Intraventricular Hemorrhage and Post Hemorrhagic Ventricular Dilation: Natural Course, Treatment, and Outcome
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).
Allocation: Non-Randomized, Control: Historical Control, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
NIRS, aEEG, and CSF concentration of biomarkers
University of Utah
Salt Lake City
University of Utah
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00957840
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Vitamin E Deficiency
A nutritional condition produced by a deficiency of VITAMIN E in the diet, characterized by posterior column and spinocerebellar tract abnormalities, areflexia, ophthalmoplegia, and disturbances of gait, proprioception, and vibration. In premature infants vitamin E deficiency is associated with hemolytic anemia, thrombocytosis, edema, intraventricular hemorrhage, and increasing risk of retrolental fibroplasia and bronchopulmonary dysplasia. An apparent inborn error of vitamin E metabolism, named familial isolated vitamin E deficiency, has recently been identified. (Cecil Textbook of Medicine, 19th ed, p1181)
Hemorrhage within the orbital cavity, posterior to the eyeball.
Intraocular hemorrhage from the vessels of various tissues of the eye.
The delivery of a drug into a fluid-filled cavity of the brain.
Hemorrhage following any surgical procedure. It may be immediate or delayed and is not restricted to the surgical wound.
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