Method and product for treatment and/or prevention of complications of prematurity

Abstract

The present invention relates to a composition comprising Insulin Growth Factor I (IGF-I) or an analog thereof in combination with Insulin Growth Factor Binding Protein (IGFBP) or an analog thereof, said combination having a molar ratio of IGF-I to IGFBP being lower than equimolar, preferably in the range from 1:20 to 1:3.33, for use in the treatment of a patient suffering from complications of preterm birth, very preterm birth and/or extremely preterm birth, as well as a method for treating a patient suffering from complications of preterm birth, very preterm birth and/or extremely preterm birth.

1 - 38 . (canceled) 
     
     
         39 . A method for reducing the risk of developing a complication of preterm birth caused by under developed lungs, digestive system, and/or nervous system comprising administering to a preterm infant having a serum level of IGF-1 and IGFBP-3 below the in utero normal for the same gestational age, a combination of IGF-1 and IGFBP-3 in amounts sufficient to elevate the preterm infant's IGF-1 and IGFBP-3 serum levels to normal in utero levels. 
     
     
         40 . The method of  claim 39 , wherein the complication of preterm birth is selected from the group consisting of developmental delay, mental retardation, bronchopulmonary dysplaysia, intraventricular hemorrhage, and retinopathy of prematurity. 
     
     
         41 . The method of  claim 40 , wherein the complication of preterm birth is bronchopulmonary dysplaysia. 
     
     
         42 . The method of  claim 39 , wherein the complication of preterm birth is retinopathy of prematurity. 
     
     
         43 . The method of  claim 39 , wherein said administering is initiated not later than three days post-birth. 
     
     
         44 . The method of  claim 39 , wherein said administering is initiated not later than five days post-birth. 
     
     
         45 . The method of  claim 39 , wherein the combination of IGF-1 and IGFBP-3 is administered intravenously or by inhalation. 
     
     
         46 . The method of  claim 39 , wherein the IGFBP-3 is recombinant human IGFBP-3 (rhIGFBP-3). 
     
     
         47 . The method of  claim 39 , wherein the IGF-I is recombinant human IGF-I (rhIGF-I). 
     
     
         48 . The method of  claim 39 , wherein the molar ratio of the IGF-1 to IGFBP-3 administered is within the range of from 1:20 to 1:3.33. 
     
     
         49 . The method of  claim 39 , wherein the complication of preterm birth is selected from the group consisting of developmental delay, mental retardation, bronchopulmonary dysplaysia, intraventricular hemorrhage, and retinopathy of prematurity. 
     
     
         50 . The method of  claim 49 , wherein the complication of preterm birth is bronchopulmonary dysplaysia. 
     
     
         51 . The method of  claim 48 , wherein said administering is initiated not later than five days post-birth. 
     
     
         52 . The method of  claim 48 , wherein the molar ratio of the IGF-1 to IGFBP-3 administered is within the range of from 1:15 to 1:5. 
     
     
         53 . The method of  claim 48 , wherein the combination of IGF-1 and IGFBP-3 is administered intravenously or by inhalation. 
     
     
         54 . The method of  claim 48 , wherein the IGFBP-3 is recombinant human IGFBP-3 (rhIGFBP-3). 
     
     
         55 . The method of  claim 48 , wherein the IGF-I is recombinant human IGF-I (rhIGF-I).