Short stature syndrome,small for gestational age
Conditions
Interventions
rhGH group:rhGH therapy for SGA infants
PEG-rhGH group:PEG-rhGH therapy for SGA infants
Sponsors
The Seventh Medical Center of the General Hospital of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
3 Years to 7 Years
Inclusion criteria
Inclusion criteria: 1. Girls aged 3-6 years old and boys aged 3-7 years old; 2. The subject meets the clinical diagnosis of a small for gestational age infant. Small for gestational age infants: infants whose birth weight is below the 10th percentile of the average birth weight of infants of the same gestational age (refer to the reference table for birth weight percentiles of newborns of different gestational ages in China; birth weight is based on the data on the birth certificate, and a copy is kept as a diagnostic certificate); 3. Failure to achieve catch-up growth: Children whose height is below the reference value of -2SD (including -2SD) or the 3rd percentile (-1.88SD) for normal children of the same age and gender, or children whose predicted adult height is severely impaired (deviating from genetic height by -2SD); 4. Pre adolescence (Tanner I stage); 5. Individuals with normal thyroid function or those who have undergone replacement therapy to maintain normal function; 6. Have not received rhGH treatment in the past; 7. Provide an informed consent form signed and dated by the legal guardian of the subject.
Exclusion criteria
Exclusion criteria: 1.Known or suspected hypersensitivity reactions to research intervention products or related products. 2.Individuals with abnormal liver and kidney function (ALT>upper limit of normal); Cr>upper limit of normal value); 3. Have a history of hepatitis B or hepatitis C or have known active hepatitis B or hepatitis C (this exclusion standard does not include the presence of antibodies due to hepatitis B vaccination). 4. Current or previously diagnosed malignant tumor patients; 5. Diagnosed with other types of growth and development abnormalities, such as Turner syndrome, Noonan syndrome, Laron syndrome, growth hormone receptor deficiency, growth retardation caused by hypothyroidism, etc. Women with height = 15 degrees, or moderate to severe scoliosis requiring treatment), claudication; 7.People diagnosed with diabetes, or laboratory examination/screening during screening - fasting blood glucose >=126mg/dL (7.0mmol/L) or - glycosylated hemoglobin (HbA1c) >= 6.5%; 8. Screening for individuals who have participated in any other clinical trials within the previous 3 months and have undergone drug or non drug interventions; 9. Researchers believe that other situations are not suitable for inclusion in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IGF1;height; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body composition;Neuropsychological development; | — |
Countries
China
Contacts
Public ContactFang He
The Seventh Medical Center of the General Hospital of the Chinese People's Liberation Army
Outcome results
None listed