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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00957840

First Posted: August 13, 2009

Last Update Posted: May 6, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

University of Utah

Tracking Information

First Submitted Date ^ICMJE

August 11, 2009

First Posted Date ^ICMJE

August 13, 2009

Last Update Posted Date

May 6, 2015

Start Date ^ICMJE

July 2009

Primary Completion Date

April 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00957840 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Use ventricular measurements to guide frequency of CSF removal. [ Time Frame: 3 years ]
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 ]
Compare the sensitivity and reliability of the different measurement techniques used to determine ventricular dimensions [ Time Frame: 3 years ]
Determine the incidence of progressive PHVD in preterm infants with severe IVH. [ Time Frame: 3 years ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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).

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Intraventricular Hemorrhage
Premature Infants

Intervention ^ICMJE

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

Study Arms

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2015

Primary Completion Date

April 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

severe IVH
receiving weekly head ultrasounds for monitoring

Exclusion Criteria:

no or minimal IVH

Sex/Gender

Sexes Eligible for Study:

All

Ages

up to 1 Year (Child)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00957840

Other Study ID Numbers ^ICMJE

36114

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Joanna Beachy Ph.D., M.D, University of Utah Neonatology

Study Sponsor ^ICMJE

University of Utah

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Joanna Beachy, PhD, MD

University of Utah

PRS Account

University of Utah

Verification Date

May 2015

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

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