Research Studies for Children 2 to 11 Years Old Diagnosed With Certain Growth Disorders
Why are we doing this research?
Cincinnati Children’s is conducting research studies, sometimes known as a clinical trials or clinical studies, to compare the safety and effectiveness of daily growth hormone injections to once weekly long-acting growth hormone injections.
Who can participate?
Pre-pubertal children 2 years and 26 weeks to 11 years old who are diagnosed with certain growth disorders (e.g., growth hormone deficiency, small for gestation age, Noonan syndrome, Turner syndrome, and idiopathic short stature) may be eligible to participate.
What will happen in the study?
In these studies, children who are eligible to participant will start their growth hormone treatment through the study and be required to attend on-site study visits about every 3 months. Each visit lasts about 2-3 hours on average.
In the first year of the study, children are assigned either the FDA approved daily growth hormone medication or the study medication (once weekly long-acting growth hormone medication). After a period of one year in the study, all children taking the daily growth hormone medication will start taking the once weekly long-acting medication.
- Have blood drawn at multiple visits (some of them will require fasting).
- Have height, weight, body composition and vital signs (blood pressure, breathing rate, heart rate) taken.
- Have physical exams performed by the study doctor (some will include an exam to check for signs of puberty).
- Have electrocardiograms (ECG) or echocardiograms (TTE) performed at some of the visits depending on your diagnosis.
- Have x-rays taken of their hand.
- Be trained on the use and care of the study medication (daily or weekly).
- Be required to log their daily or weekly injections into a study app on a cell phone
- Complete study questionnaires.
Families interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered at the first study visit.
What are the good things that can happen from this research?
Your child may or may not have a direct medical benefit. However, the information we obtain from this study may help us to learn more about long-acting growth hormone treatment safety and efficacy for children with growth disorders.
What are the bad things that can happen from this research?
There is some risk to participant in this research study. Most of the risks involved in this study are the same as the risks associated with taking growth hormone medication clinically. We will discuss possible risks and discomforts with parents or guardians interested in learning more about the study.
Will you/your child be paid to be in this research study?
Compensation varies by study, but participants will receive payment for their time and effort upon completion of each study visit. In addition, the study sponsor will provide the study medication, supplies, and cover the cost of all study related procedures and staff time. Compensation will be discussed in detail with parents or guardians interested in learning more about the study.