Small for Gestational Age (SGA), Kinderen met persisterend korte gestalte
Conditions
Interventions
Growth hormone treatment
Norditropin SimpleXx 15 mg/1.5 ml
The first 60 patients of five years and older who are included in the study, will undergo an overnight GH-profile, FSIGT and Dual Energy X-ray absorptiometry (DXA).
Sponsors
Erasmus Medical Center/ Sophia Children's Hospital
PO Box 2060
3000 CB Rotterdam
The Netherlands
Tel: +31 10 463 63 63
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine before, during and after stop of long-term growth hormone treatment: a. Insulin sensitivity (via frequent sampling intravenous glucose tolerance test); b. Body composition. 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. 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
| Measure | Time frame |
|---|---|
| To assess the safety of GH treatment by studying the short- and long-term effects on: a. Blood pressure; b. Thyroid function; c. Fasting glucose and insulin andHbA1c levels. | — |
Contacts
Public ContactS.W.K. Kort, de
Erasmus Medical Center, Sophia Children's Hospital, Room number SP-3435, P.O. Box 2060
Outcome results
None listed