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| Sponsors and Collaborators: |
University of Chicago INO Therapeutics |
|---|---|
| Information provided by: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00152542 |
Purpose
Our previous data demonstrated that premature infants treated with inhaled nitric oxide at birth had improved neurodevelopmental outcomes at two years corrected age. We now wish to determine whether this benefit continues through school age.
| Condition | Intervention | Phase |
|---|---|---|
|
Prematurity, Respiratory Distress Syndrome,Hypoxemia |
Drug: Inhaled nitric oxide Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Follow up at School-Age of Children Participating in the Nitric Oxide Ventilatory Approach (NOVA) Study |
| Enrollment: | 160 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | May 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Inhaled nitric oxide: Experimental |
Drug: Inhaled nitric oxide
1 day of iNO at 10 ppm, then 5 ppm of iNO for days 2-7
|
| Placebo: Placebo Comparator |
Drug: Placebo
No iNO given for days 1-7
|
Two questionnaires (truncated versions of previously validated surveys), one for parent and another for teacher, for which written consent was previously obtained are being sent to parents. The teacher questionnaires will be delivered via parents. A clinic visit will accompany age appropriate neurodevelopmental examination, administration of the Functional Independence Measure for Children (WeeFIM) survey, and hearing and visual screening exams (if appropriate).
Eligibility| Ages Eligible for Study: | 4 Years to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| The University of Chicago, Comer Children's Hospital, | |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: | Michael D Schreiber, M.D. | University of Chicago |
More Information
| Responsible Party: | University of Chicago ( Michael D. Schreiber ) |
| Study ID Numbers: | 9549 (temp19), 29078 |
| Study First Received: | September 8, 2005 |
| Last Updated: | March 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00152542 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Inhaled nitric oxide, Lung recruitment, Ventilatory approach, Neurodevelopmental outcomes, School age children |
|
Neurotransmitter Agents Vasodilator Agents Antioxidants Respiratory Distress Syndrome, Adult Respiration Disorders Acute Respiratory Distress Syndrome Anti-Asthmatic Agents |
Cardiovascular Agents Nitric Oxide Respiratory Tract Diseases Lung Diseases Peripheral Nervous System Agents Bronchodilator Agents |
|
Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Respiratory Distress Syndrome, Adult Respiration Disorders Physiological Effects of Drugs Anti-Asthmatic Agents Cardiovascular Agents Protective Agents |
Pharmacologic Actions Nitric Oxide Respiratory Tract Diseases Autonomic Agents Lung Diseases Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Peripheral Nervous System Agents Bronchodilator Agents |
