Small for Gestational Age
Conditions
Interventions
Recombinant human growth hormone (rhGH) treatment group:None
polyethylene glycol recombinant human growth hormone (PEG-rhGH) treatment group:None
Sponsors
Children's Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
2 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Birth weight and/or length less than the 10th percentile of mean birth weight and/or length of the same gestational age. 2. Actual age between 2-6 years old at the time of enrollment. 3. At the time of participating in the study, the height is lower than the mean of normal children of the same age and sex -2SD, which meets the indications for growth hormone therapy. 4. Subjects and their guardians sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Abnormal liver and kidney function (ALT> 1.5 times the upper limit of normal, Cr > upper limit of normal). 2. Suffering from diabetes, severe cardiopulmonary disease, hematologic disease, digestive system, malignant tumor or systemic infection, immunocompromised and psychotic. Positive for hepatitis B core (HBc), hepatitis B surface antigen (HBsAg), or hepatitis B e antigen (HBeAg) antibodies. 3. Highly allergic constitution or allergy to the test drug. 4. Previous treatment with growth hormone. 5. Received treatment with other hormones (such as gonadal hormones and glucocorticoids, etc.) within 3 months, including oxandrolone, growth hormone-releasing hormone, etc. 6. Participate in other clinical studies within 3 months. 7. Other conditions that, in the opinion of the investigator, preclude participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?Ht SDSCA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ht SDS BA;growth velocity;IGF-1 SDS;IGF-1/IGFBP-3;bone maturation status;adverse event; | — |
Countries
China
Contacts
Public ContactJie Shao
Children's Hospital, Zhejiang University School of Medicine
Outcome results
None listed