Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years
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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.
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Ages Eligible for Study:
2 Years to 5 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
Previous or ongoing chemotherapy and/or irradiation
Renal dysfunction, defined as serum creatinine > 1 mg/dL