NCT01891500

Early iNO for Oxidative Stress, Vascular Tone and Inflammation in Babies With Hypoxic Respiratory Failure

Effect of Early iNO on Oxidative Stress, Vascular Tone and Inflammation in Term and Late-Preterm Infants With Hypoxic Respiratory Failure

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 30 Minutes – 48 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Fetal Circulation Syndrome
• Hypertension, Pulmonary, of Newborn, Persistent
• Persistent Pulmonary Hypertension of Newborn

Interventions

Type	Name	Description
DRUG	Inhaled nitric oxide	Drug is initiated at 20ppm. Patients randomized to receive iNO at OI 10-15.
DRUG	Nitrogen Gas	Placebo gas (bioinert), Patients randomized to bioinert inhaled gas at OI 10-15.
DRUG	Crossover iNO	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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-09-18
• Completion: 2019-09-19
• First posted: 2013-07-03
• Last updated: 2020-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study