Clinical Trials / Research Studies

Clinical Trials / Research Studies

Study for Infants Going Into Their First RSV Season This Fall

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to look at a study medication to see how safe it is and whether it works to prevent respiratory syncytial virus (RSV) disease in healthy babies. RSV is the most common cause of lung infection in babies and young children.

Who can participate?

Babies born at 35 weeks or later who:

  • Are going into their first RSV season (October to November 2020)

and

  • Have no known history of RSV infection or lung diseases

Conditions

  • Healthy Infants, Children and Adolescent Studies
  • Chest and Lungs - Respiratory Tract

What will happen in the study?

This study includes 6 or 7 study visits over 17 months. In this study, your baby will randomly either receive the study medication or placebo.

You, as the parent or guardian, will bring in your baby for the following:

  • In-person clinic visits at Cincinnati Children’s which will include:
    • Screening and dosing visits (this can be done in one visit or two)
    • A physical Exam
    • A blood draw of about 1.5mL (1/3 of a teaspoon)
    • A dose of study drug or placebo
    • A check of vital signs
  • Five additional clinic visits over the first year of the study which will include:
    • A check of vital signs
    • A physical Exam
    • A blood draw of about 1.5mL (1/3 of a teaspoon) at visits 3, 5 and 6

And you will have:


  • Follow-up phone calls which will be:
    • Every 2 weeks for about the first 6 months
    • Once a month for the next 6 months
    • Then every 2 weeks for the remainder of the study

You 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.

What are the good things that can happen from this research?

Your baby may not have a direct medical benefit from participating in this study. However, if the study medication is effective and your baby is part of the group who receives it, he/she could be protected from getting RSV.

Even if there is no benefit to your baby, we may learn information that will help other children.

What are the bad things that can happen from this research?

As with any study medication, there could be possible side effects. These include a small chance of skin rash, itching, pain, swelling, redness or bruising at the injection site, and a chance for pain, swelling, redness or bruising at the blood draw site. We will discuss other possible risks or discomforts with you.

Will you/your child be paid to be in this research study?

Families will receive up to $370 for at least 7 study visits over 17 months.

Contact

Contact Us.

Cathy Grisby
513-803-0950
perinatalresearch@cchmc.org
Neonatology and Pulmonary Biology
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.

Vivek Narendran, MD
Neonatology and Pulmonary Biology
Cincinnati Children’s Hospital Medical Center