Clinical trial: Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat SGA Children With Short Stature (NCT02375620)

Eligibility criteria:
Inclusion Criteria:

          -  The patients are diagnosed as being clinically full term small for gestational age
             infant.

          -  Girl are 3-6 years old, boys are 3-7 years old.

          -  Be in preadolescence (Tanner stage 1).

          -  The child did not achieve catch-up growth when he/she entered the group (the
             definition of catch-up growth is that the height is higher the third percentile with
             the same age and gender) (Appendix 2 and 3).

          -  The height of child is shorter than -2SDS of the median of normal children with the
             same age and gender when he/she entered the group (the mean height and height standard
             deviation of normal children with the same age and gender of normal children regard
             the height data in the physical development investigation data of children aged 0-18
             in 9 cities of China (2005) as standard [13], Appendix 4 and 5).

          -  Within a year before entering the group, after any growth hormone stimulation test,
             the peak concentration of growth hormone in serum>10 µg/L.

          -  Bone age≤ the actual age+1.

          -  The function of glucose regulation is normal: fasting blood glucose < 5.6mmol/L.

          -  Birth gestational age ≥ 37 weeks.

          -  The subjects and their guardians sign the informed consent (if the subjects is lack of
             ability for signing the informed consent, his legal guardian can write the subjects
             name instead).

        Exclusion Criteria:

          -  People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal
             value, Cr> the upper limit of normal value).

          -  Patients are positive for hepatitis B core antigen (HBc), hepatitis B surface antigen
             (HBsAg) or hepatitis B e antigen (HBeAg).

          -  People with known highly allergic constitution or allergy to the drug or the excipient
             of the study.

          -  People with diabetes, severe cardiopulmonary, hematological system and malignant
             tumors diseases or general infection, immune deficiency and patients with mental
             disease.

          -  Other abnormal growth and development, such as Turner syndrome, Laron syndrome, growth
             hormone receptor deficiency.

          -  Potential tumor patients (family history).

          -  Patients who used growth hormone for treatment.

          -  Subjects took part in other clinical trial study within 3 months.

          -  Patients used other hormonal for treatment within 3 months (such as sex hormone,
             glucocorticoid and etc., treat for more than a month) and received the drug treatment
             which may interfere with the secretion of GH or GH function (oxandrolone, growth
             hormone releasing hormone and etc.);

          -  Other conditions which in the opinion of the investigator preclude enrollment into the
             study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 7 Years

Patient description (medical language): A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively.  On physical examination, the patient's height is in the 5th percentile of her age.  Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus.  Chromosomal analysis reveals a 45, XO karyotype.

Patient description (patient's own words): I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype.

Does the patient match the trial criteria? Contradiction