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| Name | Class |
|---|---|
| Children's Hospital of Fudan University | OTHER |
| Huazhong University of Science and Technology | OTHER |
| Beijing Children's Hospital | OTHER |
| Peking University First Hospital |
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To evaluate the effectiveness of rhGH (Recombinant human growth hormone) injection for improving motor development in patients with PWS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhGH injection/Jintropin AQ | Experimental | Drug: Recombinant Human Growth Hormone Injection /Jintropin AQ, 30IU/10 mg/3ml/kit, 0.5 mg/m2/d for the first 4 weeks, then 1.0 mg/m2/d for subsequent 48 weeks; by subcutaneous injection, once per day for total 52 weeks.No control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Growth Hormone (rhGH) Injection | Drug | Drug: Recombinant Human Growth Hormone Injection /Jintropin AQ, 30IU/10 mg/3ml/kit, 0.5 mg/m2/d for the first 4 weeks, then 1.0 mg/m2/d for subsequent 48 weeks; by subcutaneous injection, once per day for total 52 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of the total motor quotient calculated by Peabody Developmental Motor Scale before and after treatment | Baseline, 26 weeks, 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gross motor quotient and fine motor quotient calculated by Peabody Developmental Motor Scale before and after treatment | Baseline, 26 weeks, 52 weeks | |
| Change of height standard deviation score (SDS) by chronological age before and after treatment | Baseline, 4 weeks, 13 weeks, 26 weeks, 39 weeks, 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohua Feng | Contact | 0431-85170552 | fengxiaohua@gensci-china.com |
| Name | Affiliation | Role |
|---|---|---|
| Feihong Luo, Doctor | Children's Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji medical college huazhong university of science & technology | Recruiting | Wuhan | Hubei | China | ||
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| OTHER |
| Peking Union Medical College Hospital | OTHER |
| The Children's Hospital of Zhejiang University School of Medicine | OTHER |
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| Body weight change before and after treatment | Baseline, 4 weeks, 13 weeks, 26 weeks, 39 weeks, 52 weeks |
| Change of BMI (Body mass index) standard deviation score before and after treatment | Baseline, 4 weeks, 13 weeks, 26 weeks, 39 weeks, 52 weeks |
| Global quotient, locomotor quotient, personal-social development quotient, language quotient, eye and hand coordination quotient, performance quotient and practical reasoning change calculated by Griffiths Mental Development Scale | Baseline, 26 weeks, 52 weeks |
| Bone maturation ( bone age/ chronological age: BA/CA) | Baseline, 52 weeks |
| Change of IGF-1(Insulin-like growth factor 1) SDS | Baseline, 4 weeks, 13 weeks, 26 weeks, 39 weeks, 52 weeks |
| IGF-1/IGFBP-3 molar ratio | Baseline, 4 weeks, 13 weeks, 26 weeks, 39 weeks, 52 weeks |
| The Children's Hospital,Zhejiang University School of Medicine |
| Recruiting |
| Hangzhou |
| Zhejiang |
| China |
| Beijing Children's Hospital, Capital Medical University | Recruiting | Beijing | China |
| Peking union medical college hospital | Recruiting | Beijing | China |
| Peking university first hospital | Recruiting | Beijing | China |
| Children's Hospital of Fudan University | Recruiting | Shanghai | China |
| ID | Term |
|---|---|
| D011218 | Prader-Willi Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D000096803 | Imprinting Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| 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 |
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