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Neurophysiology and Anatomy of Severe Intraventricular Hemorrhage (IVH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00817310
First received: January 5, 2009
Last updated: August 11, 2009
Last verified: August 2009
History of Changes
  Purpose

Currently, when premature infants develop severe intraventricular hemorrhage (IVH), a type of intracerebral bleed, there are no proven therapeutic interventions to prevent the devastating consequences of this event. These children will be likely to develop cerebral palsy or severe cognitive delays.

The purpose of our study is to characterize differences in brain physiology, imaging, and function between premature infants with severe IVH and controls. The goals for gathering this information are to generate baseline data, which could facilitate early screening for complications of IVH in premature infants. These baseline data would also allow the design and implementation of early therapeutic interventions to help rehabilitate premature infants with severe IVH.


Condition
Intracranial Hemorrhages
Prematurity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Influence of Altered Cerebral Spinal Fluid and Arterial Flows on Cerebral Processing Functions in Premature Infants With Severe Intraventricular Hemorrhage

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Estimated Enrollment: 60
Study Start Date: January 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Severe IVH
Infants born at less than 1500g with diagnosis of Grade II or IV IVH
control
infants born at less than 1500g without IVH on HUS

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Infants with birthweights below 1500g that are between 1 and 14 days of age

Criteria

Inclusion Criteria:

  • Birth weight < 1500 grams for all inborn infants and age less than 14 post-natal days
  • Birth weight < 1500 grams for all outborn infants transferred to the VCH NICU within the first 72 hours after birth and age less than 14 post-natal days
  • Parents agree to their infant's participation and give informed written consent.

Exclusion Criteria:

  • Unable to obtain informed consent.
  • Congenital brain malformations leading to hydrocephalus
  • Genetic and metabolic disorders leading to cerebral pathology
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817310

Contacts
Contact: Nathalie L Maitre, MD, PhD 615 322 4943 nathalie.maitre@vanderbilt.edu

Locations
United States, Tennessee
Monroe Carell Children's Hospital at Vanderbilt, NICU Recruiting
Nashville, Tennessee, United States, 37232
Contact: nathalie l maitre, MD, PhD     615-322-3476     nathalie.maitre@vanderbilt.edu    
Principal Investigator: nathalie l maitre, MD, PhD            
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: Nathalie Maitre, MD PhD, Vanderbilt University Medical Center, Dpt of Pediatrics
ClinicalTrials.gov Identifier: NCT00817310     History of Changes
Other Study ID Numbers: PEDNE4 ML9999 18185 04550
Study First Received: January 5, 2009
Last Updated: August 11, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013