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NCT00817310 Clinical Trial

Neurophysiology and Anatomy of Severe Intraventricular Hemorrhage (IVH)

Prematurity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00817310
Other study ID # PEDNE4 ML9999 18185 04550
Secondary ID
Status Completed
Phase N/A
First received January 5, 2009
Last updated December 16, 2013
Start date January 2009
Est. completion date June 2011

Study information
Verified date December 2013
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 14 Days
Eligibility 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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Monroe Carell Children's Hospital at Vanderbilt, NICU Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary neurodevelopmental outcome BSID III scores 3 years No
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