Cerebral Perfusion, Oxygenation, Electrical Activity

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00747682
First received: September 3, 2008
Last updated: June 22, 2010
Last verified: June 2010
  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:

  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
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

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  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
Intracranial Hypertension
Nervous System Diseases

ClinicalTrials.gov processed this record on October 22, 2014