Observational Study on Growth in Children With Short Stature
Studying Growth Patterns in Kids with Short Stature
The purpose of this study is to learn more about how children with idiopathic short stature grow. After your child has been in this study for at least six months, you may be offered the option for your child to exit this study and enroll in a different study with growth promoting agents. Otherwise, your child may continue in this study until they are aged 16 for girls or 18 for boys.
Study Location | Status
ÎÞÂëרÇø Children’s Health, Pensacola | EnrollingÌýÌý
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ParticipantÌýEligibility
Clinical trials have inclusion and exclusion requirements that determine eligibility. Key requirements are listed below. Please note there may be additional qualifications.
At the time of consent, participants must be:ÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌý
- Ages 2 to 14 years old (female).
- Ages 2 to 16 years old (male).
About the Study
Formal Study Name:ÌýA Multicenter, Observational Study to Characterize Growth in Children with Idiopathic Short Stature
Study Type: ObservationalÌý(researchers observe and record without intervening)
Study ID:Ìý2231160
Sponsor/Coordinating Site:ÌýÌýBioMarin Pharmaceutical
Start Date:ÌýAugust 2024
Completion Date (estimated):ÌýDecember 2040
Enrolling Healthy Volunteers?ÌýNo
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What’s Involved
During this study, your child may have up toÌý38 visits. Some of the tests and procedures are similar to what happens during regular care, likeÌývital signs, height and weight checks, and physical exams. Others are specific to the study, such asÌýquestionnaires about your child’s quality of life.
Other requirements include:
- Blood samplesÌýwill be collectedÌýtwice: Once during the screening visit and again on Day 1. The total amount of blood taken during the study isÌýabout 10 mLÌý(roughly two teaspoons).
- Height and weightÌýwill be measured atÌýevery study visit.
How This Study Fits in
This study reflects our broader commitment at ÎÞÂëרÇø to improve care through research. Clinical trials like this one areÌýshaped by the expertiseÌýof our medical teams and research programs. Learn how related research and clinical care support, and are strengthened by, studies like this one.
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More About Clinical Trials
Learn what to expect from a clinical trialÌý—Ìýhow they work, why they matter, and what to consider when deciding if one is right for your child.
Learn About Your Child’s Growth fromÌýÎÞÂëרÇø KidsHealth®
Growth is a normal part of childhood, but it doesn’t always follow a straight line. Learn what to expect as your child grows, how to support healthy development, and when to talk to a doctor, from the experts at ÎÞÂëרÇø KidsHealth.