Early Inhaled Nitric Oxide for Respiratory Failure in Newborns (Early iNO)
Infant, Newborn, Hypertension, Pulmonary, Persistent Fetal Circulation Syndrome
About this trial
This is an interventional treatment trial for Infant, Newborn focused on measuring NICHD Neonatal Research Network, Hypertension, pulmonary, Hypoxic respiratory failure, Meconium aspiration, Methemoglobinemia, Nitric oxide, Oxygen inhalation therapy, Persistent Fetal Circulation Syndrome, Pneumonia, aspiration, Respiratory distress syndrome, Respiratory insufficiency, Severe respiratory failure
Eligibility Criteria
Inclusion Criteria: Infants born at >34 weeks gestational age Require assisted ventilation for hypoxic respiratory failure Have a diagnosis of primary persistent pulmonary hypertension (PPHN), respiratory distress syndrome, perinatal aspiration syndrome, pneumonia/sepsis, or suspected pulmonary hypoplasia Have an oxygenation index >15 and <25 based on 2 arterial blood gases taken at least 15 minutes apart or an Fi02 >80% In-dwelling arterial line Parental consent Exclusion Criteria: Known structural congenital heart disease, except patent ductus arteriosus and atrial level shunts Congenital diaphragmatic hernia Use of high frequency jet ventilation at the time of randomization Prior exposure to inhaled nitric oxide therapy
Sites / Locations
- University of Alabama at Birmingham
- St. Joseph's Hospital
- Stanford University
- San Diego Children's Hospital
- Yale University
- University of Miami
- Emory University
- Indiana University
- Wayne State University
- University of New Mexico
- Cincinnati Children's Medical Center
- Case Western Reserve University, Rainbow Babies and Children's Hospital
- Brown University, Women & Infants Hospital of Rhode Island
- University of Tennessee
- University of Texas Southwestern Medical Center at Dallas
- Texas Children's Hospital
- University of Texas Health Science Center at Houston
- University of Washington School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Early iNO Management
Standard iNO management
Initiation of iNO in use for term and near-term infants in respiratory failure with an oxygenation index between 15-25.
Begin a sham initiation of iNO in term and near-term infants in respiratory failure with an oxygenation index (OI) between 15-25; initiated actual iNO therapy based on standard threshold (OI >=25).