Small for Gestational Age Infant
Conditions
Brief summary
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.
Interventions
BIOLOGICALSomatropin Injection low dose group
0.23mg/kg /wk，inject for seven divided doses
BIOLOGICALSomatropin Injection high dose group
0.46mg/kg /wk，inject for seven divided dose
Sponsors
Tongji Hospital
Beijing Children's Hospital
The First Affiliated Hospital with Nanjing Medical University
Shanghai Children's Hospital
The Children's Hospital of Zhejiang University School of Medicine
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
24 Months to 90 Months
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of small for gestational age, SGA. * Chronological age between 2-6.5 years in girls and 2-7.5 years in boys. Both genders. * Prepubertal stage (Tanner I). * Without catch-up growth in two years after birth. * Height was lower than the mean -2SD of the values of normal children of the same age and gender when participating in the study. * A GH peak concentration \>10µg/L in a provocative test within a year before participate in the study. * Bone age\<Chronological age+1. * Normal glucose regulation：Fasting blood-glucose \< 5.6mmol/L and 2-hour postprandial blood glucose\< 7.8mmol/L. * Gestational age≥Gestational age≥ 36weeks + 4days. * Never accepted growth hormone treatment. * The subjects and their guardians signed informed consent.
Exclusion criteria
* Subjects with Liver and renal insufficiency (ALT \> 2 times of upper limit of normal value, Cr\> upper limit of normal value). * Patients with positive for antibodies to hepatitis B core (anti-HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)。 * Known highly allergic constitution or allergic to the test drug. * Subjects with diabetes, severe cardiopulmonary and pulmonary disease, and hematological diseases, malignant tumors, or systemic infection, immunocompromised patients and patients with psychosis. * Subjects with other types of abnormal growth and development, such as Turner syndrome, constitutional delay of puberty, Laron syndrome, growth hormone receptor deficiency. * Subjects who have received the treatment of Somatropin or took part in other clinical trial study within 3 months. * Other conditions which in the opinion of the investigator preclude enrollment into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Height standard deviation score for chronological age (Ht SDSCA) | 26 weeks | HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PAH | 26 weeks， 52 weeks，78 weeks and 104 weeks | Change in prediction of adult height (PAH) |
| 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 | — |
| Change in mole ratio of IGF-1 and IGFBP-3 | 26 weeks， 52 weeks，78 weeks and 104 weeks | — |
| ΔHtSDSCA | 26 weeks， 52 weeks，78 weeks and 104 weeks | Change in height SDS for chronological age (Ht SDSCA) |
| Change in HV | 26 weeks， 52 weeks，78 weeks and 104 weeks | Change in annualized height velocity (HV) |
| Change in bone age maturation | 26 weeks， 52 weeks，78 weeks and 104 weeks | — |
Countries
China
Outcome results
None listed