Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation

NACompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

January 31, 2017

Study Completion Date

May 1, 2017

Conditions
Respiratory Distress Syndrome in Premature InfantsVery Low Birth Weight Baby
Interventions
DRUG

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.

OTHER

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.

Trial Locations (2)

73104

University of Oklahoma Health Sciences Center, Oklahoma City

University of Oklahoma, Childrens Hospital, Oklahoma City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mallinckrodt

INDUSTRY

lead

University of Oklahoma

OTHER