Clinical Research Study Viewer

Early Prediction Study

Overview:
The Early Prediction study is a follow-up study to the Perinatal Brain Injury Magnetic Resonance Imaging (PBI-MRI) study. We are trying to understand what causes brain injury and abnormal brain development in premature infants. We also are hoping to find a way using advanced MRI (Magnetic Resonance Imaging) to predict problems that premature infants will have so that we can help them develop better.

In the Early Prediction Study, we will be doing an advanced MRI at the age the preterm infant would have been born at if carried to term. We will then follow the infant’s development until at least the age of three years old.

All MRI results are shared with the family as well as the infant’s doctors.

Study Updates:
As of May 2014, we are preparing to launch this study within the next year. Our plan is to enroll 272 infants who were born at less than 32 weeks of gestational age, from 4 local hospitals.

Contact Information:
Please contact Jennifer Notestine at Jennifer.Notestine2@NationwideChildrens.org or 614-355-6634 for more information.

Frequently Asked Questions:

  • I am interested in the study. Can I go ahead and sign the consent form?
    No, the consent must be signed in the presence of a study staff member. Contact Jennifer Notestine, Julie Gutentag, Patty Luzader, or Dr. Parikh to sign the consent.
     
  • I want to do the study, but I’m not at the hospital. Can I give consent by phone?
    Unfortunately, we are not permitted to obtain phone consent with this study. We can talk with you and set-up an in-person meeting to discuss the study and answer any questions you may have.
     
  • MRIs are loud- what do you do to protect the baby from noise?
    We do several things to help shield the infant from noise. We use silicone ear putty secured in the ear. We cover the ear with an ear muff to further reduce noise. We also cover the ears with ear muffs and padding to further cut down on noise during the scanning process.
     
  • How do you ensure the infants are safe during the MRI?
    A study nurse (who is an experienced NICU nurse) will accompany your baby during the scan - your baby is monitored for heart rate and pulse oximeter during the MRI. If your child is still using oxygen a doctor involved with the study will also be present during the MRI.
     
  • Are parents allowed to be present in the MRI?
    Parents do not go into the MRI scanner area because of safety reasons. However, they are welcome to stay in a nearby waiting room. Study staff will update parents periodically on how the infant is doing.
     
  • Is the baby being exposed to radiation during MRI?
    No - the MRI testing uses a giant magnet. The MRI does not use radiation, and it is safe for infants.
     
  • What if my baby does not hold still during the MRI?
    Study staff will swaddle the infant and give the infant a pacifier if needed. Infants will be fed and diaper changed if needed before the testing to help the infant be still. Study staff will help the infant to fall into natural sleep for scanning. If the infant wakes, pacifier and soothing is offered. The infant may be given a small amount formula, if thought that he/she is hungry. If the infant still will not sleep for scan after attempts made, the scan will be cancelled. This is not a common occurrence.
     
  • Will you give my baby medicine to make him/her sleep during the MRI?
    We do not give any sedation or medication to make the infant sleep. We attempt to help the infant fall asleep naturally.
     
  • How long does the MRI take?
    Generally, the MRI takes between 45 minutes up to 1 ½ hours to complete, depending on how well the infant sleeps during the testing.
     
  • Who can I contact with questions about the study?
    You can call either Jennifer Notestine at 614-355-6634 or Dr. Nehal Parikh at 614-355-6657. 

Nationwide Children's Hospital
700 Children's Drive Columbus, Ohio 43205 614.722.2000