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

NCT00957840 | Completed

• 1 other identifier: 36114
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraventricular Hemorrhage; Premature Infants

Keywords

Omaya reservoirs; cerebral oxygenation; VP shunt; IVH; post hemorrhagic ventricular dilation (PVHD)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Use ventricular measurements to guide frequency of CSF removal.

  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.

  3 years

• Compare the sensitivity and reliability of the different measurement techniques used to determine ventricular dimensions

  3 years

• Determine the incidence of progressive PHVD in preterm infants with severe IVH.

  3 years

Study Arms (1)

Omaya reservoir group- observational

OTHER

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

Interventions

NIRS, aEEG, and CSF concentration of biomarkers PROCEDURE

NIRS and aEEg will be done twice weekly, and CSF will be analyzed with each reservoir tap

Omaya reservoir group- observational

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• severe IVH
• receiving weekly head ultrasounds for monitoring

You may not qualify if:

• no or minimal IVH

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Joanna Beachy, PhD, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 13, 2009
• Study Start: July 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 6, 2015

Record last verified: 2015-05

Locations

US (1)