Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of Arkansas National Institute of Neurological Disorders and Stroke (NINDS) |
---|---|
Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00665769 |
Annually, almost 5,000 extremely low birth weight (9 ounces to about 2 lbs) infants born in the US survive with severe bleeding in the brain (intraventricular hemorrhage); this devastating complication of prematurity is associated with many problems, including mental retardation, cerebral palsy, and learning disabilities, that result in profound individual and familial consequences. In addition, lifetime care costs for these severely affected infants born in a single year exceed $3 billion. The huge individual and societal costs underscore the need for developing care strategies that may limit severe bleeding in the brain of these tiny infants. The overall goal of our research is to evaluate disturbances of brain blood flow in these tiny infants in order to predict which of them are at highest risk and to develop better intensive care techniques that will limit severe brain injury.
Apparently, the heart rate of infants who eventually develop severe intraventricular hemorrhage is less variable than infants who do not develop this. We plan to test this method in a large group of infants, to be able to predict which infants are at highest risk of developing intraventricular hemorrhage and who could most benefit from interventions that would reduce disturbances of brain blood flow.
Condition | Intervention |
---|---|
Intraventricular Hemorrhage Autoregulation |
Other: Hypercapnia Other: Normocapnia |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage |
Estimated Enrollment: | 160 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | May 2013 |
Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Hypercapnic ventilation. The goal will be to maintain tcPCO2 55 mm Hg (50-60 mm Hg) and pH ≥7.20 (based on intermittent arterial blood gas determinations) during the first week of life, or until extubation. A written, laminated hypercapnic ventilator algorithm will be placed at the bedside.
|
Other: Hypercapnia
tcPCO2 50-60 mm Hg
|
B: Placebo Comparator
Normocapnic ventilation. The goal will be to maintain tcPCO2 40 mm Hg (35-45 mm Hg) and pH ≥7.25 (based on intermittent arterial blood gas determinations) during the first week of life, or until extubation. A written, laminated normocapnic ventilator algorithm will be placed at the bedside.
|
Other: Normocapnia
tcPCO2 35-45 mm Hg
|
Ages Eligible for Study: | up to 7 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeffrey R. Kaiser, MD, MA | 501-364-1056 | kaiserjeffreyr@uams.edu |
Contact: Natalie C. Sikes, RN | 501-686-7580 | sikesnataliec@uams.edu |
United States, Arkansas | |
University of Arkansas for Medical Sciences | Recruiting |
Little Rock, Arkansas, United States, 72205 | |
Contact: Jeffrey R. Kaiser, MD, MA 501-364-1056 kaiserjeffreyr@uams.edu | |
Contact: Natalie C. Sikes, RN 501-686-7580 sikesnataliec@uams.edu | |
Principal Investigator: Jeffrey R. Kaiser, MD, MA | |
University of Arkansas for Medical Sciences | Not yet recruiting |
Little Rock, Arkansas, United States, 72205 | |
Contact: Jeffrey R. Kaiser, MD, MA 501-364-1056 kaiserjeffreyr@uams.edu | |
Contact: Natalie C. Sikes, RN 501-686-7580 sikesnataliec@uams.edu | |
Principal Investigator: Jeffrey R. Kaiser, MD, MA |
Principal Investigator: | Jeffrey R. Kaiser, MD, MA | University of Arkansas |
Responsible Party: | University of Arkansas for Medical Sciences ( Pamela Valentine, Director of IRB ) |
Study ID Numbers: | 102864, 1RO1NS60674-01A1 |
Study First Received: | April 22, 2008 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00665769 History of Changes |
Health Authority: | United States: Institutional Review Board |
hypercapnia normocapnia chronic lung disease periventricular leukomalacia intraventricular hemorrhage |
hypotension cerebral autoregulation heart rate variability autonomic nervous system detrended fluctuation analysis |
Hypotension Cerebral Hemorrhage Pregnancy Complications Hypercapnia Vascular Diseases Central Nervous System Diseases Intracranial Hemorrhages Periventricular Leukomalacia |
Hemorrhage Brain Diseases Cerebrovascular Disorders Leukomalacia, Periventricular Fetal Diseases Lung Diseases Leukomalacia Infant, Newborn, Diseases |
Cerebral Hemorrhage Pregnancy Complications Nervous System Diseases Vascular Diseases Central Nervous System Diseases Intracranial Hemorrhages Hemorrhage |
Brain Diseases Cerebrovascular Disorders Fetal Diseases Pathologic Processes Infant, Newborn, Diseases Cardiovascular Diseases |