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| Sponsored by: |
Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00817310 |
Purpose
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.
| Condition |
|---|
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Intracranial Hemorrhages Prematurity |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Influence of Altered Cerebral Spinal Fluid and Arterial Flows on Cerebral Processing Functions in Premature Infants With Severe Intraventricular Hemorrhage |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Severe IVH
Infants born at less than 1500g with diagnosis of Grade II or IV IVH
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control
infants born at less than 1500g without IVH on HUS
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Eligibility| Ages Eligible for Study: | up to 14 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Infants with birthweights below 1500g that are between 1 and 14 days of age
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nathalie L Maitre, MD, PhD | 615 322 4943 | nathalie.maitre@vanderbilt.edu |
| United States, Tennessee | |
| Monroe Carell Children's Hospital at Vanderbilt, NICU | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: nathalie l maitre, MD, PhD 615-322-3476 nathalie.maitre@vanderbilt.edu | |
| Principal Investigator: nathalie l maitre, MD, PhD | |
More Information
| Responsible Party: | Vanderbilt University Medical Center, Dpt of Pediatrics ( Nathalie Maitre, MD PhD ) |
| Study ID Numbers: | PEDNE4 ML9999 18185 04550 |
| Study First Received: | January 5, 2009 |
| Last Updated: | August 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00817310 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Cerebral Hemorrhage Vascular Diseases Central Nervous System Diseases Intracranial Hemorrhages |
Brain Diseases Hemorrhage Cerebrovascular Disorders |
|
Cerebral Hemorrhage Pathologic Processes Nervous System Diseases Vascular Diseases Central Nervous System Diseases |
Cardiovascular Diseases Intracranial Hemorrhages Brain Diseases Hemorrhage Cerebrovascular Disorders |
