Why am I being asked if I want to consider this study for my baby?

You are being asked to allow your baby’s participation in this study because your baby has congenital heart disease that will require an operation and is at risk of brain injury.

What is this study about?

The purpose of this study is to determine if pictures of the brain obtained by a magnet (MRI test), which does not involve any radiation, can help detect brain injury in babies who need surgery for congenital heart disease.

What will happen if my baby is enrolled in this study?

• Your baby will have two MRI tests of his/her brain. The first MRI test will happen when your baby’s doctor says it is safe for your baby to be moved off the unit and before his/her heart operation. The second MRI test will be done after your baby’s heart operation.
• Your baby will be transported in a specially built incubator for newborns to another area of the hospital for the MRI tests. This incubator will keep your baby warm and will minimize any disturbance during that scanning procedure
• A follow up visit will be arranged at a convenient time for you and your baby when your baby is 12 months, 30 months, and 4 years of age. The research study doctors will do neurological and developmental clinical evaluations.

Are there benefits associated with enrollment?

There may or may not be a direct benefit to your baby from participating in this study. However, the knowledge and medical advances learned from this study will help with the treatment of future newborns with congenital heart disease.

Are there risks associated with this study?

For a complete list of and explanation of potential risk and discomforts, please refer to section C. of the consent form in English and Spanish. The consent form will be discussed with you and given to you in writing at the time of your enrollment along with Research Subjects’ Bill of Rights also available in English and Spanish.

How many children have enrolled in the study?

As June 2005, 60 families consented for enrollment and 57 have been enrolled and study.

Is there any charge for the exams?

You will not be charged for any of the study procedures. The costs of the procedures and all tests associated with this study will be covered by the study. When you come for follow-up exams. We will give you parking stickers/ cab fare reimbursement to cover your transportation.

Will my baby need to be sedated?

Occasionally, babies undergoing MRI exams move so much that the MRI scans can not be read afterwards because of the motion makes it hard for us to get a good look at that baby’s brain. In order to prevent this, the nurses sometimes sedate babies when necessary. The sedation levels are very low, and your baby will be monitored continually by doctors and the neonatal nurses, whether or not he or she gets sedation, to ensure his or her safety.

back to top