A Real World Study of the Effect of Early PEG-rhGH Therapy on Cognitive Development of SGA Infants

Inclusion Criteria:

1. Provide informed consent signed and dated by the subject's legal guardian;
2. The subjects met the clinical diagnosis of small for gestational age infants.
3. The age ranged from 6 months to 2 years old (including 6 months and 2 years old);
4. Height and head circumference are lower than the reference value - 2sd (including-2sd), whose weight is lower than the 10th percentile of the reference valueof normal children of the same age and sex;
5. The total developmental quotient GQ calculated according to Griffiths mentaldevelopment scale is less than 100 points (100 points) Indicates that thedevelopmental age is consistent with the physiological age);
6. Birth gestational age ≥ 37 weeks and < 42 weeks, single birth and non test tube baby;
7. Symmetrical SGA: birth weight index > 2.0 (gestational age = 37 weeks), or > 2.2 (gestational age > 37 weeks) . Weight index [birth weight (g) × 100 / birth length (CM) ];
8. Normal thyroid function or normal after replacement therapy;
9. No previous rhGH treatment

Exclusion Criteria:

1. Patients with abnormal liver and kidney function (ALT > 2 times the upper limit ofnormal value, Cr > the upper limit of normal value);
2. Severe familial dwarfism (father height < 155cm or mother height < 145cm);
3. Definite neurological defects and / or severe neurodevelopmental retardation (thetotal development quotient calculated according to Griffiths mental development scaleis less than 70), definite syndrome affecting cognitive development; Severe perinatalcomplications (such as severe asphyxia, sepsis, necrotizing enterocolitis, respiratorydistress syndrome with long-term sequelae);
4. Genetic metabolic diseases (such as congenital hypothyroidism, phenylketonuria,methylmalonic acidemia);
5. Congenital skeletal dysplasia, or moderate or above scoliosis (or scoliosis ≥ 15 °)requiring treatment or claudication;
6. Short stature with other definite causes, such as osteochondral dysplasia and Turnersyndrome (TS), Noonan syndrome (NS), Prader Willi syndrome (PWS), Angelman syndrome (as), silver Russell syndrome (SRS), or other genetically confirmed syndromes (Note:diseases that meet the clinical diagnostic criteria adopt the method of clinicaldiagnosis; when the clinical diagnosis is difficult to be clear, or the diagnosis ofthe disease depends on gene screening, the method of gene diagnosis shall besupplemented / adopted);
7. patients with diabetes or fasting blood glucose are abnormal and the researchersbelieve that they may affect the safety of subjects.
8. Continuous application of other hormone therapy or systemic glucocorticoid therapy formore than one month in the past 6 months (local or inhaled glucocorticoids areallowed);
9. Patients with a history of convulsions or epilepsy, except for the relief or recoveryof convulsions or epilepsy symptoms after the release of definite causes (such as highfever, calcium deficiency, brain infection, etc.);
10. Patients with other systemic chronic diseases;
11. Patients with confirmed tumors, or patients with family history of tumors (two or moretumor patients within three generations of immediate relatives), previous tumorhistory or considered as patients with high risk of tumors in combination with otherinformation, clear syndromes with high risk of tumors (such as Bloom syndrome, Fanconisyndrome, Down syndrome, etc.);
12. Known high allergic constitution or allergic to the test drug in this study;
13. Those who have participated in clinical trials of other drugs within 3 months (theplacebo group is not subject to this restriction);
14. Have received drug treatment that may interfere with GH secretion or GH effect within 3 months (including but not limited to any type of recombinant human growth hormoneand protein assimilation drugs (including but not limited to oxandron, danazol andstanazol) other than rhGH injection);
15. The investigator considers that it is not suitable to be selected for this clinicaltrial.