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Neurophysiology and Anatomy of Severe Intraventricular Hemorrhage (IVH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00817310
First Posted: January 6, 2009
Last Update Posted: December 17, 2013
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 (Responsible Party):
Nathalie Maitre, Vanderbilt University
  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:


Further study details as provided by Nathalie Maitre, Vanderbilt University:

Primary Outcome Measures:
  • neurodevelopmental outcome [ Time Frame: 3 years ]
    BSID III scores


Enrollment: 60
Study Start Date: January 2009
Study Completion Date: June 2011
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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817310


Locations
United States, Tennessee
Monroe Carell Children's Hospital at Vanderbilt, NICU
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
  More Information

Responsible Party: Nathalie Maitre, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00817310     History of Changes
Other Study ID Numbers: PEDNE4 ML9999 18185 04550
First Submitted: January 5, 2009
First Posted: January 6, 2009
Last Update Posted: December 17, 2013
Last Verified: December 2013

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