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| Sponsored by: |
INO Therapeutics |
|---|---|
| Information provided by: | INO Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00551642 |
Purpose
The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy on the development of these children over 7 years of clinical follow-up.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Disease |
Drug: Nitric Oxide for inhalation Drug: Nitrogen |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | The Effects of Nitric Oxide for Inhalation on the Development of Chronic Lung Disease in Pre-Term Infants |
| Estimated Enrollment: | 800 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | March 2015 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group A
24+0-25+6 days weeks gestational age
|
Drug: Nitric Oxide for inhalation
inhaled nitric oxide given at 5ppm for 7-21 days
Drug: Nitrogen
nitrogen gas given at 5ppm for 7-21 days
|
|
Group B
26+0 - 28+6 days weeks Gestational Age
|
Drug: Nitric Oxide for inhalation
inhaled nitric oxide given at 5ppm for 7-21 days
Drug: Nitrogen
nitrogen gas given at 5ppm for 7-21 days
|
Although the effects of inhaled NO on pulmonary vascular tone are well-described and relevant to term infants with persistent pulmonary hypertension, the pathophysiology of respiratory failure in preterm infants may be quite different. Chronic lung disease (CLD) represents the final pathway of a heterogeneous group of pulmonary disorders of infancy that usually start in the neonatal period. CLD most commonly occurs in preterm (<30 weeks of gestational age (GA) infants with birth weights less than 1,500 g, and especially in those very preterm (<26 wks GA) with birth weights less than 1,000 g, and who have been treated for respiratory distress syndrome (RDS).
Eligibility| Ages Eligible for Study: | up to 26 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 35 Study Locations| Study Chair: | Jean-Christophe Mercier | Hospital Robert Debre |
More Information
| Responsible Party: | INO Therapeutics ( James Baldassarre, MD ) |
| Study ID Numbers: | INOT27, EUNO, EU Preemie |
| Study First Received: | October 30, 2007 |
| Last Updated: | September 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00551642 History of Changes |
| Health Authority: | European Union: European Medicines Agency |
|
Preemie, Inhaled Nitric Oxide |
|
Nitric Oxide Vasodilator Agents Neurotransmitter Agents Antioxidants Respiratory Tract Diseases |
Lung Diseases Anti-Asthmatic Agents Cardiovascular Agents Peripheral Nervous System Agents Bronchodilator Agents |
|
Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action 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 |