Early iNO for Oxidative Stress, Vascular Tone and Inflammation in Babies With Hypoxic Respiratory Failure
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01891500 |
Recruitment Status
:
Recruiting
First Posted
: July 3, 2013
Last Update Posted
: March 22, 2018
|
Sponsor:
University of Florida
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
University of Florida
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | June 19, 2013 | ||||||||
First Posted Date ICMJE | July 3, 2013 | ||||||||
Last Update Posted Date | March 22, 2018 | ||||||||
Actual Study Start Date ICMJE | May 2016 | ||||||||
Estimated Primary Completion Date | November 2018 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Biomarkers of oxidative injury. [ Time Frame: 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. ] 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.
|
||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01891500 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||
Original Secondary Outcome Measures ICMJE |
|
||||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Early iNO for Oxidative Stress, Vascular Tone and Inflammation in Babies With Hypoxic Respiratory Failure | ||||||||
Official Title ICMJE | Effect of Early iNO on Oxidative Stress, Vascular Tone and Inflammation in Term and Late-Preterm Infants With Hypoxic Respiratory Failure | ||||||||
Brief Summary | 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. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 4 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
||||||||
Condition ICMJE |
|
||||||||
Intervention ICMJE |
|
||||||||
Study Arms |
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
68 | ||||||||
Original Estimated Enrollment ICMJE |
24 | ||||||||
Estimated Study Completion Date | December 2018 | ||||||||
Estimated Primary Completion Date | November 2018 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender |
|
||||||||
Ages | up to 48 Hours (Child) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
|
||||||||
Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01891500 | ||||||||
Other Study ID Numbers ICMJE | IRB201400791 00089105 ( Other Identifier: RAC ) |
||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement | Not Provided | ||||||||
Responsible Party | University of Florida | ||||||||
Study Sponsor ICMJE | University of Florida | ||||||||
Collaborators ICMJE | Mallinckrodt | ||||||||
Investigators ICMJE |
|
||||||||
PRS Account | University of Florida | ||||||||
Verification Date | March 2018 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |