Neurophysiology and Anatomy of Severe Intraventricular Hemorrhage (IVH)

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.

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Key information

Conditions

Intracranial Hemorrhages Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Female Urogenital Diseases and Pregnancy Complications Hemorrhage Nervous System Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Prematurity Urogenital Diseases Vascular Diseases

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Monroe Carell Children's Hospital at Vanderbilt, NICU

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

neurodevelopmental outcome

Time frame: 3 years

BSID III scores

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Jan 6, 2009
Registry last updated: Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed