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A Pharmaco-epidemiological Study of Short Patients Born Small for Gestational Age (SGA), Treated With Saizen® (Recombinant Somatropin)

2014-07-23 21:09:54 | BioPortfolio

Summary

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.

Description

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.

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Infant, Small for Gestational Age

Intervention

recombinant somatropin

Location

Merck Serono Investigational Site
Aix en Provence
France

Status

Recruiting

Source

Merck KGaA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:54-0400

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Safety and Efficacy of Somatropin (rhGH) in Short Children Born Small for Gestational Age (SGA)

This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (S...

Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age (SGA)

The objective of this surveillance is to collect Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).

Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)

To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.

Growth Hormone Treatment in Short Children Born Small for Gestational Age

Comparison of 2 different doses of human growth hormone treatment on change in height after 1 and 2 years of treatment.

A Study of Recombinant Human Growth Hormone Injection(JINTOPIN AQ)for Short Children With Small for SGA

To preliminary assess the efficacy and safety of recombinant human growth hormone injection on the treatment of small for gestational age (SGA), and determine the best dose.

PubMed Articles [6847 Associated PubMed Articles listed on BioPortfolio]

Comparison of diurnal variations, gestational age and gender related differences in fetal heart rate (FHR) parameters between appropriate-for-gestational-age (AGA) and small-for-gestational-age (SGA) fetuses in the home environment.

To assess the influence of gender, time of the day and gestational age on fetal heart rate (FHR) parameters between appropriate-for-gestational-age (AGA) and small-for-gestational age (SGA) fetuses us...

Better Diet Quality during Pregnancy Is Associated with a Reduced Likelihood of an Infant Born Small for Gestational Age: An Analysis of the Prospective New Hampshire Birth Cohort Study.

Birth weight has a U-shaped relation with chronic disease. Diet quality during pregnancy may impact fetal growth and infant birth weight, yet findings are inconclusive.

Iodine Status during Pregnancy in a Region of Mild-to-Moderate Iodine Deficiency is not Associated with Adverse Obstetric Outcomes; Results from the Avon Longitudinal Study of Parents and Children (ALSPAC).

Severe iodine deficiency during pregnancy has been associated with pregnancy/neonatal loss, and adverse pregnancy outcomes; however, the impact of mild-to-moderate iodine insufficiency, though prevale...

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Genetic Analyses in Small for Gestational Age Newborns.

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Medical and Biotech [MESH] Definitions

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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