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| Sponsored by: |
University of Chicago |
|---|---|
| Information provided by: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00515281 |
Purpose
The purpose of this study is to determine whether inhaled nitric oxide improves the neurological outcome for premature infants.
| Condition | Intervention | Phase |
|---|---|---|
|
Prematurity Bronchopulmonary Dysplasia Intraventricular Hemorrhage Periventricular Leukomalacia |
Drug: inhaled nitric oxide Drug: oxygen |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Inhaled Nitric Oxide and Neuroprotection in Premature Infants |
| Estimated Enrollment: | 460 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Inhaled nitric oxide
|
Drug: inhaled nitric oxide
The amount of gas will be carefully controlled and adjusted to the level that best improves the function of subject's lungs. The subject will remain on the selected treatment until he/she reaches 33 weeks of gestation or no longer needs supplemental oxygen, whichever comes first.
|
| 2: Placebo Comparator |
Drug: oxygen
The amount of gas will be carefully controlled and adjusted to the level that best improves the function of the subject's lungs. The subject will remain on the selected treatment until he/she reaches 33 weeks of gestation or no longer needs supplemental oxygen, whichever comes first.
|
Eligibility| Ages Eligible for Study: | up to 72 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Raquel Gabriel-Bennewitz, MS/MBA, BSN, RN | 773-702-6210 ext 4-1730 | rgabriel@peds.bsd.uchicago.edu |
| United States, Illinois | |
| The University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Raquel Gabriel-Bennewitz, MS/MBA, BSN, RN 773-702-6210 ext 4-1730 rgabriel@peds.bsd.uchicago.edu | |
| Principal Investigator: | Michael D. Schreiber, M.D. | University of Chicago |
More Information
| Responsible Party: | The University of Chicago ( Michael D. Schreiber, M.D. ) |
| Study ID Numbers: | 15405A |
| Study First Received: | August 9, 2007 |
| Last Updated: | June 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00515281 |
| Health Authority: | United States: Food and Drug Administration |
|
prematurity nitric oxide bronchopulmonary dysplasia |
intraventricular hemorrhage periventricular leukomalacia neurodevelopment |
|
Bronchopulmonary dysplasia Cerebral Hemorrhage Vascular Diseases Central Nervous System Diseases Infant, Premature, Diseases Intracranial Hemorrhages Hemorrhage Brain Diseases Cerebrovascular Disorders |
Leukomalacia, Periventricular Nitric Oxide Bronchopulmonary Dysplasia Respiratory Tract Diseases Encephalomalacia Lung Diseases Leukomalacia Infant, Newborn, Diseases |
|
Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Cardiovascular Agents Protective Agents |
Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Cardiovascular Diseases Peripheral Nervous System Agents Bronchodilator Agents |
