Why was my baby asked to participate in the study?
Babies are eligible to participate in the Premature Infant MRI Study if they were born at less than 33 weeks gestational age, provided they do not have a congenital infection, significant problems with their central nervous system, congenital metabolic disease.
What does my baby have to do to participate in the study?
When it is safe for your baby to leave the nursery, he or she will be taken to the radiology department for an MRI (magnetic resonance imaging) in a special incubator designed for newborns. The MRI scan uses a magnet - not harmful radiation - to take detailed pictures of your baby's brain while he or she is sleeping. The MRI will not cause pain to your baby, and it has been proven to be a very safe procedure.
Will my baby need to be sedated for the MRI?
Occasionally, babies undergoing MRI exams move so much that the MRI scans can not be read afterwards because the motion makes it hard for us to get a good look at the 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.
Is there any charge for the exams?
No. All the costs of the exams for the study are paid by funds from our grant. In addition, when you come for follow-up exams, we will give you parking stickers or bus/cab fare reimbursement to cover your transportation costs. All families are also given toys for their babies, which is really our way of saying thank you!!
Are there benefits associated with enrollment?
By participating in the PreMRI study, you and your baby will help advance knowledge about how MRI results may predict long-term outcome in premature babies. We hope that this knowledge will lead us to additional treatments for premature babies that will help to either prevent or treat brain injury.
Are there risks associated with enrollment?
For a complete list and explanation of potential risks and discomforts, please refer to section C. of the consent form in English and in Spanish. The consent form will be discussed with you and given to you in writing at the time of your enrollment along with the Research Subjects' Bill of Rights in English or in Spanish.
How many babies have been enrolled in the study so far?
As of July 2007, we have enrolled 233 babies in the Premature Infant MRI Study.
What are the basic statistics of the study?
- Of the babies enrolled, 47% females and 53% males.
- Because the Premature Infant MRI Study is funded by the National Institutes of Health, we need to keep track of the ethnic and racial origin of babies to make sure all categories are being included in the study. The ethnic makeup of our babies is as follows: 56% (n=131) white, 27% (n=63) hispanic, 8% (n=18) Asian, 6% (n=13) African American, 1% (n=3) American Indian, 3% (n=8) multiple or unknown.
- The mothers of our babies range in age from 14 to 46 with an average age of 30.
- The birth weight of our babies ranges from 450 grams (1 pound) to 2260 grams (4.97 pounds) with an average birthweight of 1140 grams (2.5 pounds).
- So far all of our babies have been born in California. 167 of the babies were born here at UCSF, and 66 were born at another California hospital.
- So far our follow-up rate for the PreMRI study has been very good--we have been able to do follow-up exams on all but 14 of the babies enrolled in our study. Thanks so much for helping us keep up with follow-up!
What are the results of the study so far?
Thanks to the strong commitment of our participating families, we have collected a unique set of clinical and imaging data so far. Please read what the major findings of the study were or follow the individual links to our published articles.