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Improvement in Growth after Two Years of Growth Hormone Therapy in Very Young Children Born Small for Gestational Age and without Spontaneous Catch-Up Growth: Results of a Multicenter, Controlled, Randomized, Open Clinical Trial

Hospital Infantil Universitario Niño Jesús (J.A.), Universidad Autónoma de Madrid and CIBER Fisiopatología Obesidad y Nutrición (CB06/03) Instituto de Salud Carlos III, 28009 Madrid, Spain; Hospital Infantil Universitario La Paz (R.G., A.O.), 28034 Madrid, Spain; Endocrinology Unit (L.I., F.R.-H.), Hospital Sant Joan de Déu, University of Barcelona, 08950 Esplugues, Barcelona, Spain; Department of Pediatrics (E.B.), Hospital Universitario Virgen de la Arrixaca, 30120 Murcia, Spain; Department of Paediatric Endocrinology (A.V.), Hospital de Cruces, 48903 Barakaldo, Spain; Department of Pediatrics (J.P.L.-S.), Hospital Materno Infantil de Málaga, 29011 Málaga, Spain; and Novo Nordisk Pharma S.A. (M.L.M.), 28033 Madrid, Spain

Address all correspondence and requests for reprints to: Jesús Argente, M.D., Ph.D., Professor and Chairman, Department of Endocrinology Hospital Infantil Universitario Niño Jesús, Avenida Menéndez Pelayo, 65 E28009 Madrid, Spain. E-mail: argentefen{at}terra.es.

Context: GH treatment is effective in children born small for gestational age (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 yr. 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 multicenter, 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 yr born SGA and without catch-up growth, were studied.

Intervention: Children received GH at 0.06 mg/kg·d for 2 yr (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 SD score gain for chronological age in children treated for 24 months (group I) was 2.10, whereas in those treated only during the last 12 months (group II) was 1.43. In both groups, children under 4 yr 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 because growth was accelerated and no negative side effects were observed.