Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction
Phase 4
Completed
- Conditions
- Small for Gestational AgeFoetal Growth Problem
- Registration Number
- NCT00519844
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Tolerance of the treatment Compliance Biological (fasting glucose, fasting insulin, liver enzymes) Clinical (adverse events)