Growth hormone deficiency, rapid progression of puberty with short stature, idiopathic short stature
Conditions
Interventions
Group1:Growth Hormone Deficiency,GHD:None
Group2 :Early Fast progressing Puberty,EFP:None
Group3:Idiopathic Short Stature, ISS:None
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 10 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. The patient's parents or legal guardians must read, understand, and sign the informed consent form, 2. Patients with reading ability must read (or be read to them by others) and sign the informed consent form for children; 3. Children with short stature aged 2 years and above; 4. Height below the 3rd percentile (-1.88 SD) of normal healthy children of the same age and gender; 5. PEG-rhGH or rhGH is required and belongs to one of the following indications: Cohort 1: Growth Hormone Deficiency (GHD) Cohort 2: Early Fast Progressing Puberty (EFP) Cohort 3: Idiopathic Short Stature (ISS) The GHD team is included in the group standard 1. Children aged 2-10 years old and pre-puberty; 2.Height lagging behind the 3rd percentile of the height of normal healthy children of the same age and gender [minus 1.88 standard deviations (-1.88s)], or minus 2 standard deviations (-2SD) or below; 3.Annual growth rate 1ml or multiple follicles with a diameter of >=4mm were visible in the ovaries; Boys' testicular volume >= 4 ml (testicular volume = length × width × thickness×0.71) or testicular length and diameter > 2.5cm; 4.The peak LH >= 5.0 U/L in the GnRH excitation test, and the ratio of LH peak to FSH peak >=0.6; 5.Individuals of the same race, gender and age are 2 standard deviations below the average height of the normal population or below the 3rd percentile in similar living environments. The ISS team is included in the group criteria 1.Height below -2 standard deviations (-2 SD) of the normal reference value or the 3rd percentile (-1.88 SD) for the same ethnicity, gender, and age; 2.Normal birth length and weight, no history of birth asphyxia, with proportionate body; 3.Normal or delayed bone age; 4.Height growth rate less than 5 cm/year; 5.Peak value of two GH stimulation tests >10 µg/L; 6.Exclude known causes of short stature (such as inflammatory bowel disease, juvenile chronic arthritis, growth hormone deficiency or resistance, hypothyroidism, Cushing's syndrome, and skeletal development abnormalities, etc.). No chronic organic disease, no psychological disorders or severe emotional disturbances, normal eating.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1.Participants meeting any of the following conditions shall be excluded from this study: 2.Patients whose growth plates have fully closed; 3.Patients for whom PEG-rhGH or rhGH treatment is expected to last less than 1 year; 4.Patients with potential tumors showing any signs of progression or patients with confirmed tumors; 5.Individuals allergic to growth hormone or its stabilizers; 6.Patients who have received any other growth hormone treatment besides the study drug within 6 months prior to screening; 7.Patients unable to provide complete medical records or are expected to be unable to complete follow-up or provide complete medical records; 8.Patients with other types of growth and development disorders, such as Turner syndrome, Laron syndrome, or growth hormone receptor deficiency; 9.Any other situations deemed inappropriate for inclusion by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Height (Ht);Weight (KG);Growth velocity (GV);Bone age (BA) [GP method];Height standard deviation score (HtSDS-CA, HtSDS-BA);IGF-1; IGFBP-3;IGF-1/IGFBP-3 molar ratio; | — |
Countries
China
Contacts
Public ContactYing Wei
Tianjin Medical University General Hospital
Outcome results
None listed