Idiopathic Short Stature
Conditions
Interventions
Case series:None
Sponsors
Children's Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 16 Years
Inclusion criteria
Inclusion criteria: (1) Clinically diagnosed patients with idiopathic short stature: 1) Height = average height of normal children of the same race, age and sex -2.0SDS or <P3 level; 2) Normal height and weight at birth, no history of asphyxia rescue, and symmetrical body; 3) except for diseases known to cause short stature (such as enteropathy, JIA, GHD or growth hormone resistance, hypothyroidism, Cushing's syndrome, and skeletal dysplasia); 4) No psychological and serious emotional disorders, normal diet; The growth velocity (GV) is slightly slow or normal, with a general growth rate of 5-7cm/ year (at least observed in 3 months); 5) Thyroid function, adrenal function, liver and kidney function, MRI of pituitary gland, long bone slices of limbs, and chromosome examination were normal; 6) The peak GH values of the two standard growth hormone stimulation tests were =10mg/ml, and the concentration of IGF-1 was normal or slightly lower; (2) Patients who have not received rhGH drugs in the past 2 years; (3) Children with no contraindications for PEG-rhGH as assessed by their physician; (4) The patient or the guardian voluntarily signs the informed consent
Exclusion criteria
Exclusion criteria: (1) Liver and renal insufficiency (ALT > 2 times the upper limit of normal, Cr > the upper limit of normal); (2) patients with active hepatitis B; (3) Patients with serious heart and lung, blood system, malignant tumors, diabetes and other diseases or systemic infections, and patients with low immune function; (4) Diagnosed with other types of growth and development abnormalities, such as growth hormone deficiency, polypituitary hormone deficiency, Turner syndrome, Noonan syndrome, Laron syndrome, growth hormone receptor deficiency, small for gestational age infants with short stature, growth and development delays due to malnutrition, growth and development delays due to thyroid underfunction, etc. Chromosomal abnormalities were not excluded in girls with backward growth. (5) Children with microcephaly or with mental or developmental retardation or with abnormal skeletal development or with other congenital malformations; (6) The height increase of 3 months in late adolescence was <0.5cm; (7) People who are known to be highly allergic or allergic to the drugs tested in this study; (8) Participants who have participated in other growth and development-related drug clinical trials within 3 months; Or other conditions in which the investigator considers the patient unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year and 2 years after treatment, changes in height SDS and height SDS of subjects; | — |
Secondary
| Measure | Time frame |
|---|---|
| Height standard deviation integral change before and after treatment (?HtSDSCA);Height standard deviation integral change by bone age before and after treatment (?HtSDSBA);;Incidence of adverse events and serious adverse events after treatment; | — |
Countries
China
Contacts
Public ContactZHU GAOHUI
Children's Hospital of Chongqing Medical University
Outcome results
None listed