Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years (NCT00184691) | Clinical Trial Compass
CompletedPhase 3
Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years
Spain78 participantsStarted 1999-04
Plain-language 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 intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.
Who can participate
Age range2 Years ā 5 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 HernƔndez)
* 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 ā¦
What they're measuring
1
Effect on Efficacy: Height SDS for chronological age