrensal.org|
|Principal Investigator: Curtis Rozzelle, MD|
|United States, Missouri|
|St. Louis Children's Hospital||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Contact: Deanna Mercer 314-454-5498 email@example.com|
|Sub-Investigator: David Limbrick, MD, PhD|
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh of UPMC||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15224|
|Contact: Arlene M Luther, BS, RN 412-692-9965 firstname.lastname@example.org|
|Sub-Investigator: Mandeep S Tamber, MD, PhD|
|United States, Texas|
|Texas Children's Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Sheila Ryan, MPH, JD 832-822-4074 email@example.com|
|Sub-Investigator: William Whitehead, MD|
|United States, Utah|
|Primary Children's Medical Center||Recruiting|
|Salt Lake City, Utah, United States, 84113|
|Contact: Tracey Bach, BS 801-662-5344 firstname.lastname@example.org|
|Sub-Investigator: Jay Riva-Cambrin, MD|
|United States, Washington|
|Seattle Children's Hospital||Recruiting|
|Seattle, Washington, United States, 98105|
|Contact: Amy Anderson, BSN, RN 206-987-5916 email@example.com|
|Sub-Investigator: Samuel R Browd, MD, PhD|
|Sub-Investigator: Tamara D Simon, MD, MSPH|
|Sick Children's Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G1X8|
|Contact: Brittany Aziz 416-813-7600 ext 28771 firstname.lastname@example.org|
|Contact: Maria Lamberti-Pasculli 416-813-6456|
|Sub-Investigator: Abhaya Kulkarni, MD, PhD|
|Study Chair:||John C Wellons, III, MD||Vanderbilt University|
|Principal Investigator:||Jay Riva-Cambrin, MD, MSc||Primary Children's Hospital|
|Principal Investigator:||William E Whitehead, MD, MPH||Texas Children's Hospital|
|Principal Investigator:||Abhaya Kulkarni, MD, PhD||Sick Children's Hospital|
|Principal Investigator:||Samuel R Browd, MD, PhD||Seattle Children's Hospital|
|Principal Investigator:||Tamara D Simon, MD, MSPH||Seattle Children's Hospital|
|Principal Investigator:||David Limbrick, MD, PhD||St. Louis Children's Hospital|
|Principal Investigator:||Mandeep S Tamber, MD, PhD||Children's Hospital of Pittsburgh of UPMC|
|Principal Investigator:||John Kestle, MD||Chair, Hydrocephalus Clinical Research Network|
|Principal Investigator:||Chevis N Shannon, MBA, DrPH||Vanderbilt University|
|Principal Investigator:||Curtis Rozzelle, MD||Children's Hospital of Alabama|