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.