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

Robert Rapaport, Paul Saenger, Michael P. Wajnrajch, Bruce Boston, Mauri Carakushansky, Steven Chernausek, Pamela Clark, Jay Cohen, Deborah Counts, Patricia Donohoue, John Fuqua, Mitchell Geffner, Madeleine Harbison, Dana Hardin, Perrin White, Stephen Kemp, Peter Lee, Nelly Mauras, Naomi Neufeld, Sharon Oberfield & 10 others Leslie Plotnick, Edward Reiter, Gail Richards, Samuel Richton, Robert Schultz, Lawrence Silverman, Sherida Tollefsen, Nancy Wright, Miles Yu, William Zipf

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

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. Aim: To identify pre- and within-treatment predictors of growth in well defined children born SGA treated with a fixe dose of GH. Methods: 139 short, prepubertal children born SGA (i.e. birth weight and/ or length ≥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 (Δ) height SDS at month 12 were the Δ height SDS at months 3 and 6 and growth velocity SDS at months 3 and 6. Conclusion: GH at 0.48 mg/kg/wk was well tolerated and improved growth in children born SGA; the Δ IGF-I was not predictive of the 12 month height SDS gain, while the Δ 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.

Original languageEnglish (US)
Pages (from-to)411-422
Number of pages12
JournalJournal of Pediatric Endocrinology and Metabolism
Volume21
Issue number5
StatePublished - May 2008

Fingerprint

Growth Hormone
Gestational Age
Multicenter Studies
Growth
Therapeutics
Insulin-Like Growth Factor Binding Protein 3
Human Growth Hormone
Thinness
Body Composition
Insulin-Like Growth Factor I
Birth Weight
Cholesterol
Weights and Measures
Bone and Bones
Population

Keywords

  • GH
  • Predictors of response
  • Small for gestational age

ASJC Scopus subject areas

  • Endocrinology
  • Pediatrics, Perinatology, and Child Health

Cite this

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. / Rapaport, Robert; Saenger, Paul; Wajnrajch, Michael P.; Boston, Bruce; Carakushansky, Mauri; Chernausek, Steven; Clark, Pamela; Cohen, Jay; Counts, Deborah; Donohoue, Patricia; Fuqua, John; Geffner, Mitchell; Harbison, Madeleine; Hardin, Dana; White, Perrin; Kemp, Stephen; Lee, Peter; Mauras, Nelly; Neufeld, Naomi; Oberfield, Sharon; Plotnick, Leslie; Reiter, Edward; Richards, Gail; Richton, Samuel; Schultz, Robert; Silverman, Lawrence; Tollefsen, Sherida; Wright, Nancy; Yu, Miles; Zipf, William.

In: Journal of Pediatric Endocrinology and Metabolism, Vol. 21, No. 5, 05.2008, p. 411-422.

Research output: Contribution to journalArticle

Rapaport, R, Saenger, P, Wajnrajch, MP, Boston, B, Carakushansky, M, Chernausek, S, Clark, P, Cohen, J, Counts, D, Donohoue, P, Fuqua, J, Geffner, M, Harbison, M, Hardin, D, White, P, Kemp, S, Lee, P, Mauras, N, Neufeld, N, Oberfield, S, Plotnick, L, Reiter, E, Richards, G, Richton, S, Schultz, R, Silverman, L, Tollefsen, S, Wright, N, Yu, M & Zipf, W 2008, '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', Journal of Pediatric Endocrinology and Metabolism, vol. 21, no. 5, pp. 411-422.
Rapaport, Robert ; Saenger, Paul ; Wajnrajch, Michael P. ; Boston, Bruce ; Carakushansky, Mauri ; Chernausek, Steven ; Clark, Pamela ; Cohen, Jay ; Counts, Deborah ; Donohoue, Patricia ; Fuqua, John ; Geffner, Mitchell ; Harbison, Madeleine ; Hardin, Dana ; White, Perrin ; Kemp, Stephen ; Lee, Peter ; Mauras, Nelly ; Neufeld, Naomi ; Oberfield, Sharon ; Plotnick, Leslie ; Reiter, Edward ; Richards, Gail ; Richton, Samuel ; Schultz, Robert ; Silverman, Lawrence ; Tollefsen, Sherida ; Wright, Nancy ; Yu, Miles ; Zipf, William. / 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. In: Journal of Pediatric Endocrinology and Metabolism. 2008 ; Vol. 21, No. 5. pp. 411-422.
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T2 - Results of an open-label, multicenter trial in the United States

AU - Rapaport, Robert

AU - Saenger, Paul

AU - Wajnrajch, Michael P.

AU - Boston, Bruce

AU - Carakushansky, Mauri

AU - Chernausek, Steven

AU - Clark, Pamela

AU - Cohen, Jay

AU - Counts, Deborah

AU - Donohoue, Patricia

AU - Fuqua, John

AU - Geffner, Mitchell

AU - Harbison, Madeleine

AU - Hardin, Dana

AU - White, Perrin

AU - Kemp, Stephen

AU - Lee, Peter

AU - Mauras, Nelly

AU - Neufeld, Naomi

AU - Oberfield, Sharon

AU - Plotnick, Leslie

AU - Reiter, Edward

AU - Richards, Gail

AU - Richton, Samuel

AU - Schultz, Robert

AU - Silverman, Lawrence

AU - Tollefsen, Sherida

AU - Wright, Nancy

AU - Yu, Miles

AU - Zipf, William

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N2 - 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. Aim: To identify pre- and within-treatment predictors of growth in well defined children born SGA treated with a fixe dose of GH. Methods: 139 short, prepubertal children born SGA (i.e. birth weight and/ or length ≥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 (Δ) height SDS at month 12 were the Δ height SDS at months 3 and 6 and growth velocity SDS at months 3 and 6. Conclusion: GH at 0.48 mg/kg/wk was well tolerated and improved growth in children born SGA; the Δ IGF-I was not predictive of the 12 month height SDS gain, while the Δ 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.

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