Pediatric growth and development diseases
Conditions
Interventions
one:RhGH injection 0.5-1mg/m2/d, once a day, subcutaneous injection
two:PEG-rhGH injection 0.2mg/kg/week, once a week, subcutaneous injection
three:no treatment
Sponsors
Linyi People‘s Hospital
Eligibility
Sex/Gender
All
Age
0.5 Years to 2 Years
Inclusion criteria
Inclusion criteria: (1) Provide an informed consent form signed and dated by the legal guardian of the party involved; (2) The subjects meet the diagnosis of global development delay (GDD), which refers to developmental delay involving two or more aspects such as cognition, movement, and adaptive behavior. GDD is a common chronic neurodevelopmental disorder diagnosed under the age of 5; (3) The age range is from 6 months to 2 years old (including 6 months and 2 years old); (4) Birth gestational age >=37 weeks and<42 weeks, singleton and non test tube babies; (5) Infants not smaller than gestational age (SGA) (6) GESELL Total Developmental Quotient is less than 85 points (7) Normal thyroid function or normal after replacement therapy; (8) I have not received rhGH treatment before (9) Perform chromosome, gene and other related tests
Exclusion criteria
Exclusion criteria: (1) Patients with abnormal liver and kidney function (ALT>twice the upper limit of normal, Cr>upper limit of normal); Patients with systemic chronic diseases such as heart, liver, and kidney; (2) Severe familial dwarfism (father height= 15°) requiring treatment or claudication; (5) Neurodevelopmental and cognitive developmental disorders with other clear causes, such as osteochondral dysplasia, Turner syndrome (TS), Noonan syndrome (NS), Prader Willi syndrome (PWS), Angelman syndrome (AS), Silver Russell syndrome (SRS), etc; (6) Abnormal diabetes or fasting blood glucose patients, researchers believe that they may affect the safety of subjects; (7) Continuous use of other hormone therapy or systemic corticosteroid therapy for more than one month in the past 6 months (local or inhaled corticosteroids are allowed); (8) For patients with a history of seizures or epilepsy, the cause should be clearly identified after the symptoms of seizures or epilepsy have been relieved or restored (such as high fever, calcium deficiency, brain infection, etc.); Excluding patients with a history of seizures or epileptic seizures; (9) Patients with other systemic chronic diseases; (10) Diagnosed cancer patients, or patients with a family history of cancer (two or more cancer patients in three generations of direct relatives), patients with a history of cancer or considered high-risk for cancer based on other information, and patients with clear high-risk syndromes for cancer (such as Bloom syndrome, Fanconi syndrome, Down syndrome, etc.); (11) Known high allergy constitution or allergy to the test drug in this study; (12) People who have participated in clinical trials of other drugs within 3 months (placebo group is not subject to this restriction); (13) Received any type of drug therapy that may interfere with the secretion or action of growth hormone within 3 months (including but not limited to recombinant human growth hormone and protein assimilation drugs other than rhGH injection (including but not limited to Oxandrolone, Danazol, and Stanozeb); (14) The researchers believe that it is not suitable to be selected for this clinical trial; (15) During the follow-up process, parents interrupted treatment on their own or did not cooperate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| developmental quotient;gross motor function measure,GMFM;fine motor function measure,FMFM;Ages & Stages Questionnaires (ASQ); | — |
Countries
China
Contacts
Public ContactYongzhen Xue
Linyi People‘s Hospital
Outcome results
None listed