Childhood short stature (with different genetic height backgrounds)
Conditions
Interventions
Cohort 1: Low genetic height group(MPH >= 160cm):None
Sponsors
The People's Hospital of Guang'an District, Guang'an City
Eligibility
Sex/Gender
All
Age
3 Years to 15 Years
Inclusion criteria
Inclusion criteria: 1.Children aged 3 years and above with short stature of different etiologies; 2.Height at enrollment below 2SD of the average height or 3rd percentile (P3, -1.88SD) for age, gender, and ethnicity; 3.Annual growth rate (HV) <=5cm/y; 4.Meeting PEG-rhGH indications; 5.No systemic, endocrine, nutritional, or chromosomal abnormalities; 6.Bone age: girls <=13 years, boys <=14 years; 7.Subjects and guardians voluntarily sign informed consent;
Exclusion criteria
Exclusion criteria: 1.Abnormal liver or kidney function; 2.Positive for hepatitis B virus; 3.Severe allergic constitution; 4.Systemic diseases or immunocompromised; 5.Confirmed tumor; 6.Psychiatric patients; 7.Other growth and development abnormalities; 8.Previous treatment with drugs interfering with GH secretion or action, or use of other hormones within 3 months; 9.Completely closed epiphyses; 10.Other conditions deemed unsuitable by researchers;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in height standard deviation score for chronological age (?HT SDS) before and after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoint analysis: All adverse events collected and monitored during the medication period are included in the analysis.;Changes in IGF-1 and IGFBP3 (from baseline to week 52);Bone Maturity;Annual growth velocity (HV) HV (cm/year) = 12 × (Height at the end of treatment - Height at the start of treatment) / Duration of treatment (months); | — |
Countries
China
Contacts
Public ContactChen Fang
The People's Hospital of Guang'an District, Guang'an City
Outcome results
None listed