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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 GH treatment in this study. The inclusions will take place over a period of 12 months.
- To describe the characteristics of short children born SGA (SGA subjects) treated with Saizen
- 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.
Observational Model: Cohort, Time Perspective: Prospective
Infant, Small for Gestational Age
Merck Serono Investigational Site
Aix en Provence
Published on BioPortfolio: 2014-07-23T21:09:54-0400
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An infant having a birth weight lower than expected for its gestational age.
The event that a FETUS is born alive with heartbeats or RESPIRATION regardless of GESTATIONAL AGE. Such liveborn is called a newborn infant (INFANT, NEWBORN).
An infant whose weight at birth is less than 1000 grams (2.2 lbs), regardless of gestational age.
An infant whose weight at birth is less than 1500 grams (3.3 lbs), regardless of gestational age.
The death of a FETUS of GESTATIONAL AGE 28 weeks or more, or the death of a live-born INFANT less than 28 days of age.
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