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
  Purpose

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.


Condition Intervention
Intraventricular Hemorrhage
Premature Infants
Procedure: NIRS, aEEG, and CSF concentration of biomarkers

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intraventricular Hemorrhage and Post Hemorrhagic Ventricular Dilation: Natural Course, Treatment, and Outcome

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • severe IVH
  • receiving weekly head ultrasounds for monitoring

Exclusion Criteria:

  • no or minimal IVH
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00957840

Contacts
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

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Carrie Rau, RN    801-213-3360    carrie.rau@hsc.utah.edu   
Principal Investigator: Joanna Beachy, PhD, MD         
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Joanna Beachy, PhD, MD University of Utah
  More Information

No publications provided

Responsible Party: Joanna Beachy Ph.D., M.D, University of Utah Neonatology
ClinicalTrials.gov Identifier: NCT00957840     History of Changes
Other Study ID Numbers: 36114
Study First Received: August 11, 2009
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Omaya reservoirs
cerebral oxygenation
VP shunt
IVH
post hemorrhagic ventricular dilation (PVHD)

Additional relevant MeSH terms:
Cerebral Hemorrhage
Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014