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Neurophysiology and Anatomy of Severe Intraventricular Hemorrhage (IVH)

Completed
Conditions
Prematurity
Intracranial Hemorrhages
Registration Number
NCT00817310
Lead Sponsor
Vanderbilt University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
neurodevelopmental outcome3 years

BSID III scores

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Monroe Carell Children's Hospital at Vanderbilt, NICU

🇺🇸

Nashville, Tennessee, United States

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