Study for Pregnant Women and Their Infants
Study for Pregnant Women and Their Infants
Why are we doing this research?
Cincinnati Children's is conducting a research study to gain information about how the natural immune factors of mothers and babies protect against influenza in a baby's first four years of life. The information we learn from this study may help doctors to develop better vaccines in the future.Who can participate?
Pregnant women at least 18 years old who:
- Are 34 or more weeks pregnant
- Agree for their baby to have study follow up until they are 4 years old
Conditions
- Pregnancy
- Adult Studies
What will happen in the study?
This study includes 1 home visit when your baby is 2 weeks old, and visits to Cincinnati Children’s. You and your baby will come in for study visits when your child is 6 weeks, after each flu season (May-August),if your child develops the flu or is vaccinated for the flu until he/she has been followed through 3 full flu seasons, which could be up to 4 years old depending upon their birth month.
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 a blood sample
- At birth, we will:
- Collect cord blood
- During your home study visit, we will:
- Review what will happen in the study
- Ask questions
- Collect breast milk (if breastfeeding) and your baby’s stool and nasal and cheek 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, saliva and stool sample
- Weekly, you will be asked to collect and send by courier, your baby’s nasal swab samples. You will send stool sample once a month by courier
- Weekly, you will let us know by text message if your baby is having a 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. The potential benefits from participating in this study include learning how to correctly measure your child’s temperature with a thermometer which will be supplied. Also, you will be given influenza test results that your doctor could use to guide medical care decisions in the future. Overall, we will learn more about influenza illness in children and possibly prevent illness in the future.
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 $3,000 if all study procedures are completed over the four years of the study.
Study Doctor
Mary Allen Staat, MD, MPH
Cincinnati Children’s Hospital Medical Center
3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
© 1999-2024 Cincinnati Children's Hospital Medical Center. All rights reserved.
