Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years

Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone Which Will be Started Randomly at the Ages of 2 to 5, in Children Diagnosed of IUGR

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.

Inclusion Criteria:

• IUGR defined as birth length and/or weight below the lower limit (< P10) of the Lubchenco curves for the gestational age.
• Chronological age = 2-5 years
• HV below average for CA
• Insufficient catch-up growth (Height < P3 for chronological age, according to Hernández)
• Parental height greater than or equal to -2 SDS of average, that is, 160 cm or more for the father and 148 cm or more for the mother
• Normal response to GH stimulation test (greater tan or equal to 10 ng/mL)
• Bone age (measured through Greulich and Pyle method) less than or equal to CA

Exclusion Criteria:

• Children born from multiple pregnancy
• Children with post-ischemic encephalopathy
• Recorded malformative syndromes associated to short stature (Silver-Russell, Rubinstein Taybi, Seckel etc.)
• Any metabolic or endocrinological disorder (diabetes mellitus, diabetes insipidus, congenital metabolic disorders, with the exception of thyroid diseases corrected by replacement therapy)
• Any type of growth retardation associated to infections, embryopathies or severe chronic diseases (hemopathies, hepatopathies, malabsorptive pathology, neurologic alterations....)
• Nutritional disorders (celiac disease) or osteodystrophies
• Patients who receive or received any treatment (anabolic drugs, sex steroids, etc.) likely to interfere with GH effects
• Abnormal karyotype
• Neoplasms
• Previous or ongoing chemotherapy and/or irradiation
• Renal dysfunction, defined as serum creatinine > 1 mg/dL