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

Volumn 21, Issue 5, 2008, Pages 411-422

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

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^b ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^c Pfizer Global Pharmaceuticals   (United States)

^d NONE

Author keywords

GH; Predictors of response; Small for gestational age

Indexed keywords

CHOLESTEROL; HUMAN GROWTH HORMONE; SOMATOMEDIN BINDING PROTEIN 3; SOMATOMEDIN C;

ARTICLE; ASTHMA; BIRTH WEIGHT; BODY COMPOSITION; BODY HEIGHT; BONE AGE; BRONCHIOLITIS; CHILD; CHOLESTEATOMA; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEHYDRATION; DRUG DOSE INCREASE; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; DRUG WITHDRAWAL; FANCONI ANEMIA; FEMALE; FEVER; FOOD AND DRUG ADMINISTRATION; GROWTH RATE; HUMAN; HYPERGLYCEMIA; LEUKOCYTE COUNT; LEUKOCYTOSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OPEN STUDY; OTITIS MEDIA; PNEUMONIA; PREDICTION; PREPUBERTY; RHEUMATIC FEVER; SCORING SYSTEM; SINGLE BLIND PROCEDURE; SMALL FOR DATE INFANT; UNDERWEIGHT; UNITED STATES; UPPER RESPIRATORY TRACT INFECTION; VIRAL GASTROENTERITIS; VOMITING;

EID: 46049106960     PISSN: 0334018X     EISSN: None     Source Type: Journal    
DOI: 10.1515/JPEM.2008.21.5.411     Document Type: Article

References (32)

