Growth Hormone Treatment of Children after Intrauterine Growth Retardation (IUGR-1 study).

Completed

• Conditions: 1. Small for gestational age (SGA); <br /> 2. Intrauterine growth retardation (IUGR).

• Registration Number: NL-OMON26748
• Lead Sponsor: ovo Nordisk A/S, Denmark

Brief Summary

1. de Waal, W.J., Hokken-Koelega, A.C., Stijnen, T., de Muinck Keizer-Schrama, S.M. & Drop, S.L. (1994) Endogenous and stimulated GH secretion, urinary GH excretion, and plasma IGF-I and IGF-II levels in prepubertal children with short stature after intrauterine growth retardation. The Dutch Working Group on Growth Hormone. Clin Endocrinol (Oxf), 41, 621-630;<br> 2. Sas, T., de Waal, W., Mulder, P., Houdijk, M., Jansen, M., Reeser, M. & Hokken-Koelega, A. (1999) 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, 84, 3064-3070;<br> 3. Sas, T., Mulder, P. & Hokken-Koelega, A. (2000) 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, 85, 3786-3792;<br> 4. Sas, T.C., Gerver, W.J., De Bruin, R., Mulder, P.G., Cole, T.J., De Waal, W. & Hokken-Koelega, A.C. (2000) Body proportions during 6 years of GH treatment in children with short stature born small for gestational age participating in a randomised, double-blind, dose-response trial. Clin Endocrinol (Oxf), 53, 675-681;<br> 5. Sas, T., Mulder, P., Aanstoot, H.J., Houdijk, M., Jansen, M., Reeser, M. & Hokken-Koelega, A. (2001) Carbohydrate metabolism during long-term growth hormone treatment in children with short stature born small for gestational age. Clin Endocrinol (Oxf), 54, 243-251;<br> 6. van Pareren, Y., Mulder, P., Houdijk, M., Jansen, M., Reeser, M. & Hokken-Koelega, A. (2003) Effect of discontinuation of growth hormone treatment on risk factors for cardiovascular disease in adolescents born small for gestational age. J Clin Endocrinol Metab, 88, 347-353;<br> 7. Van Pareren, Y., Mulder, P., Houdijk, M., Jansen, M., Reeser, M. & Hokken-Koelega, A. (2003) Adult height after long-term, continuous growth hormone (GH) treatment in short children born small for gestational age: results of a randomized, double-blind, dose-response GH trial. J Clin Endocrinol Metab, 88, 3584-3590;<br> 8. van Pareren, Y.K., Duivenvoorden, H.J., Slijper, F.S., Koot, H.M. & Hokken-Koelega, A.C. (2004) Intelligence and psychosocial functioning during long-term growth hormone therapy in children born small for gestational age. J Clin Endocrinol Metab, 89, 5295-5302;<br> 9. Bannink, E.M., van Pareren, Y.K., Theunissen, N.C., Raat, H., Mulder, P.G. & Hokken-Koelega, A.C. (2005) Quality of life in adolescents born small for gestational age: does growth hormone make a difference? Horm Res, 64, 166-174;<br> 10. Bannink, E.M., van Doorn, J., Mulder, P.G. & Hokken-Koelega, A.C. (2007) Free/Dissociable Insulin-Like Growth Factor (IGF)-I, Not Total IGF-I, Correlates with Growth Response during Growth Hormone Treatment in Children Born Small for Gestational Age. J Clin Endocrinol Metab, 92, 2992-3000.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

1. Birth length
2. Uncomplicated neonatal period, defined as no signs of:

Exclusion Criteria

1. Any endocrine or metabolic disorder (such as diabetes mellitus, diabetes insipidus, hypothyroidism, or inborn errors of metabolism);

2. Disorders of the genito-urinary tract, cardio-pulmonary or gastro-intestinal tract, or nervous system, nutritional and/or vitamin deficiencies;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess the effect of GH therapy on:<br /> <br>a. linear growth;<br /> <br>b. bone maturation;<br /> <br>c. pubertal development;<br /> <br>d. final height;<br /> <br>in children with IUGR and no catch-up growth.

Secondary Outcome Measures

Name	Time	Method
1. To assess the relation between 24-hour plasma GH profiles and the effect of GH therapy with two doses of GH;<br /><br>2. To assess the additional affects of GH therapy on glucose and lipid metabolism, blood pressure, procollagen-I and III, plasma IGF-I and IGF-binding protein 3 (IGFBP-3);<br /><br>3. Psychosocial functioning;<br /> <br>4. Intelligence.