Predictors of first-year growth response to a fixed-dose growth hormone treatment in children born small for gestational age: results of an open-label, multicenter trial in the United States.
BACKGROUND
Previous studies of varied populations of non-uniformly defined children born small for gestational age (SGA) receiving different growth hormone (GH) regimens have found that GH treatment increased growth velocity and adult height and was safe. The GH dose was the major predictor of first year growth response.


OBJECTIVE
To identify pre- and within-treatment predictors of growth in well defined children born SGA treated with a fixed dose of GH.


METHODS
139 short, prepubertal children born SGA (i.e. birth weight and/or length > or =2 standard deviations below the mean) received Genotropin (rhGH) at 0.24 mg/kg/wk for 1 month then an additional 11 months at a dose of 0.48 mg/kg/wk, the FDA-approved dose of GH for children born SGA.


RESULTS
Height improved significantly by month 3, with progressive improvement over the entire 12 months (median height SDS change of 0.78). Pretreatment predictors of growth included baseline bone age, IGFBP-3, total cholesterol, WBC and height SDS minus mid-parental height SDS. Within-treatment predictors of the change (Delta) height SDS at month 12 were the A height SDS at months 3 and 6 and growth velocity SDS at months 3 and 6.


CONCLUSIONS
GH at 0.48 mg/kg/wk was well tolerated and improved growth in children born SGA; the Delta IGF-I was not predictive of the 12 month height SDS gain, while the Delta height SDS at 3 and 6 months were predictive. Underweight children grew as well as normal weight children, and both groups showed improved body composition following GH treatment.
Rapaport
Robert
R
Department of Pediatrics, Mount Sinai School of Medicine, New York, New York 10029, USA. Robert.Rapaport@msnyuhealth.org
Saenger
Paul
P
Wajnrajch
Michael P
MP
D001823:Body Composition / Q000187:drug effects / Q000502:physiology; D001827:Body Height / Q000187:drug effects* / Q000502:physiology; D002648:Child; D002675:Child, Preschool; D002784:Cholesterol / Q000097:blood; D004305:Dose-Response Relationship, Drug; D005260:Female; D006128:Growth / Q000187:drug effects* / Q000502:physiology; D006130:Growth Disorders / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D013006:Growth Hormone / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D018972:Insulin-Like Growth Factor Binding Protein 3 / Q000097:blood; D008297:Male; D011237:Predictive Value of Tests; D016896:Treatment Outcome; D014481:United States
D018972:Insulin-Like Growth Factor Binding Protein 3; D013006:Growth Hormone; D002784:Cholesterol