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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Foetal Growth Problem, Small for Gestational Age

Intervention / Treatment
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* Drug: somatropin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: somatropin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on Efficacy: Height SDS for chronological age |  | after 48 months | 
| Safety: Bone maturation and glucose metabolism |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Height SDS for bone age; Height velocity SDS for bone age; Height velocity SDS for chronological age; Serum IGF-I and IGFBP-3 levels |  |  |