91´óÉñ

Observational Study on Growth in Children With Short Stature

Studying Growth Patterns in Kids with Short Stature</h2>\r\n<p>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.</p>\r\n"}} id=text-e2875b678b class=cmp-text>

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</h2>\r\n<p>91´óÉñ Children’s Health, Pensacola | <b>Enrolling&nbsp;&nbsp;</b><br>\r\n&nbsp;</p>\r\n<h2>Participant&nbsp;Eligibility</h2>\r\n<p>Clinical trials have inclusion and exclusion requirements that determine eligibility. Key requirements are listed below. Please note there may be additional qualifications.</p>\r\n<p><b>At the time of consent, participants must be:</b>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<b></b></p>\r\n<ul>\r\n<li>Ages 2 to 14 years old (female).</li>\r\n<li>Ages 2 to 16 years old (male).</li>\r\n</ul>\r\n<h2><br>\r\nAbout the Study</h2>\r\n<p><b>Formal Study Name:&nbsp;</b>A Multicenter, Observational Study to Characterize Growth in Children with Idiopathic Short Stature</p>\r\n<p><b>Study Type: </b>Observational&nbsp;(researchers observe and record without intervening)</p>\r\n<p><b>Study ID:&nbsp;</b>2231160</p>\r\n<p><b>Sponsor/Coordinating Site:&nbsp;</b>&nbsp;BioMarin Pharmaceutical</p>\r\n<p><b>Start Date:&nbsp;</b>August 2024</p>\r\n<p><b>Completion Date (estimated):&nbsp;</b>December 2040</p>\r\n<p><b>Enrolling Healthy Volunteers?&nbsp;</b>No<br>\r\n&nbsp;</p>\r\n<h2>What’s Involved</h2>\r\n<p>During this study, your child may have up to&nbsp;38 visits. Some of the tests and procedures are similar to what happens during regular care, like&nbsp;vital signs, height and weight checks, and physical exams. Others are specific to the study, such as&nbsp;questionnaires about your child’s quality of life.</p>\r\n<p>Other requirements include:</p>\r\n<ul>\r\n<li><b>Blood samples</b>&nbsp;will be collected&nbsp;twice: Once during the screening visit and again on Day 1. The total amount of blood taken during the study is&nbsp;about 10 mL&nbsp;(roughly two teaspoons).</li>\r\n<li><b>Height and weight</b>&nbsp;will be measured at&nbsp;every study visit.</li>\r\n</ul>\r\n"}} id=text-1a4b9d24f9 class=cmp-text>

Study Location | Status

91´óÉñ Children’s Health, Pensacola | EnrollingÌýÌý
Ìý

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
Ìý

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 91´óÉñ to improve care through research. Clinical trials like this one are&nbsp;shaped by the expertise&nbsp;of our medical teams and research programs. Learn how related research and clinical care support, and are strengthened by, studies like this one.</p>\r\n"}} id=text-49958a91be class=cmp-text>

This study reflects our broader commitment at 91´óÉñ 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.

More About Clinical Trials

Learn what to expect from a clinical trial&nbsp;—&nbsp;how they work, why they matter, and what to consider when deciding if one is right for your child.</p>\r\n"}} id=text-b76b922dbb class=cmp-text>

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 from&nbsp;91´óÉñ KidsHealth<sup>®</sup></h2>\r\n"}} id=text-80a7334117 class=cmp-text>

Learn About Your Child’s Growth fromÌý91´óÉñ 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 91´óÉñ KidsHealth.</p>\r\n"}} id=text-115c011bc5 class=cmp-text>

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 91´óÉñ KidsHealth.