Methods of reducing the risk of mortality associated with a medical treatment

Abstract

Disclosed are methods of treatment that permit a reduction of risk of mortality in infants who are candidates for treatment with inhaled nitric oxide, by identifying a subset of such infants who are at an increased risk of mortality upon treatment with inhaled nitric oxide; also disclosed are related systems for use in administering inhaled nitric oxide and methods of distributing a pharmaceutical product.

1 - 42 . (canceled) 
     
     
         43 . A method of treatment comprising
 (a) identifying a plurality of neonates as being candidates for treatment with inhaled nitric oxide;   (b) administering 20 ppm inhaled nitric oxide to a first neonate of the plurality, wherein the race of the first neonate is black;   (c) determining that a second neonate of the plurality is of less than 27 weeks gestational age;   (d) determining that the gender of the second neonate is male;   (e) determining that the race of the second neonate is white; and   (f) excluding the second neonate from treatment with inhaled nitric oxide, based on the determination that the second neonate is a white male.   
     
     
         44 . The method of  claim 43 , further comprising determining that, because the second neonate is a white male of less than 27 weeks gestational age, the second neonate is at a higher risk of mortality upon administration of inhaled nitric oxide compared to a female or black male neonate of the same gestational age as the second neonate, and concluding that the second neonate should be excluded from treatment with inhaled nitric oxide because of that higher risk of mortality. 
     
     
         45 . The method of  claim 43 , wherein the second neonate is treated with ventilatory support and/or surfactant after being excluded from treatment with inhaled nitric oxide. 
     
     
         46 . The method of  claim 43 , wherein the second neonate does not have pulmonary hypertension. 
     
     
         47 . The method of  claim 43 , wherein the second neonate is identified as being at risk of developing bronchopulmonary dysplasia (BPD). 
     
     
         48 . The method of  claim 43 , wherein determining that the race of the second neonate is white comprises visually assessing the race of the second neonate and/or querying a relative of the second neonate about the race of the second neonate. 
     
     
         49 . The method of  claim 43 , wherein the second neonate does not have left ventricular dysfunction and is not identified as being dependent on right-to-left shunting of blood. 
     
     
         50 . A method of treatment comprising
 (a) identifying a plurality of neonates as being candidates for treatment with inhaled nitric oxide;   (b) administering 20 ppm inhaled nitric oxide to a first neonate of the plurality, wherein the gender of the first neonate is female;   (c) determining that a second neonate of the plurality is of less than 27 weeks gestational age;   (d) determining that the gender of the second neonate is male;   (e) determining that the race of the second neonate is white; and   (f) excluding the second neonate from treatment with inhaled nitric oxide, based on the determination that the second neonate is a white male.   
     
     
         51 . The method of  claim 50 , further comprising determining that, because the second neonate is a white male of less than 27 weeks gestational age, the second neonate is at a higher risk of mortality upon administration of inhaled nitric oxide compared to a female or black male neonate of the same gestational age as the second neonate, and concluding that the second neonate should be excluded from treatment with inhaled nitric oxide because of that higher risk of mortality. 
     
     
         52 . The method of  claim 50 , wherein the second neonate is treated with ventilatory support and/or surfactant after being excluded from treatment with inhaled nitric oxide. 
     
     
         53 . The method of  claim 50 , wherein the second neonate does not have pulmonary hypertension. 
     
     
         54 . The method of  claim 50 , wherein the second neonate is identified as being at risk of developing BPD. 
     
     
         55 . The method of  claim 50 , wherein determining that the race of the second neonate is white comprises visually assessing the race of the second neonate and/or querying a relative of the second neonate about the race of the second neonate. 
     
     
         56 . The method of  claim 50 , wherein the second neonate does not have left ventricular dysfunction and is not identified as being dependent on right-to-left shunting of blood. 
     
     
         57 . A method of treatment comprising
 (a) identifying a neonate as being a candidate for treatment with inhaled nitric oxide;   (b) determining that the neonate is a male;   (c) visually assessing the race of the neonate and/or querying a relative of the neonate about the race of the neonate, thereby determining that the race of the neonate is white;   (d) excluding the neonate from treatment with inhaled nitric oxide, based on the determination that the neonate is a white male; and   (e) providing ventilatory support to the neonate.   
     
     
         58 . The method of  claim 57 , wherein the ventilatory support is high-frequency oscillatory ventilation. 
     
     
         59 . The method of  claim 57 , wherein the neonate is treated with surfactant. 
     
     
         60 . The method of  claim 57 , wherein the neonate does not have left ventricular dysfunction and is not identified as being dependent on right-to-left shunting of blood. 
     
     
         61 . The method of  claim 57 , wherein the neonate is identified as being at risk of developing BPD. 
     
     
         62 . The method of  claim 57 , further comprising
 determining that the neonate is a white male of less than 27 weeks gestational age and is at a higher risk of mortality upon administration of inhaled nitric oxide compared to a female or black, male neonate of the same gestational age as the white, male neonate; and   concluding that the white, male neonate should be excluded from treatment with inhaled nitric oxide because of that higher risk of mortality.