Why was my baby asked to participate in the study?

Babies who are born within 4 weeks of their due date are eligible to participate in the study if at some time before or during their birth they appeared stressed. Evidence of this stress is obtained by Apgar scoring done right after birth and from the amount of acid in the umbilical cord blood.

What happens if we participate in the study?

When the clinical team thinks that it is safe for your baby to leave the nursery, he or she will be taken for an MRI (magnetic resonance imaging) in the hospital within 6 days after birth. We take MRI pictures of the babies' brains within this early time window, because we would like to see whether we could recognize any changes in the brain that might happen after stressful birth early on. We hope that with the future development of drugs and procedures that can protect the affected babies' brains, we will be able to identify those babies who would benefit the most from treatment.

Your baby will also have free neurological exams and developmental (or IQ) tests starting at 3 months of age until early school age by child neurology experts and developmental psychologists. For the detailed description of these exams, click here. At the time of the 3-month follow-up exam, you may choose to have a follow-up MRI scan done for your baby as an optional part of this outpatient visit. This scan will help us to evaluate how the brain has responded to any injury that might have occurred. After each follow-up exam, we will send you a brief summary of the results.

For a complete list and explanation of study procedures, their potential risks, discomforts, and benefits please refer to the consent forms in English (doc) and in Spanish (doc).

How safe is the MRI?

Occasionally, babies move their head so much that the MRI scans can not be evaluated afterwards because the motion makes it hard to get a thorough look at the baby’s brain, therefore we won’t be able to tell you if there were any changes in the brain. In order to prevent this, the doctor accompanying your baby might sedate your baby when necessary if you agree to it. The drug used is a routinely used drug that doctors use in the nursery when babies get agitated and the sedation levels are kept to the minimum. Your baby will be monitored continuously, whether or not he or she gets sedation, to ensure his or her safety.

Do I need to pay for any of the exams?

No. All of the testing associated with the BAMRI study, such as the MRI, neurological exams and developmental (IQ) testing, are paid by the government funding that supports our research team, and will not be billed back to you or your insurance. In addition, we will give you free parking stickers each time you come back to the hospital for the study, as well as reimburse your gasoline, bus or taxicab costs. We will also give your child age-appropriate toys during the nursery course, and at all the follow-up visits; these gifts will be the total equivalent of $75 in value. If you were traveling from far for the follow-up exams, we will reimburse the airfare and lodging costs for your child and one accompanying parent. This is our way of saying thank you to you!

What are the benefits for my baby or me when we enroll in the study?

Throughout the study, your child will receive free testing by MR experts, child neurologists and psychologists that may help to identify health concerns early on. The exams may also bring health issues to light that help you to better understand and care for your child.

After each exam, we will send you a brief summary of the neurological exams and the developmental (IQ) tests for your child. In our result letter sent to you, we might recommend further evaluation by your local pediatrician or a child specialist, since the information we obtain is for research purposes only and is not to be used or substituted for a full health care visit.

Finally, as a participant in the BAMRI study, you and your baby will help advance knowledge about how MRI can be used to predict long-term outcome in babies who have experienced birth stress. We hope that this knowledge will lead to better care and treatment for these babies in the future.

What are the 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.

Can you tell me more about the babies who are already enrolled in the study?

While we protect our individual study babies’ and their families’ privacy and we will not give out any identifying information about them outside our research team, we can give you the general statistics of our study group so far:

• As of April 2007, we have studied over 220 babies with MRI who appeared to be stressed at birth and compared their brain MRI with 18 babies’ MRI who did not appear to be stressed at birth as our control group.
• Although we only enroll babies who were either born at or transferred to UCSF, our babies come from all over Northern California and Nevada and beyond (some of our babies are now in Hawaii, Michigan, Washington and even Indonesia)!
• For about 2/3 of the mothers this was their first baby. About 1/5 were having a second baby, and for the rest this was at least their third child.
• Mothers range in age from 15 to 43 years, with an average age of 28 years.
• Of the 161 babies, 59% are boys and 41% are girls.
• The birth weight of the babies ranged from 1625 gms to 5370 gms with an average of 3357 gms.
• As you know, it is very important for the babies to come in for their follow-up exams at ages 3 months, 1 year, 2.5 years, 4 years and 8 years. We appreciate how hard it is to make these trips, especially for those coming from farther away. We are pleased that our follow-up rates are about 95% for the 3-month and one year exams, and about 85% for the 2.5-year and 4-year exams. We have found that those who have "stuck it out" through the earlier exams are generally still "hanging in there" for the 4 and 8-year exams - thanks!

What are the results of the study do 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.

Whom can I contact if I have more questions about the study?

Please direct all questions to Dr. Agnes Bartha, clinical research fellow, either by calling her at 415-514-3277 or emailing her. She’ll be happy to answer any questions or feedback you might have about the study and this web site.

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