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Cerebral Perfusion, Oxygenation, Electrical Activity

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ClinicalTrials.gov Identifier: NCT00747682
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : June 24, 2010
Sponsor:
Information provided by:
University of Utah

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.

Condition or disease
Post-Hemorrhagic Hydrocephalus

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 30 participants
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
Study Start Date : July 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus




Primary Outcome Measures :
  1. Determine if decreasing ventricular volume improves middle cerebral artery flow, cerebral oxygenation, and cortical neuronal electrical activity. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747682


Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Joanna Beachy, M.D. University of Utah

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
First Posted: September 5, 2008    Key Record Dates
Last Update Posted: June 24, 2010
Last Verified: June 2010

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