1. Boguszewski M, Albertsson-Wikland K, Aronsson S, Gustafsson J, Hagenas L, Westgren U, Westphal O, Lipsanen-Nyman M, Sipila I, Gellert P, Muller J, Madsen B. Growth hormone treatment of short children born small-for-gestational-age: the Nordic Multicentre Trial. Acta Paediatr 1998; 87: 257-263.
2. Chernausek SD, Breen TJ, Frank GR. Linear growth in response to growth hormone treatment in children with short stature associated with intrauterine growth retardation: the National Cooperative Growth Study experience. J Pediatr 1996; 128: S22-27.
3. Czernichow P. Growth hormone treatment of short children born small for gestational age. Acta Paediatr Suppl 1997; 423: 213-215.
4. de Zegher F, Albertsson-Wikland K, Wollmann HA, Chatelain P, Chaussain JL, Lofstrom A, Jonsson B, Rosenfeld RG. Growth hormone treatment of short children born small for gestational age: growth responses with continuous and discontinuous regimens over 6 years. J Clin Endocrinol Metab 2000; 85: 2816-2821.
5. Fjellestad-Paulsen A, Czernichow P, Brauner R, Bost M, Colle M, Lebouc JY, Lecornu M, Leheup B, Limal JM, Raux MC, Toublanc JE, Rappaport R. Three-year data from a comparative study with recombinant human growth hormone in the treatment of short stature in young children with intrauterine growth retardation. Acta Paediatr 1998; 87: 511-517.
6. Sas T, de Waal W, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Growth hormone treatment in children with short stature born small for gestational age: 5-year results of a randomized, double-blind, dose-response trial. J Clin Endocrinol Metab 1999; 84: 3064-3070.
7. Battaglia FC, Lubchenco LO. A practical classification of newborn infants by weight and gestational age. J Pediatr 1967; 71: 159-163.
8. Hokken-Koelega ACS, De Ridder MAJ, Lemmen RJ, Den Hartog H, De Muinck Keizer-Schrama SMPF, Drop SL. Children born small for gestational age: do they catch-up? Pediatr Res 1995; 38: 267-271.
9. Usher R, McLean F. Intrauterine growth of live-born Caucasian infants at sea level: standards obtained from measurements in 7 dimensions of infants born between 25 and 44 weeks of gestation. J Pediatr 1969; 74: 901-910.
10. Clayton PE, Cianfarani S, Czernichow P, Johannsson G, Rapaport R, Rogol A. Management of the child born small for gestational age through to adulthood: a consensus statement of the International Societies of Pediatric Endocrinology and the Growth Hormone Research Society. J Clin Endocrinol Metab 2007; 92: 804-810.
11. Ranke MB, Lindberg A, Cowell CT, Wikland KA, Reiter EO, Wilton P, Price DA. Prediction of response to growth hormone treatment in short children born small for gestational age: analysis of data from KIGS (Pharmacia International Growth Database). J Clin Endocrinol Metab 2003; 88: 125-131.
12. Hofman PL, Cutfield WS, Robinson EM, Bergman RN, Menon RK, Sperling MA, Gluckman PD. Insulin resistance in short children with intrauterine growth retardation. J Clin Endocrinol Metab 1997; 82: 402-406.
13. Leger J, Levy-Marchal C, Bloch J, Pinet A, Chevenne D, Porquet D, Collin D, Czemichow P. Reduced final height and indications for insulin resistance in 20 year olds born small for gestational age: regional cohort study. Br Med J 1997; 315: 341-347.
14. Sas T, Mulder P, Aanstoot HJ, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Carbohydrate metabolism during long-term growth hormone treatment in children with short stature born small for gestational age. Clin Endocrinol (Oxf) 2001; 54: 243-251.
15. Hovi P, Andersson S, Eriksson JG, Järvenpää AL, Strang-Karlsson S, Mäkitie O, Kajantie E. Glucose regulation in young adults with very low birth weight. N Engl J Med 2007; 356: 2053-2063.
16. de Zegher F, Ong K, van Helvoirt M, Mohn A, Woods K, Dunger D. High-dose growth hormone (GH) treatment in non-GH-deficient children born small for gestational age induces growth responses related to pretreatment GH secretion and associated with a reversible decrease in insulin sensitivity. J Clin Endocrinol Metab 2002; 87: 148-151.
17. Hokken-Koelega AC, van Pareren Y, Sas T, Arends N. Final height data, body composition and glucose metabolism in growth hormone-treated short children born small for gestational age. Horm Res 2003; 60: 113-114.
18. Greulich WW, Pyle SI. Radiographic Atlas of Skeletal Development of the Hand and Wrist, 2nd Ed. Stanford, CA: Stanford University Press, 1959.
19. Prader A. Testicular size: assessment and clinical importance. Triangle 1966; 7: 240-243.
20. Tanner JM, Whitehouse RH. Clinical longitudinal standards for height, weight, height velocity, weight velocity, and stages of puberty. Arch Dis Child 1976; 51: 170-179.
21. U.S. Department of Health and Human Services CfDCaP 2000 National Center for Health Statistics, 2000.
22. Matthews DR, Connolly AA, Holman RR, Turner RC. Physiology of insulin secretion: problems of quantity and timing. Neth J Med 1985; 28: 20-24.
23. Katz A, Nambi SS, Mather K, Baron AD, Follmann DA, Sullivan G, Quon MJ. Quantitative insulin sensitivity check index: a simple, accurate method for assessing insulin sensitivity in humans. J Clin Endocrinol Metab 2000; 85: 2402-2410.
24. Weisberg S. Applied Linear Regression. New York: John Wiley & Sons, Inc., 1980.
25. Keskin M, Kurtoglu S, Kendirci M, Atabek ME, Yazici C. Homeostasis model assessment is more reliable than the fasting glucose/insulin ratio and quantitative insulin sensitivity check index for assessing insulin resistance among obese children and adolescents. Pediatrics 2005; 115: e500-503.
26. Ranke MB, Guilbaud O, Lindberg A, Cole T. Prediction of the growth response in children with various growth disorders treated with growth hormone: analyses of data from the Kabi Pharmacia International Growth Study. International Board of the Kabi Pharmacia International Growth Study. Acta Paediatr 1993; 82 (Suppl 391): 82-88.
27. Ranke MB, Lindberg A, Chatelain P, Wilton P, Cutfield W, Albertsson-Wikland K, Price DA. Derivation and validation of a mathematical model for predicting the response to exogenous recombinant human growth hormone (GH) in prepubertal children with idiopathic GH deficiency. KIGS International Board. Kabi Pharmacia International Growth Study. J Clin Endocrinol Metab 1999; 84: 1174-1183.
28. Sas T, Mulder P, Hokken-Koelega A. Body composition, blood pressure, and lipid metabolism before and during long-term growth hormone (GH) treatment in children with short stature born small for gestational age either with or without GH deficiency. J Clin Endocrinol Metab 2000; 85: 3786-3792.
29. Blissett J, Harris G, Kirk J. Effect of growth hormone therapy on feeding problems and food intake in children with growth disorders. Acta Paediatr 2000; 89: 644-649.
30. Kaplowitz PB, Rundle AC, Blethen SL. Weight relative to height before and during growth hormone therapy in prepubertal children. Horm Metab Res 1998; 30: 565-569.
31. Leger J, Garel C, Fjellestad-Paulsen A, Hassan M, Czernichow P. Human growth hormone treatment of short-stature children born small for gestational age: effect on muscle and adipose tissue mass during a 3-year treatment period and after 1 year's withdrawal. J Clin Endocrinol Metab 1998; 83: 3512-3516.
32. Finken MJJ, Dekker FW, de Zegher F, Wit JM; Dutch Project on Preterm and Small-for-Gestational-Age-19 Collaborative Study Group. Long-term height gain of prematurely born children with 'neonatal growth restraint: parallellism with the growth pattern of short children born small for gestational age. Pediatrics 2006; 118: 640-643.