Inhaled Nitric Oxide Study for Respiratory Failure in Newborns (NINOS)
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: Greater than 34 wks gestational age One or more of the following diagnoses: primary pulmonary hypertension of the newborn, respiratory distress syndrome, perinatal aspiration syndrome, pneumonia/sepsis, suspected pulmonary hypoplasia Oxygenation Index (OI) greater than 15 and less than 25 on 2 arterial blood gases at least 15 min apart Indwelling arterial line Echocardiography before randomization Parental consent Exclusion Criteria: Congenital diaphragmatic hernia Known congenital heart disease Decision not to provide full therapy
Sites / Locations
- Stanford University
- Yale University
- George Washington 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
- Texas Children's Hospital
- Foothills Hospital
- Royal Alexandra Hospital
- British Columbia Children's Hospital
- Health Sciences Center
- McMaster University
- Children's Hospital of Eastern Ontario
- Montreal Children's Hospital
- Université de Sherbrooke,
- Royal University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Inhaled Nitric Oxide
Oxygen
Inhaled Nitric Oxide (iNO)
100% oxygen