NCT01891500 - Early iNO for Oxidative Stress, Vascular Tone and Inflammation in Babies With Hypoxic Respiratory Failure | Biotech Hunter

Timeline

Start Date

May 31, 2016

Primary Completion Date

September 18, 2019

Study Completion Date

September 19, 2019

Conditions

Persistent Fetal Circulation SyndromeHypertension, Pulmonary, of Newborn, PersistentPersistent Pulmonary Hypertension of Newborn

Interventions

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.

Trial Locations (1)

32610

Shands Hospital at the University of Florida, Gainesville