Early iNO for Oxidative Stress, Vascular Tone and Inflammation in Babies With Hypoxic Respiratory Failure
Status:
Withdrawn
Trial end date:
2019-09-19
Target enrollment:
Participant gender:
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.