NL-OMON26748
Completed
Not Applicable
Growth Hormone Treatment of Children after Intrauterine Growth Retardation (IUGR-1 study).
ovo Nordisk A/S, Denmark0 sites90 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- 1. Small for gestational age (SGA)
- Sponsor
- ovo Nordisk A/S, Denmark
- Enrollment
- 90
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
- 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;
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;
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;
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;
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;
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;
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;
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;
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;
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.
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Not specified
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