Neurophysiology and Anatomy of Severe Intraventricular Hemorrhage (IVH)

Vanderbilt University

Status: Completed

Conditions: Prematurity; Intracranial Hemorrhages

Study type: Observational

Funder types: Other

Identifiers

NCT00817310

PEDNE4 ML9999 18185 04550

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: Under 14 days old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Severe IVH

Description:

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

control

Description:

infants born at less than 1500g without IVH on HUS