dysmaturity small for gestational age
Conditions
Sponsors
Stichting Kind en Groei
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: - Children born with a birth length and/or weight
Exclusion criteria
Exclusion criteria: - Syndromes (except for Silver Russell Syndrome), chromosomal abnormalities and serious dysmorphic symptoms suggestive for a syndrome that has not yet been described. - severe psychomotor retardation according to DSM IV. - Complicated neonatal period. - Celiac disease and other chronic or serious diseases of the gastro-intestinal tract, heart, genito-urinary tract, liver, lungs, skeleton or central nervous system, or chronic or recurrent major infectious diseases, nutritional and/or vitamin deficiencies. - Any endocrine or metabolic disorder, except for growth hormone deficiency (GHD). - Genetic alterations in the IGF-I receptor gene. - Medications or interventions during the previous 6 months that might have interfered with growth. - Use of medication that might interfere with growth during growth hormone therapy. - Active or treated malignancy or increased risk of leukaemia. - Serious suspicion of psychosocial dwarfism (emotional deprivation). - Expected non-compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of individual growth hormone therapy compared to standard treatment with 1 mg/m2/day, assessment of long-term safety and psychosocial development. | — |
Secondary
| Measure | Time frame |
|---|---|
| n.a. | — |
Countries
Netherlands
Outcome results
None listed