Clinical Trials / Research Studies

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, sometimes known as a clinical trial or clinical study, to learn more about factors such as genetics and environment that put very young children at a higher risk for food allergies and eczema.

Who can participate?

Pregnant women at least 18 years old who will be delivering their babies at UC, UC West Chester or Christ Hospital and are willing to be in the study with their baby for 3 years may be eligible to participate. Biological fathers may also be asked to participate.

Conditions

  • Pregnancy

What will happen in the study?

If eligible and once enrolled in this study, you will be in this study for 37 to 45 months, depending upon when you enroll.

Here are some of the things that will happen in this study (some will apply to your child and some may already have taken place depending on when you sign the informed consent).

Before the birth of your child, you will have an enrollment visit at the study site that will include taking your height and weight, asking questions about yourself and your medical history and collecting biological samples like blood, urine, hair, stool, skin swabs and skin tapes, nasal swabs, vaginal swabs, and saliva.

At delivery, a blood sample will be collected from the child’s umbilical cord after the cord is detached from your child. At 1 to 2 days after delivery, before your child leaves the hospital, several biological samples (skin swabs, skin tapes, and stool) will be collected. If these samples are not collected at the hospital, study staff may be able to collect them at your child’s first visit to the pediatrician or at a home visit during your child’s first week of life.

When your baby is 2, 5, 12, 24 and 36 months, you will be asked to bring him/her to the clinic at Cincinnati Children’s. At these visits, the study team will collect biological samples (blood, urine, stool, hair, skin swabs, skin tapes, nasal secretion samples and nasal swabs) from your child. Beginning at 5 months, the visits will also involve allergen skin testing to foods, and at 12 months, skin tests for environmental allergens will be completed. You will also be asked to collect home dust, water samples and stool samples between visits. Depending on your child’s history of exposure to a food, past food allergy symptoms, and the results of the allergen skin test, your child may be asked to have an oral food challenge at one or more visits to confirm the diagnosis of an allergy to a specific food.

Throughout the study, you will complete questionnaires related to you and your child’s health, diet, and environment. You will be asked to complete some questionnaires that you will access over the internet at home on your smart phone, tablet, or personal computer. Other questions will be completed at the clinic during study visits.

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 and your baby may not have a direct benefit from being in the study. He/she could potentially benefit from an early detection of allergies. Knowing what foods are safe to eat can improve quality of life and possibly prevent the future development of a food allergy.

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

You and your child would have little to no risk from participating in this study. Possible risks and discomforts will be discussed with those interested in learning more about the study.

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

Participants will be compensated for time and effort.

Contact

Contact Us.Kim Kersey
researchob@uchealth.com
513-584-2585

Study Doctor

Contact Us.Gurjit Khurana Hershey, MD
Division of Asthma Research
Cincinnati Children’s