Foetal Growth Problem, Small for Gestational Age
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment.
Interventions
DRUGsomatropin
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Children treated for 3 years with Maxomat® because of small for gestational age * Postnatal growth failure by the age of 3 years or more * No associated growth hormone deficiency * Height growth velocity greater than 2 cm/yr over the 12 month period preceding the inclusion * Bone age no more than 13 years for girls and no more than 15 years for boys
Exclusion criteria
* Known, evolving tumour * Hypertrophic cardiomyopathy * Hypertension not controlled on maximum therapy * Benign intracranial hypertension * Known glucose intolerance or known diabetes mellitus * Acute or active chronic hepatitis * Chronic renal failure * Chromosomal and/or genetic syndromes (other than Silver-Russell syndrome) or abnormality
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Satisfaction/preference with the method of treatment assesses by means of a satisfaction questionnaire and a standard questionnaire of preference | after 3 months of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Clinical (adverse events) | — |
| Biological (fasting glucose, fasting insulin, liver enzymes) | — |
| Tolerance of the treatment | — |
| Compliance | — |
Countries
France
Outcome results
None listed