Cerebral Perfusion, Oxygenation, Electrical Activity
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Purpose
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:
- middle cerebral artery velocity time integral and resistive index using Doppler ultrasonography
- cerebral oxygenation using near infrared spectroscopy (NIRS)
- 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.
| Condition |
|---|
|
Post-Hemorrhagic Hydrocephalus |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | 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 |
- Determine if decreasing ventricular volume improves middle cerebral artery flow, cerebral oxygenation, and cortical neuronal electrical activity. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To correlate CSF concentration of neuroproteins, S100B, GFAP, NSE, TGF-beta, and IL-6 with cerebral perfusion and neuronal electrical activity. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2006 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion 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.
Exclusion Criteria:
Contacts and Locations More Information
No publications provided
| Responsible Party: | Joanna Beachy Ph.D., M.D., University of Utah Pediatrics / Neonatology |
| ClinicalTrials.gov Identifier: | NCT00747682 History of Changes |
| Other Study ID Numbers: | 18833 |
| Study First Received: | September 3, 2008 |
| Last Updated: | June 22, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Utah:
|
Cerebral Perfusion, Oxygenation, Electrical Activity |
Additional relevant MeSH terms:
|
Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases Intracranial Hypertension |
ClinicalTrials.gov processed this record on May 19, 2013