Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years
Status and phase
Completed
Phase 3
Conditions
Small for Gestational Age
Foetal Growth Problem
Treatments
Drug: somatropin
Details and patient eligibility
About
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.
Enrollment
78 patients
Sex
All
Ages
2 to 5 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
Trial contacts and locations
13
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Data sourced from clinicaltrials.gov
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