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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.

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Date

2007-08

Authors

Argente, Jesús
Gracia, Ricardo
Ibáñez, Lourdes
Oliver, Antonio
Borrajo, Emilio
Vela, Amaya
López-Siguero, Juan Pedro
Moreno, M Llanos
Rodríguez-Hierro, Francisco

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Endocrine Society
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Abstract

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.

Description

Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't;

MeSH Terms

Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Physical Examination::Anthropometry
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Physical Examination::Body Constitution::Body Weights and Measures::Body Size::Body Height
Medical Subject Headings::Named Groups::Persons::Age Groups::Child::Child, Preschool
Medical Subject Headings::Check Tags::Female
Medical Subject Headings::Phenomena and Processes::Physiological Phenomena::Physiological Processes::Growth and Development::Growth
Medical Subject Headings::Chemicals and Drugs::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Peptide Hormones::Pituitary Hormones::Pituitary Hormones, Anterior::Growth Hormone
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Named Groups::Persons::Age Groups::Infant::Infant, Newborn
Medical Subject Headings::Named Groups::Persons::Age Groups::Infant::Infant, Newborn::Infant, Low Birth Weight::Infant, Small for Gestational Age
Medical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Carrier Proteins::Insulin-Like Growth Factor Binding Proteins::Insulin-Like Growth Factor Binding Protein 3
Medical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Intercellular Signaling Peptides and Proteins::Somatomedins::Insulin-Like Growth Factor I
Medical Subject Headings::Check Tags::Male
Medical Subject Headings::Named Groups::Persons::Parents
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Age Determination by Skeleton
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Physical Examination::Body Constitution::Body Weights and Measures::Body Mass Index

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Antropometría, Estatura, Determinación de la Edad por el Esqueleto, Índice de Masa Corporal, Preescolar, Femenino, Humanos, Recién Nacido, Crecimiento, Hormona del Crecimiento, Recién Nacido Pequeño para la Edad Gestacional, Proteína 3 de Unión a Factor de Crecimiento Similar a la Insulina, Factor I del Crecimiento Similar a la Insulina, Masculino, Padres

Citation

Argente J, Gracia R, Ibáñez L, Oliver A, Borrajo E, Vela A, et al. 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. J. Clin. Endocrinol. Metab.. 2007 Aug; 92(8):3095-101