This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months
1.2 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)
2.4 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)
Novo Nordisk Investigational Site
Paris, France
Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion
Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray
Pubertal development, assessed according to Tanner method
Height velocity
Final height
Number of Adverse Events
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