About this trial
This study will take place at multiple sites and is divided into three phases:an initial 4-week getting-to-know-you phase,a 26-week main phase where participants receive medication,and a 4-week follow-up phase.Participants will be divided into three groups:two will receive different doses of PEG-rhGH Injection,and the third will receive hGH Injection.The goal is to determine which medication works best.
Eligibility criteria
Qualifiers
Born full-term and "small-for-dates" - Born at 37-41 weeks (full-term). - Birth weight below the 10th percentile for that week of pregnancy and sex .
At least 3 years old on the day the parent signs the consent form.
Still prepubertal (Tanner stage I - no signs of puberty yet).
Height at the first study visit is more than 2 standard deviations below the average for his or her age and sex.
Disqualifiers
Severe allergy to growth hormone or its ingredients.
Growth-hormone deficiency.
Any chromosome/genetic/syndrome cause of short stature.
Other diseases that can impair growth.
Trial design
Treatments tested in this trial
- PEG-rhGH Injection
- hGH Injection