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

Intraventricular Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957840
• Other study ID #: 36114
• Status: Completed
• Phase: N/A
• First received: August 11, 2009
• Last updated: May 5, 2015
• Start date: July 2009
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

• severe IVH

• receiving weekly head ultrasounds for monitoring

Exclusion Criteria:

• no or minimal IVH

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intraventricular Hemorrhage
• Premature Infants

Intervention

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

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 years	No
Secondary	Use ventricular measurements to guide frequency of CSF removal.		3 years	No
Secondary	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.		3 years	No
Secondary	Compare the sensitivity and reliability of the different measurement techniques used to determine ventricular dimensions		3 years	No
Secondary	Determine the incidence of progressive PHVD in preterm infants with severe IVH.		3 years	No