Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension

Prior treatment

• Neonates whose mother has been treated with anticoagulant therapies during pregnancy.
• ECMO is urgently needed, or neonate has received ECMO.
• Active seizures while receiving anticonvulsants.

Other illness

• Life-threatening abnormality (cranial, cardiac, thoracic).
• Congenital heart defect (other than patent ductus arteriosus or small atrial septal defect).
• Significant bleeding diathesis such as grade IV intraventricular hemorrhage or periventricular leukomalacia, pulmonary hemorrhage, uncontrolled bleeding or hemodynamic failure.

Lab values

• Receiving nitric oxide donor agents such as prilocaine, sodium nitroprusside, nitroglycerin, and sulfonamides.

Other

• Neonates dependent on right-to-left shunting of blood.
• Echocardiography confirmed left-to-right shunt or left ventricular dysfunction.
• Patient is at risk of imminent death (death expected within 24 hours).
• Chromosomal abnormality.
• Congenital diaphragmatic hernia
• Neonate has been resuscitated requiring chest compressions within 6 hours of study treatment start.
• Disseminated intravascular coagulopathy.
• Experienced prolong asphyxia with evidence of severe acidosis (pH\<7.25)
• Other subjects determined by the investigator to be unsuitable for inclusion.

• Neonates ≥ 34 weeks gestation age.
• Hypoxic respiratory failure requiring more than 24 hours of ventilatory support.
• Clinical or echocardiographic evidence of pulmonary hypertension (systolic pulmonary arterial pressure \[sPAP\] \> 35 mm Hg or \> 2/3 systemic blood pressure \[SBP\] or there is a right-to-left shunt at the atrium or arterial ductus).
• Age less than 7 days at the time of treatment initiation with study drug.
• The neonatal guardian agrees to participate in the study and signs an informed consent form (ICF).