Growth Hormone Treatment of Children after Intrauterine Growth Retardation.
- Conditions
- Small for Gestational Age with persistent short stature
- Registration Number
- NL-OMON27215
- Lead Sponsor
- Prof. dr. A.C.S. Hokken-KoelegaErasmus MC SophiaRoom number SP-3437Dr. Molewaterplein 603015 GJ Rotterdama.hokken@erasmusmc.nl
- Brief Summary
Arends NJ, W VdL, Robben SG, Hokken-Koelega AC 2002 MRI findings of the pituitary gland in short children born small for gestational age (SGA) in comparison with growth hormone-deficient (GHD) children and children with normal stature. Clin Endocrinol (Oxf) 57:719-24<br> -Arends N, Johnston L, Hokken-Koelega A, et al. 2002 Polymorphism in the IGF-I gene: clinical relevance for short children born small for gestational age (SGA). J Clin Endocrinol Metab 87:2720<br> -Arends NJ, Boonstra VH, Mulder PG, et al. 2003 GH treatment and its effect on bone mineral density, bone maturation and growth in short children born small for gestational age: 3-year results of a randomized, controlled GH trial. Clin Endocrinol (Oxf) 59:779-87<br> -Boonstra V, van Pareren Y, Mulder P, Hokken-Koelega A 2003 Puberty in growth hormone-treated children born small for gestational age (SGA). J Clin Endocrinol Metab 88:5753-8<br> -Arends NJ, Boonstra VH, Hokken-Koelega AC 2004 Head circumference and body proportions before and during growth hormone treatment in short children who were born small for gestational age. Pediatrics 114:683-90<bR> -Boonstra VH, Mulder PG, de Jong FH, Hokken-Koelega AC 2004 Serum dehydroepiandrosterone sulfate levels and pubarche in short children born small for gestational age before and during growth hormone treatment. J Clin Endocrinol Metab 89:712-7<br> --Arends NJ, Boonstra VH, Duivenvoorden HJ, Hofman PL, Cutfield WS, Hokken-Koelega AC 2005 Reduced insulin sensitivity and the presence of cardiovascular risk factors in short prepubertal children born small for gestational age (SGA). Clin Endocrinol (Oxf) 62:44-50<br> -Hokken-Koelega A, van Pareren Y, Arends N, Boonstra V. 2004 Efficacy and safety of long-term continuous growth hormone treatment of children born small for gestational age.<br> Horm Res. 62 Suppl 3:149-54. Review. -Hokken-Koelega AC, De Waal WJ, Sas TC, Van Pareren Y, Arends NJ. Small for gestational age (SGA): endocrine and metabolic consequences and effects of growth hormone treatment. 2004 J Pediatr Endocrinol Metab. Mar;17 Suppl 3:463-9. <Br> -Hokken-Koelega AC, van Pareren Y, Sas T, Arends N. 2003 Final height data, body composition and glucose metabolism in growth hormone-treated short children born small for gestational age.Horm Res. ;60 Suppl 3:113-4.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 170
1. Birth weight < P3 for gestational age (according to Usher and Mc Lean);
2. Neonatal period without signs of severe asphyxia (defined as Apgar score < 3 after 5 minutes), without signs of chronic lung disease (such as bronchopulmonary dysplasia);
1. Any endocrine or metabolic disorder such as diabetes mellitus, diabetes insipidus, hypothyroidism or inborn errors of metabolism, except of GHD;
2. Disorders of genito-urinary tract, cardiopulmonary or gastrointestinal tract, or nervous systems, nutritional and/or vitamin deficiencies;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of biosynthetic GH treatment on various auxological parameters and bone maturation in comparison with a randomized untreated control group.
- Secondary Outcome Measures
Name Time Method 1. To assess the effects of biosynthetic GH treatment on bone density, lean body mass and daily food intake in comparison with a randomized untreated control group;<br /><br>2. To assess the long term efficacy of biosynthetic GH treatment on final height and other various auxological parameters;<br /><br>3. To assess the safety of GH treatment by studying the short- and long-term effects on blood pressure, carbohydrate metabolism, thyroid function.