Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tongji Hospital | OTHER |
| Beijing Children's Hospital | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Shanghai Children's Hospital |
Not provided
Not provided
Not provided
Not provided
To preliminary assess the efficacy and safety of recombinant human growth hormone injection on the treatment of small for gestational age (SGA), and determine the best dose.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatropin Injection low dose group | Experimental | 0.23mg/kg /wk,inject for seven divided doses. |
|
| Somatropin Injection high dose group | Experimental | 0.46mg/kg /wk,inject for seven divided doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin Injection low dose group | Biological | 0.23mg/kg /wk,inject for seven divided doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Height standard deviation score for chronological age (Ht SDSCA) | HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint) | 26 weeks |
| Height standard deviation score for chronological age (Ht SDSCA) | HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint) | 52 weeks |
| Height standard deviation score for chronological age (Ht SDSCA) | HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint) | 78 weeks |
| Height standard deviation score for chronological age (Ht SDSCA) | HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint) | 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ΔHtSDSCA | Change in height SDS for chronological age (Ht SDSCA) | 26 weeks, 52 weeks,78 weeks and 104 weeks |
| Change in HV | Change in annualized height velocity (HV) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xiaoping Luo | Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | China | |||
Not provided
| OTHER |
| The Children's Hospital of Zhejiang University School of Medicine | OTHER |
Not provided
Not provided
Not provided
Not provided
| Somatropin Injection high dose group | Biological | 0.46mg/kg /wk,inject for seven divided dose |
|
| 26 weeks, 52 weeks,78 weeks and 104 weeks |
| Change in bone age maturation | 26 weeks, 52 weeks,78 weeks and 104 weeks |
| Change in mole ratio of IGF-1 and IGFBP-3 | 26 weeks, 52 weeks,78 weeks and 104 weeks |
| Change in PAH | Change in prediction of adult height (PAH) | 26 weeks, 52 weeks,78 weeks and 104 weeks |
| Change in obesity prevalence | 26 weeks, 52 weeks,78 weeks and 104 weeks |
| Change in overweight | 26 weeks, 52 weeks,78 weeks and 104 weeks |
| The first affiliated Hospital with Nanjing Medical Universit |
| Nanjing |
| Jiangsu |
| China |
| Children's Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Beijing Children's Hospital of Capital Medical University | Beijing | China |
| Shanghai Children's Hospital | Shanghai | China |
| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003710 | Demography |
| D011154 | Population Characteristics |
Not provided
Not provided