Context: Growth hormone treatment is effective in children born SGA; however, its effectiveness and safety in very young SGA children is unknown.

Objective: The aim was to analyze the outcome of very young SGA children treated with GH and followed for 2 years. The results after 24 months of treatment, compared with a control group without treatment during 12 months followed by 12 months of treatment, are shown.

Design: We performed a multi-center, controlled, randomized, open trial.

Settings: The Pediatric Endocrinology departments of 14 public hospitals in Spain participated in the study.

Patients: Seventy-six children, aged 2-5 years born SGA and without catch-up growth, were studied.

Intervention: Children received GH at 0.06 mg/kg/day for 2 years (group I) or were followed for 12 months with no treatment and then treated for 12 months (group II).

Main Outcome Measures: Age, general health status, pubertal stage, bone age, height, weight, biochemical and hormonal analyses, and adverse side-effects were determined at biannual check-ups.

Results: The mean height SDS gain for chronological age in children treated for 24 months (group I) was 2.10 SDS, while in those treated only during the last 12 months (group II) was 1.43 SDS. In both groups, children under 4 years of age had the greatest gain in growth velocity. No significant acceleration of bone age or side-effects related to treatment was seen.

Conclusion: Very young SGA children without spontaneous catch-up growth could benefit from GH treatment as growth was accelerated and no negative side-effects were observed.