Neurophysiology and Anatomy of Severe Intraventricular Hemorrhage (IVH)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Intracranial Hemorrhages Prematurity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Severe IVH

Infants born at less than 1500g with diagnosis of Grade II or IV IVH

No interventions assigned to this group

control

infants born at less than 1500g without IVH on HUS

No interventions assigned to this group

Eligibility Criteria

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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

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Nathalie Maitre

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Monroe Carell Children's Hospital at Vanderbilt, NICU

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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PEDNE4 ML9999 18185 04550

Identifier Type: -

Identifier Source: org_study_id