Small for Gestational Age with persistent short stature
Conditions
Interventions
Growth hormone treatment.
Sponsors
Prof. dr. A.C.S. Hokken-Koelega
Erasmus MC Sophia
Room number SP-3437
Dr. Molewaterplein 60
3015 GJ Rotterdam
a.hokken@erasmusmc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 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); 3. No catch-up growth defined as obtaining a height of ³ P3 within the first 2 years of life or at a later stage; 4. Height velocity (cm/year) for chronological age £ P50; 5. Chronological age at the start of treatment: 3.00 - 7.99 years (boys and girls); 6. Prepubertal signs defined as Tanner stage 1 or testicular volume < 4 ml; 7. Well documented growth data from birth up to 2 years and at least 1 year before the start of the study.
Exclusion criteria
Exclusion criteria: 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; 3. Chromosomal abnormalities or signs of a syndrome, except of Silver-Russell Syndrome (SRS); 4. Chondrodysplasia; 5. Hydrocephalus; 6. Active malignancy or increased risk of leukaemia; 7. Serious suspicion of psychosocial dwarfism (emotional deprivation); 8. Previous anabolic sex steroid or GH therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of biosynthetic GH treatment on various auxological parameters and bone maturation in comparison with a randomized untreated control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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; 2. To assess the long term efficacy of biosynthetic GH treatment on final height and other various auxological parameters; 3. To assess the safety of GH treatment by studying the short- and long-term effects on blood pressure, carbohydrate metabolism, thyroid function. | — |
Contacts
Public ContactP.E. Breukhoven
Erasmus Medical Center Sophia Children's Hospital Room number SP-3435 P.O. Box 2060
Outcome results
None listed