Efficacy and safety of growth hormone treatment in short children born small for gestational age (IUGR-3 STUDY); Effects of GH-levels on growth, insulin sensitivity and body composition.

Recruiting

Conditions: Small for Gestational Age (SGA), Kinderen met persisterend korte gestalte

Registration Number: NL-OMON24733

Lead Sponsor: Erasmus Medical Center/ Sophia Children's HospitalPO Box 20603000 CB RotterdamThe NetherlandsTel: +31 10 463 63 63

Brief Summary: van Dijk M, Mulder P, Houdijk M, et al. High Serum Levels of Growth Hormone (GH) and IGF-I during High Dose Growth Hormone Treatment in Short Children Born Small for Gestational Age. J Clin Endocrinol Metab 2006

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 157

Inclusion Criteria

1. Children born with a birth length and/or weight < - 2 SD for gestational age (Usher McLean (22));
2. Neonatal period without signs of severe asphyxia (defined as Apgar score < 3 after 5 minutes), and no serious diseases such as long-term artificial ventilation and oxygen supply, broncho pulmonary dysplasia or other chronic lung disease;
3. Short stature defined as a height SD score below –2.5 according to the Dutch National Growth References of 1997;
4. Height velocity (cm/year) for chronological age £ P50 (25);
5. Chronological age at start of treatment: 3.00 - 7.99 years (boys and girls);
6. Prepubertal signs defined as Tanner stage 1 or testicular volume < 4 ml (26);
7. Well documented growth data from birth up to 2 years and at least 1 year before the start of the study;
8. Both growth hormone deficient and growth hormone insufficient patients;
9. Informed consent.

Exclusion Criteria

1. Chromosomal disorders, known syndromes and serious dysmorphic symptoms suggestive for a syndrome that has not yet been described, except for Silver Russell Syndrome;
2. Coeliac disease and other chronic or serious diseases of the gastrointestinal tract, heart, genito-urinary tract, liver, lungs, skeleton or central nervous system, metabolic disease or chronic or recurrent major infectious diseases, nutritional and/or vitamin deficiencies;
3. Any endocrine or metabolic disorder such as diabetes mellitus, diabetes insipidus, hypothyroidism, or inborn errors of metabolism, except of GHD;
4. Use of medications or interventions at this moment or during the previous 6 months that might have interfered with growth, such as corticosteroids (including high dose of corticosteroid inhalation), sex steroids, growth hormone, or major surgery (particularly of the spine or extremities);
5. Active malignancy or increased risk of leukaemia;
6. Serious suspicion of psychosocial dwarfism (emotional deprivation);
7. Expected non-compliance.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To determine before, during and after stop of long-term growth hormone treatment:<br>a. Insulin sensitivity (via frequent sampling intravenous glucose tolerance test); <br>b. Body composition.<br>In relation with each other and with baseline serum GH levels during an overnight GH profile and in relation with 6 months of treatment with 2 different GH doses. <br>2. To assess the long-term efficacy of biosynthetic GH treatment in a dose of 3 IU\m2\day on final height and other various auxological parameters.

Secondary Outcome Measures

Name	Time	Method
To assess the safety of GH treatment by studying the short- and long-term effects on:<br>a. Blood pressure;<br>b. Thyroid function; <br>c. Fasting glucose and insulin andHbA1c levels.