title: 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.
abstract: BACKGROUND
  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.
  
  
  METHODS
  We performed a multicenter, controlled, randomized, open trial.
  
  
  METHODS
  The pediatric endocrinology departments of 14 public hospitals in Spain participated in the study.
  
  
  METHODS
  Seventy-six children, aged 2-5 yr born SGA and without catch-up growth, were studied.
  
  
  METHODS
  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).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Endocrinology, Hospital Infantil Universitario Niño Jesús, Avenida Menéndez Pelayo, 65 E28009 Madrid, Spain. argentefen@terra.es
authors.forename: Jesús
authors.initials: J
authors.lastname: Argente
authors.forename: Ricardo
authors.initials: R
authors.lastname: Gracia
authors.forename: Lourdes
authors.initials: L
authors.lastname: Ibáñez
authors.forename: Antonio
authors.initials: A
authors.lastname: Oliver
authors.forename: Emilio
authors.initials: E
authors.lastname: Borrajo
authors.forename: Amaya
authors.initials: A
authors.lastname: Vela
authors.forename: Juan Pedro
authors.initials: JP
authors.lastname: López-Siguero
authors.forename: M Llanos
authors.initials: ML
authors.lastname: Moreno
authors.forename: Francisco
authors.initials: F
authors.lastname: Rodríguez-Hierro
mesh_terms: D000365:Age Determination by Skeleton; D000886:Anthropometry; D001827:Body Height / Q000187:drug effects; D015992:Body Mass Index; D002675:Child, Preschool; D005260:Female; D006128:Growth / Q000187:drug effects*; D013006:Growth Hormone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007231:Infant, Newborn; D007236:Infant, Small for Gestational Age / Q000254:growth & development*; D018972:Insulin-Like Growth Factor Binding Protein 3 / Q000378:metabolism; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D008297:Male; D010290:Parents
chemical_list: D018972:Insulin-Like Growth Factor Binding Protein 3; D007334:Insulin-Like Growth Factor I; D013006:Growth Hormone