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| Sponsored by: |
INO Therapeutics |
| Information provided by: | INO Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00041548 |
Purpose
The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no significant adverse effects.
| Condition | Intervention | Phase |
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Lung Disease Hypoxemia Respiratory Acidosis |
Drug: nitric oxide for inhalation Drug: Oxygen |
Phase I Phase II |
| ChemIDplus related topics: | Nitric oxide |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation |
| Enrollment: | 7 |
| Study Start Date: | May 2002 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Nitric Oxide for Inhalation
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Drug: nitric oxide for inhalation
given at 20 ppm for 1 hour then weaned off over 4 hours
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2: Placebo Comparator
oxygen
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Drug: Oxygen
given at 20 ppm for one hour, then weaned off over four hours
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It is possible that administration of inhaled NO to neonates with abnormal gas exchange earlier, rather than later as a rescue therapy in a moribund state, might accelerate the transition of the circulation from the fetal to neonatal physiology and improve oxygenation. This may in turn decrease the need for mechanical ventilation, its associated morbidity and perhaps even ECMO.
This study is designed as a pilot study to evaluate the physiologic efficacy (rather than effect on clinical outcomes) of NO administered by hood in improving oxygenation of neonates with elevated A-a DO2.
Eligibility
| Ages Eligible for Study: | up to 120 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| United States, Alabama | |||||
| The University of Alabama Birmingham | |||||
| Birmingham, Alabama, United States, 35233 | |||||
| INO Therapeutics |
| Principal Investigator: | Waldemar Carlo, MD | University of Alabama at Birmingham |
More Information
| Responsible Party: | INO Therapeutics ( Robert Small ) |
| Study ID Numbers: | CARLW1 |
| First Received: | July 10, 2002 |
| Last Updated: | February 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00041548 |
| Health Authority: | United States: Food and Drug Administration |
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