Prepubertal (Tanner Stage ?) term small for gestational age (SGA) children with short stature
Conditions
Interventions
Full-term SGA (small for gestational age) children 4-6 year old group.:None
Full-term SGA (small for gestational age) children 2-4 year old group.:None
Full-term SGA (small for gestational age) children over 6 years old group.:None
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Meet the clinical diagnosis of term(37 weeks = gestational age = 2 years,with height below 2 standard deviations (-2SD) of the mean height or beliw the 3rd percentile (P3) for chileren of teh same age, sex, and race. 3. Prepubertal (Tanner stage I). 4. No systemic disease, other endocrine diseases, nutritional problems or chromosomal abnormalities. 5. Parent(s)/guardian(s) agree to the patient's participation in this study and voluntarily sign the written informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Liver and kidney function abnormalities (ALT > 1.5 times the upper limit of normal, Cr > the upper limit of normal). 2. Those whose tests for HBcAb, HBsAg, HBeAg all show positive results. 3. Individuals with known highly allergic constitution,or those allergic to drugs or excipients. 4. Suffering from diseases such as diabetes, severe heart and lung disorders,blood system disorders, malignant tumors, or systemic infection, with low immunocompromised or and mental patients. 5. Other types of growth and developmental abnormalities, such as Turner syndrome, Laron syndrome, growth hormone receptor deficiency, etc. 6. Patients with a history of tumor or currently suffering from tumor or highly suspected potential tumor (such as combined with a significant family history). 7. Participants who have participated in other drug clinical trials within 3 months before signing the ICF. 8. Those who used other hormone therapy (e.g., sex hormones, glucocorticoids, etc., for more than a month) within months before signing the ICF and those who were treated with drugs that might interfere with growth hormone (GH) secretion or the action of GH (oxandrolone, growth-releasing hormone, etc.). 9. Any other conditions that the researcher considers unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?HtSDS; | — |
Secondary
| Measure | Time frame |
|---|---|
| cognitive development;weight;Body Mass Index;Safety and tolerability of PEG-rhGH treatment; | — |
Countries
China
Contacts
Public ContactKundi Wang
China-Japan Friendship Hospital
Outcome results
None listed