Infant, Small for Gestational Age Clinical Trial
Official title:
Non Interventional Study on the Follow-up, by Specialists, of Short Children Born Small for Gestational Age and Treated With SAIZEN®- SEPAGE Study
This one-arm, multi-centric, non-randomized, observational, open label, prospective study was designed to study short subjects born SGA, by pediatricians, endocrinologists or physicians in private, mixed private and hospital practice treated with Saizen.
The term "small for gestational age" (SGA) is a pathological medical condition known since
about two decades supported by two consensus conferences of 2001. It inhibits the height
and/or weight of the child at birth without prejudging the mechanisms that alter these. This
study will be carried out by hospital pediatricians, endocrinologists or physicians in
private, mixed private and hospital practice in metropolitan France. Subjects will be
monitored by doctors in accordance with the normal scope of follow-up of pathology until
their final growth and until they reach adult height and/or until the treatment is
discontinued. The participating doctors will include all the short SGA subjects coming for
consultation or the follow-up (for less than 12 months) of their treatment by Saizen in this
study. The inclusions will take place over a period of 21 months.
OBJECTIVES
Primary objective:
- To describe the characteristics of short children born SGA (SGA subjects) treated with
Saizen
Secondary objectives:
- To describe the terms and conditions for the prescription of Saizen in terms of dosage,
duration of treatment, reason for discontinuation and compliance
- To describe the effects of Saizen on growth and final height
- To describe the tolerance of Saizen. For each subject and during each visit, the
participating doctor will complete an electronic data collection form.
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Observational Model: Cohort, Time Perspective: Prospective
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