Intraventricular Hemorrhage and Post Hemorrhagic Ventricular Dilation: Natural Course, Treatment, and Outcome



Status:Completed
Conditions:Neurology, Women's Studies
Therapuetic Areas:Neurology, Reproductive
Healthy:No
Age Range:Any - 1
Updated:4/13/2015
Start Date:July 2009
End Date:December 2015
Contact:Carrie Rau, Rn
Email:carrie.rau@hsc.utah.edu
Phone:801-213-3360

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Intraventricular hemorrhage and its resultant post-hemorrhagic hydrocephalus are significant
risk factors for the development of neurodevelopmental delays in preterm infants. The
purpose of this study is to determine 1) the incidence of progressive post-hemorrhagic
ventricular dilatation (PHVD) in infants with severe intraventricular hemorrhage (IVH), 2)
the effect of ventricular dilatation on brain status (cerebral oxygenation, electrical
activity, and biomarkers of cerebral damage and repair), and 3) if using ventricular
measurements, derived from cranial ultrasound to guide removal of cerebral-spinal fluid
through an Omaya reservoir, will help resolve ventricular dilatation and decrease the need
for ventriculo-peritoneal (VP) shunt insertion. The hypothesis of this research project is
that, by using ventricular measurements to guide the frequency of CSF removal, the rate of
VP shunt insertion will be decreased in preterm infants with severe IVH and PHVD. The
investigators further hypothesize that cerebral injury, as measured by cerebrospinal fluid
(CSF) concentration of biomarkers of neuronal and glial damage and inflammation, will
decrease over time with resolution of PHVD.

When an infant has severe IVH noted on cranial ultrasound, s(he) will receive weekly
ultrasounds to evaluate progression of ventricular dilatation (standard of care). After the
infant is enrolled in this study, Near-Infrared Spectroscopy (NIRS) and Amplitude integrated
Electroencephalogram (aEEG) will be performed 1-2 times per week. After Omaya reservoir
insertion, ventricular dimensions, based on weekly (standard of care) cranial ultrasounds,
will determine frequency of CSF removal. NIRS and aEEG will continue 1-2 times per week to
coincide with CSF removal. In addition, 1-2 times per week aliquots of CSF will be stored
for evaluation of biomarkers. We will evaluate the impact of IVH and PHVD over time on
cerebral oxygenation (NIRS) and cortical electrical activity (aEGG) starting at the time of
identification of IVH and correlate these measurements to ventricular dimensions. If an
Omaya reservoir is required to control PHVD, we will use ventricular dimensions to guide the
frequency of CSF removal and continue to evaluate brain status by measuring cerebral
oxygenation (NIRS) and cortical electrical activity (aEGG).

Inclusion Criteria:

- severe IVH

- receiving weekly head ultrasounds for monitoring

Exclusion Criteria:

- no or minimal IVH
We found this trial at
1
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
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