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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Utah
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00957840
First received: August 11, 2009
Last updated: June 16, 2014
Last verified: June 2014

August 11, 2009
June 16, 2014
July 2009
December 2014   (final data collection date for primary outcome measure)
Measure cerebral oxygenation using NIRS and background cerebral electrical activity using aEEG starting at the time of identification of severe IVH to better assess impact of IVH, PHVD, and CSF removal on brain status. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00957840 on ClinicalTrials.gov Archive Site
  • Use ventricular measurements to guide frequency of CSF removal. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Measure concentration of neuroproteins, such as S100B, GFAP, NSE, TGF-ß, and IL-6, in CSF over time and correlate these markers of cellular damage and inflammation with cerebral oxygenation, electrical activity, and need for VP shunt insertion. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Compare the sensitivity and reliability of the different measurement techniques used to determine ventricular dimensions [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Determine the incidence of progressive PHVD in preterm infants with severe IVH. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intraventricular Hemorrhage and Post Hemorrhagic Ventricular Dilation: Natural Course, Treatment, and Outcome
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).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Intraventricular Hemorrhage
  • Premature Infants
Procedure: NIRS, aEEG, and CSF concentration of biomarkers
NIRS and aEEg will be done twice weekly, and CSF will be analyzed with each reservoir tap
Omaya reservoir group- observational
These infants have been identified with severe enough post hemorrhagic ventricular dilation (PHVD) that they require a reservoir placed for serial cerebro-spinal fluid (CSF) removal. There is no randomization, and infants are compared to a baseline. Observational data will be collected to include NIRS and aEEg which will be done twice weekly, and CSF will be analyzed with each reservoir tap for protein biomarkers.
Intervention: Procedure: NIRS, aEEG, and CSF concentration of biomarkers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • severe IVH
  • receiving weekly head ultrasounds for monitoring

Exclusion Criteria:

  • no or minimal IVH
Both
up to 1 Year
No
Contact: Carrie Rau, Rn 801-213-3360 carrie.rau@hsc.utah.edu
Contact: Joanna Beachy, PhD, MD 801.587.7506 joanna.beachy@hsc.utah.edu
United States
 
NCT00957840
36114
No
Joanna Beachy Ph.D., M.D, University of Utah Neonatology
University of Utah
Not Provided
Principal Investigator: Joanna Beachy, PhD, MD University of Utah
University of Utah
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP