Conditions: Growth Disorders Intrauterine Growth Retardation
Keywords: Short height intra-uterine growth retardation Genotonorm continuous treatment intermittent treatment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 208
Healthy volunteers: no

Brief summary:
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation

Detailed description:

Arms:
arm 1: Continuous 0.7 IU/kg/week or 0.03 mg/kg/day arm 2: Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day arm 3: Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day

Interventions: intervention 1: Genotonorm intervention 2: Genotonorm intervention 3: Genotonorm
Intervention descriptions: intervention 1: 0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection intervention 2: 1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection intervention 3: 1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)

Protocol document: