Study for Pregnant Women and Their Infants

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to gain information about how the natural immune factors of mothers and babies protect against infections in a baby’s first two years of life. The information we learn from this study will help doctors to develop better vaccines in the future.

Who can participate?

Pregnant women 18 to 45 years old who:

  • Are 34 or more weeks pregnant
  • Plan to deliver at the University of Cincinnati Medical Center (UCMC) or The Christ Hospital
  • Agree for their baby to have study follow up until they are 2 years old

Conditions

  • Pregnancy

What will happen in the study?

This study includes 1 home visit (when your baby is 2 weeks old) and 5 study visits (when your baby is 6 weeks, 6 months, 12 months, 18 months and 24 months old) to Cincinnati Children’s over 2 years.

Here are some of the things that will happen in this study:

  • Prior to giving birth, you will:
    • Answer questions about your pregnancy and medical history
    • Submit blood, saliva and nose swab samples
  • At birth, we will:
    • Collect cord blood
    • Give you a stool sample collection kit and instructions about how to collect your baby’s first bowel movement (meconium)
  • During your home study visit, we will:
    • Review what will happen in the study
    • Ask questions
    • Collect breast milk and your baby’s stool and nasal swab samples
  • At your study visits at Cincinnati Children’s, we will:
    • Ask you questions
    • Collect breast milk, and a small amount of your baby’s blood and a saliva sample
  • Weekly, you will be asked to collect and send by courier, your baby’s stool and nasal swab samples.
  • Weekly, you will let us know by text message if your baby is having diarrhea, vomiting, cough or fever.
  • We will call and text you a few times to ask questions and to see how your baby is doing.

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?

You or your child will not receive a direct benefit from being in this study right now. However, when we complete the study, we hope that we will know more about common childhood diseases.

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

Possible risks and discomforts will be discussed those interested in learning more about the study.

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

Participants may receive up to $1,555 if all study procedures are completed over the two years of the study.

Contact

Contact Us.Morgan Bamberger
513-584-4019
bamberme@ucmail.uc.edu

Study Doctor

Contact Us.Ardythe L. Morrow, PhD
Cincinnati Children’s Hospital Medical Center