33
Participants
Start Date
April 30, 2011
Primary Completion Date
January 31, 2017
Study Completion Date
May 1, 2017
iNO
Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
Nitrogen
Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
University of Oklahoma Health Sciences Center, Oklahoma City
University of Oklahoma, Childrens Hospital, Oklahoma City
Collaborators (1)
Mallinckrodt
INDUSTRY
University of Oklahoma
OTHER