Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Hormones

Criteria

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