Neurophysiology and Anatomy of Severe Intraventricular Hemorrhage (IVH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nathalie Maitre, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00817310
First received: January 5, 2009
Last updated: December 16, 2013
Last verified: December 2013
  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 Vanderbilt University:

Primary Outcome Measures:
  • neurodevelopmental outcome [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nathalie Maitre, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00817310     History of Changes
Other Study ID Numbers: PEDNE4 ML9999 18185 04550
Study First Received: January 5, 2009
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 30, 2014