Status:
COMPLETED
Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Foetal Growth Problem
Small for Gestational Age
Eligibility:
All Genders
2-5 years
Phase:
PHASE3
Brief Summary
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 intrauterin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00184691
Start Date
April 1 1999
End Date
June 1 2005
Last Update
January 18 2017
Active Locations (13)
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1
Novo Nordisk Investigational Site
Barakaldo, Spain, 48903
2
Novo Nordisk Investigational Site
Barcelona, Spain, 08035
3
Novo Nordisk Investigational Site
Cadiz, Spain, 11009
4
Novo Nordisk Investigational Site
Córdoba, Spain, 14004