NCT01891500|WithdrawnPhase 4DMCFDA Drug
Study Stopped
Difficult to identify subjects who meet enrollment criteria.
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Difficult to identify subjects who meet enrollment criteria.
Effect of Early iNO on Oxidative Stress, Vascular Tone and Inflammation in Term and Late-Preterm Infants With Hypoxic Respiratory Failure
Sponsor study identifier
Secondary identifiers
OTHER · RAC
OTHER · Universiy of Florida
interventional
0
1 country
1
Study Start
May 2016
Actual (reported)Primary Completion
September 18, 2019
Actual (reported)Study Completion
September 19, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 19, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 19, 2013
Actual (reported)July 3, 2013
Actual (reported)May 2016
Actual (reported)September 18, 2019
Actual (reported)September 19, 2019
Actual (reported)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.
Responsiveness to study treatment.
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.
Patients randomized to receive iNO at OI 10-15.
Patients randomized to bioinert inhaled gas at OI 10-15.
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.
Drug is initiated at 20ppm. Patients randomized to receive iNO at OI 10-15.
Placebo gas (bioinert), Patients randomized to bioinert inhaled gas at OI 10-15.
Shands Hospital at the University of Florida
Gainesville, Florida, 32610, United States
Catalina Bazacliu, MD
University of Florida
0 participants (actual enrollment reported by the registry).
First Submitted
June 19, 2013
First Posted
July 3, 2013
Study Start
May 2016
Actual (reported)Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely
Expression of endothelin-1.
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.
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.
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).
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 18, 2019
Actual (reported)Study Completion
September 19, 2019
Actual (reported)Last Updated
January 7, 2020
Record last verified: 2020-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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