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| ID | Type | Description | Link |
|---|---|---|---|
| 00089105 | Other Identifier | RAC | |
| OCR17867 | Other Identifier | Universiy of Florida |
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Difficult to identify subjects who meet enrollment criteria.
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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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The investigators in this study are concerned about the harmful effects of oxygen exposure in newborn infants, particularly at high concentrations. Inhaled nitric oxide (iNO) is an FDA approved drug for the treatment of hypoxic respiratory failure (HRF) in term and late-preterm babies greater than 34 weeks gestation. Hypoxic respiratory failure occurs when a patient's lungs cannot get enough oxygen into their bloodstream. This condition is traditionally treated with high concentrations of oxygen and most often requires the patient be placed on a ventilator (breathing machine). The administration of inhaled nitric oxygen directly into the lungs often improves blood oxygen levels and allows caretakers to reduce the amount of oxygen given to the baby. The purpose of this research study is to evaluate if giving the inhaled nitric oxide earlier in the course of disease improves the effectiveness of the drug, reduces the amount of cellular injury from oxygen exposure, and decreases the total amount of time a patient requires supplemental oxygen. This study uses an FDA approved drug in a new manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early inhaled nitric oxide | Experimental | Patients randomized to receive iNO at OI 10-15. |
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| Bioinert inhaled gas (nitrogen gas) | Placebo Comparator | Patients randomized to bioinert inhaled gas at OI 10-15. |
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| Crossover iNO | Active Comparator | Patients who deteriorate (OI >20 on two consecutive blood gases) will be unblinded. If they are receiving placebo gas, they will be started on iNO and make up the crossover cohort. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled nitric oxide | Drug | Drug is initiated at 20ppm. Patients randomized to receive iNO at OI 10-15. |
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| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers of oxidative injury. | Early administration of iNO to infants with HRF will result in reduced hyperoxia-mediated oxidative injury as measured by known biomarkers of oxygen free radical injury, including malondialdehyde and 8-hydroxy-2'-deoxyguanosine. | Urine samples will be collected upon enrollment and then at specific time points within the first 48 hours of study intervention to compare the change in biomarker concentrations from baseline up to hour 48. |
| Measure | Description | Time Frame |
|---|---|---|
| Responsiveness to study treatment. | Earlier administration of iNO to infants with HRF/PPHN (persistent pulmonary hypertension of the newborn) will lessen reactive oxygen species formation resulting in improved responsiveness to the drug as measured by the initial changes in arterial oxygen concentration after administration of the drug. | Arterial oxygen concentration will be measured upon enrollment and at specific time points in the first 36 hours of study intervention to compare the change in arterial oxygen concentration from baseline up to hour 36. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catalina Bazacliu, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands Hospital at the University of Florida | Gainesville | Florida | 32610 | United States |
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| Nitrogen Gas | Drug | Placebo gas (bioinert), Patients randomized to bioinert inhaled gas at OI 10-15. |
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| Crossover iNO | Drug | Patients who deteriorate (OI >20 on two consecutive blood gases) will be unblinded. If they are receiving placebo gas, they will be started on iNO and make up the crossover cohort. |
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| Expression of endothelin-1. | Earlier treatment with iNO may potentiate pulmonary vasodilation by modulating endothelin-1 expression. | Concentration of endothelin-1 will be measured upon enrollment and at specific time points in the first 36 hours of study intervention to compare the change in concentration from baseline up to hour 36. |
| Markers of inflammation. | Early iNO may up-regulate production of endogenous anti-inflammatory eicosanoids such as PGE2 (prostaglandin E2). Additionally, avoidance of hyperoxia in these patients may mitigate pro-inflammatory cytokines known to potentiate lung injury. | Concentrations of pro and anti-inflammatory markers will be measured upon enrollment and at specific time points in the first 36 hours of study intervention to compare the change in concentrations from baseline up to hour 36. |
| Duration of oxygen treatment. | Early administration of iNO to infants with HRF will result in at least a 15% reduction in total days of oxygen therapy. | Participants will be followed for the duration of their hospital stay, with an expected average stay of 4 weeks. |
| Expression of VEGF (vascular endothelial growth factor). | Earlier treatment with iNO may potentiate pulmonary vasodilation by preventing hyperoxic down regulation of VEGF. | Concentration of VEGF will be measured upon enrollment and at specific time points in the first 36 hours of study intervention to compare the change in concentration from baseline up to hour 36. |
| ID | Term |
|---|---|
| D010547 | Persistent Fetal Circulation Syndrome |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D045462 | Endothelium-Dependent Relaxing Factors |
| D009584 | Nitrogen |
| ID | Term |
|---|---|
| D014665 | Vasodilator Agents |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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