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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
0.23mg/kg /wk,inject for seven divided doses
0.46mg/kg /wk,inject for seven divided dose
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
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
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 104 weeks
ΔHtSDSCA
Change in height SDS for chronological age (Ht SDSCA)
Time frame: 26 weeks, 52 weeks,78 weeks and 104 weeks
Change in HV
Change in annualized height velocity (HV)
Time frame: 26 weeks, 52 weeks,78 weeks and 104 weeks
Change in bone age maturation
Time frame: 26 weeks, 52 weeks,78 weeks and 104 weeks
Change in mole ratio of IGF-1 and IGFBP-3
Time frame: 26 weeks, 52 weeks,78 weeks and 104 weeks
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Shanghai Children's Hospital
Shanghai, China
Change in PAH
Change in prediction of adult height (PAH)
Time frame: 26 weeks, 52 weeks,78 weeks and 104 weeks
Change in obesity prevalence
Time frame: 26 weeks, 52 weeks,78 weeks and 104 weeks
Change in overweight
Time frame: 26 weeks, 52 weeks,78 weeks and 104 weeks