Recombinant human growth hormone in short children born small for gestational age. German Study Group.

The effects of recombinant human growth hormone (rhGH) treatment in 69 prepubertal, non-GH deficient children born small for gestational age (SGA) were evaluated over 2 years. At start of the study mean age was 5.1 years, mean bone age was 3.8 years and mean height SDS was -4.0. The children were randomly allocated to 3 groups receiving no treatment or daily subcutaneous injections of rhGH at a dose of 0.1 IU/kg body weight (group 0.1 IU) or 0.2 IU/kg body weight (group 0.2 IU). At start of the study mean height velocity SDS was -1.4 in the control group, -0.7 in group 0.1 IU and -1.4 in group 0.2 IU. After 2 years there was a significant increase in height velocity SDS in children treated with rhGH as compared to untreated children. Mean height velocity SDS after the first year of treatment was -1.2 in the control group, 2.8 in group 0.1 IU and 5.5 in group 0.2 IU. Corresponding values during the second year were -0.9, 1.6 and 2.9. A statistically significant difference was observed between the groups receiving 0.1 IU/kg/day and 0.2 IU/kg/day during the first year of treatment, whereas no difference between the treatment groups was found during the second year. Catch-up growth, i.e. a height velocity 1 SD above the mean, was achieved for 86% of group 0.1 IU and 95% of group 0.2 IU during the first year of treatment and was maintained for 65% and 79% of the patients in group 0.1 IU and 0.2 IU respectively in the second year. GH treatment was associated with a distinct acceleration of bone age. Tolerance of treatment was good. No clear trends were seen in any of the laboratory variables. In conclusion, this study shows that daily rhGH given at a dose of 0.1-0.2 IU/kg/day for 24 months is an effective and safe therapy to increase linear growth and induce catch-up growth in short SGA children.