A Trial to Evaluate the Correlation Between Spontaneous Catch-up Growth, Clinical Response to Sai… (NCT01067352) | Clinical Trial Compass
TerminatedPhase 3
A Trial to Evaluate the Correlation Between Spontaneous Catch-up Growth, Clinical Response to Saizen (Recombinant Human Growth Hormone, r-hGH) and Gene Expression Profiling in Children Small for Gestational Age (SGA)
Stopped: This study was discontinued prematurely due to difficulty in participant recruitment.
Italy25 participantsStarted 2004-02
Plain-language summary
This open, multicentric, randomized, controlled study is planned to evaluate the correlation between gene expression, spontaneous catch-up growth and therapeutic response to Saizen in SGA children.
Who can participate
Age range4 Years – 6 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* SGA at birth (defined as a length at birth equal or below the tenth percentile according to the Italian reference table of Bertini and Fabris)
* Age of 24 Months
* Caucasic
* Born at term (i.e. after the 37th completed week of gestation)
* Height equal or below (Group A) or up (Group B) the third percentile at the age of 24 months according to the Tanner reference table
* Sufficient GH secretion (more than 10 nanogram (ng)/milliliter (ml)) at least to one of the tests commonly used at that age (glucagon, Levo-dopa, arginine, clonidine, Growth Hormone Releasing Hormone (GHRH), GH integrated secretion)
* Normal level of Thyroid-stimulating hormone (THS), Free Triiodothyronine (FT3), Free Thyroxine (FT4), Insulin-like growth factor 1(IGF-1), insulin and haemoglobin A1c (HbA1c)
* Normal level of Immunoglobulin A (IgA)
* Children parents willing to comply with the protocol for the whole duration of the study
* A written Informed Consent before the baseline visit must be obtained from the parent(s) / legal guardian(s)
Exclusion Criteria:
* Congenital malformations (including Silver-Russel syndrome)
* Known abnormal karyotype, especially in girls
* Twins
* Severe psychomotor retardation
* Previous or ongoing treatment with anabolic steroids or r-hGH
* Treatments interfering with the immune system (including bacterial lysate)
* Severe chronic illnesses
* Autoimmune diseases
What they're measuring
1
Correlation Between Gene Expression Profiling and Catch-up Growth in Small for Gestational Age (SGA) Children