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Clinical Trials/NCT00817310
NCT00817310
Completed
Not Applicable

Influence of Altered Cerebral Spinal Fluid and Arterial Flows on Cerebral Processing Functions in Premature Infants With Severe Intraventricular Hemorrhage

Vanderbilt University1 site in 1 country60 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intracranial Hemorrhages
Sponsor
Vanderbilt University
Enrollment
60
Locations
1
Primary Endpoint
neurodevelopmental outcome
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
June 2011
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nathalie Maitre

Assistant Professor

Vanderbilt University

Eligibility 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

Outcomes

Primary Outcomes

neurodevelopmental outcome

Time Frame: 3 years

BSID III scores

Study Sites (1)

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