UnknownNot Applicable

Genetic Diagnosis and Human Growth Hormone Treatment in Small for Gestational Age Children With Short Stature

150 participantsStarted 2021-10-11

Plain-language summary

This study is a multi-center, retrospective and non-interventional research. In this study, a total of 150 short children who were small for gestational age and had been treated with recombinant human growth hormone (rhGH) are selected for genetic testing. The aims of this study are to analyze the genetic etiology of SGA children with short stature, and to compare the efficacy and safety of rhGH treatment in subjects with different etiologies.

Who can participate

Age range2 Years – 20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Single birth, clinical diagnosis of SGA;
✓. rhGH treatment beginned before puberty (Tanner stage I), regardless of gender;
✓. Before starting rhGH treatment, height was lower than -2 SDS compared with normal children of the same age and sex;
✓. All the subjects and their guardians signed the informed consent and the informed consent for genetic testing.

Exclusion criteria

✕. No efficacy and safety data were recorded after treatment with rhGH;
✕. A history of blood transfusion within 3 months before the collection of the genetic blood samples, or a history of bone marrow transplantation between rhGH treatment and the enrollment in this study;
✕. Other conditions that the investigator considered unsuitable for inclusion in this study.

What they're measuring

Genetic testing

Timeframe: At baseline

Trial details

NCT IDNCT05070234

SponsorChunxiu Gong

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-08-30

Contact for this trial

Bingyan Cao, doctor

13811748954 caoby1982@163.com

View on ClinicalTrials.gov More Small for Gestational Age Infant trials