This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).
Who can participate
Age range4 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:
* Pre-pubertal (Tanner stage I) children born SGA Boys: 4 years of age or older Girls: 4 years of age or older
* Growth disturbance defined as current height SDS \< -2.5 (and parental adjusted SDS \<-1) for chronological age and sex according to country specific references.
* Birth weight and/or length below -2 standard deviations (SD) for gestational age
Exclusion Criteria:
* Onset of puberty
* Closed epiphyses
* Diabetes mellitus type I or type II
* Fasting blood glucose greater than 100 mg/dl or greater than 5.6 mmol/l measured in venous blood sample
* Abnormal findings in Oral Glucose Tolerance Test (OGTT) defined by greater than 140 mg/dl or greater than 7.8 mmol/l after 120 minutes
* Known IGF-I level above +2SD for sex and age
* Acute critical illness
* Previous treatment with any hGH preparation
* Treatment with antidiabetic medication (e.g. metformin, insulin)
* Drug abuse, substance abuse, or alcohol abuse
What they're measuring
1
Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment
Timeframe: throughout the study, approximately 13 years