Cerebral Perfusion, Oxygenation, Electrical Activity
Alterations in Cerebral Perfusion, Oxygenation, Electrical Activity, and Markers of Cerebral Damage Associated With Cerebro-spinal Fluid Reservior Aspiration in Neonates With Post Hemorrhagic Hydrocephalus
1 other identifier
observational
30
1 country
1
Brief Summary
The specific aim of the research proposal in preterm infants with IVH and PHH who require placement of an Omaya reservoir or a shunt is to determine if decreasing ventricular volume improves, middle cerebral artery flow, cerebral oxygenation, and cortical neuronal electrical activity. To accomplish this aim, we will simultaneously perform the following evaluations prior to shunt placement or prior to and after routine CSF aspiration from reservoir in:
- 1.middle cerebral artery velocity time integral and resistive index using Doppler ultrasonography
- 2.cerebral oxygenation using near infrared spectroscopy (NIRS)
- 3.background neuronal electrical activity using an EEG. In addition, we will measure serial CSF concentration of neuroproteins, S100B, GFAP, NSE, TGF-ß, and IL-6, as evidence of ongoing neuronal damage and correlate the concentration with cerebral perfusion and activity as measured above.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2006
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 3, 2008
CompletedFirst Posted
Study publicly available on registry
September 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedJune 24, 2010
June 1, 2010
2.8 years
September 3, 2008
June 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine if decreasing ventricular volume improves middle cerebral artery flow, cerebral oxygenation, and cortical neuronal electrical activity.
1 year
Secondary Outcomes (1)
To correlate CSF concentration of neuroproteins, S100B, GFAP, NSE, TGF-beta, and IL-6 with cerebral perfusion and neuronal electrical activity.
1 year
Eligibility Criteria
Infants enrolled in this study will be identified at the time of neurosurgical evaluation for placement of a shunt or an Omaya reservoir for post-hemorrhagic hydrocephalus. Infants who have received vasoactive drugs (e.g. non-steroidal anti-inflammatory, dopamine, dobutamine, epinephrine, etc), will not be excluded from the study but the measurements will be postponed until 72 hrs after discontinuation of the medications.
You may qualify if:
- Infants enrolled in this study will be identified at the time of neurosurgical evaluation for placement of a shunt or an Omaya reservoir for post-hemorrhagic hydrocephalus. Infants who have received vasoactive drugs (e.g. non-steroidal anti-inflammatory, dopamine, dobutamine, epinephrine, etc), will not be excluded from the study but the measurements will be postponed until 72 hrs after discontinuation of the medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanna Beachy, M.D.
University of Utah
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 3, 2008
First Posted
September 5, 2008
Study Start
July 1, 2006
Primary Completion
May 1, 2009
Study Completion
August 1, 2009
Last Updated
June 24, 2010
Record last verified: 2010-06