Neurophysiology and Anatomy of Severe Intraventricular Hemorrhage (IVH)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00817310

Enrollment

Registered

2009-01-06

Start date

2009-01-31

Completion date

2011-06-30

Last updated

2013-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Hemorrhages, Prematurity

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 14 Days

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

Design outcomes

Primary

Measure	Time frame	Description
neurodevelopmental outcome	3 years	BSID III scores

Countries

United States

Outcome results