Shunt Outcomes of Post-Hemorrhagic Hydrocephalus
SOPHH
3 other identifiers
observational
146
2 countries
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2011
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2011
CompletedFirst Submitted
Initial submission to the registry
November 23, 2011
CompletedFirst Posted
Study publicly available on registry
November 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2016
CompletedDecember 26, 2017
December 1, 2017
5.3 years
November 23, 2011
December 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Specific Aim I: Proportion of temporization
The proportion of all infants entering the study who meet the criteria for surgical temporization.
5 years
Specific Aim 2: Conversion proportion
The proportion of all infants with SGS or RES who met criteria for conversion to permanent shunt.
5 years
Specific Aim 3: Surgery Checklist Scores
Surgery checklist scores of individual surgeon performance in standardized procedures.
5 years
Secondary Outcomes (3)
Protocol adherence
5 years
CSF Infection
5 years
Neurodevelopmental Outcomes
7 years
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Less than 72 hour life expectancy from other medical problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Sick Children's Hospital
Toronto, Ontario, M5G1X8, Canada
Related Links
Study Officials
- STUDY CHAIR
John C Wellons, III, MD
Vanderbilt University Medical Center
- PRINCIPAL INVESTIGATOR
Chevis N Shannon, MBA, DrPH
Vanderbilt University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2011
First Posted
November 28, 2011
Study Start
January 10, 2011
Primary Completion
May 10, 2016
Study Completion
May 10, 2016
Last Updated
December 26, 2017
Record last verified: 2017-12