The goal of this study is to investigate early brain development in infants less than 1 year of ago who were born between 32 and 36 weeks gestation.

We are inviting families to participate in a Brown University research study of early brain development. The study involves taking brain pictures using Magnetic Resonance Imaging (MRI) during natural sleep (non-sedated), coupled with evaluations of general functional development (e.g. language, memory, and motor control). Participants are invited to attend up to 2 imaging and behavioural assessment sessions over the course of 1 year. This data will allow us to investigate if, and how, brain development differs in children born premature compared to child born of term.

What Is The Aim Of The Study?  What Are We Expecting To Learn With This Research?

Early brain and white matter development is crucial for normal brain function.  It allows the correct functioning of the complex brain systems required for such activities as coordinated movement, language, decision making, etc.  However, little is known about how this critical process occurs; and how if may differ in those children born premature.  The aim of this study is to answer these important questions.

Because neurodevelopment and myelination is a continuous process, the study is longitudinal in nature, comprising up to 2 imaging and functional evaluation sessions (depending on age at enrollment) over the course of 1 year (at approx. 3 and 9 months of age).  Acquiring data longitudinally will allow us to better determine how the brain develops over time.

Why Is This Research Important?

Premature infants face a number of challenges.  Prior studies have suggested altered brain volume and structure in adolescents who were born prior to 32 weeks gestation.  It is unclear if this is also true in infants born between 32 and 36 weeks (moderately premature).  We are particularly interested if there is evidence of change within the first year of life, when potential therapies would be most effective. 

To investigate possible early differences in brain development, brain images of participating infants will be acquired at 3 and 9 months of age (or any time up to 1 year of age), along with a behavioural assessment that assess your child’s vision, language and motor development.

MRI is a safe and non-invasive procedure that allows us to take detailed pictures of the brain.  All imaging sessions will take place at the MRI facility at Brown University (map), with your infant or toddler in the scanner for approximately 20 minutes. Prior to each imaging session (or on a separate day if more convenient), we will also perform a series of functional and behavioural assessments.  These will include assessments of your child’s language, vision and motor development, and are administered through play-like activities requiring approximately 45 minutes.  All participants will be reimbursed for their time and travel.

Can My Infant / Toddler Participate?

Yes! If your infant:

- Was born between 32 and 36 weeks.

- Is healthy and has normal hearing and vision.

- Has no metal is his / her body.

- is between 1 month 1 year of age.

To participate, or if you have any questions, please contact us on

(401) 863 - 7661, via email at baby_imaging_lab@brown.edu.

What Will Each Session Involve?

When we contact you, we will ask about your infant’s sleeping patterns and daily routine.  Sessions will be arranged so that we can perform some general functional assessments and then scan your infant or toddler near their normal nap or sleep time.  We will ask you to come to the center approx. 1 hour before their regular nap or sleep time, so that there is plenty of time to settle you and your child in the center and explain the general procedure.

We will leave you to settle in a private room before the scan.  We have a nappy changing station and a quiet room for feeding and relaxing so that your child can fall asleep undisturbed.  As soon as your infant starts showing signs of falling asleep, we will loosely swaddle and place them on the scanner table (outside of the scanning room).  Once they are in deep sleep, we will place Minimuff ear cushions and headphones over their ears to protect their hearing, tighten the swaddle a little and place soft foam wedges around their body to make sure they are comfortable and do not move during the imaging session.  The scan will last up to 30 minutes, depending on how long your infant sleeps. If your baby awakens during the scan, but remains calm and content, we will try to finish the scan session.

We have worked hard to minimize the sound of the MRI scanner, making it near silent.  There is a microphone and camera inside the scanner so that we can hear and see your child throughout the scan session.  If you choose, you may stay with your child in the scanner room.  Before entering the scanning room, we will screen you for metal and other MR contraindications and provide you with hearing protection. You can stop the study at any time.  If you think your child is unhappy or distressed, inform us and we will stop.

Following a successful scan, we will arrange a time for the behavioural assessment portion of the study.  Depending on your child’s age, a set of tasks designed to assess your child’s language, motor control and vision will be used.  These tests typically require less than 30 minutes to complete and will be administered in a play-like atmosphere.  We will also ask you to fill out some questionnaires regarding your babies temperament, your relationship with your baby and how you feel your baby is developing.  This information will be stored securely and information will be anonymised.  This session will be carried out in a large playroom at our lab at 229 Wayland Ave (corner of Wayland Ave. and Waterman Street).

Is MRI Safe For My Baby?

MRI is a safe and non-invasive technique that is commonly used to study the brain in infants, children and adults.  It does not involve radiation.  Instead, the MR scanner consists of a powerful magnet, which may attract certain metallic objects.  If your child has metal pieces in his/her body (for example, following an operation), they should not be scanned. 

How Long Will Each Session Last?

The functional assessments will last between 30 and 60 minutes.  The scan will last up to 30 minutes.  The whole session, including preparation time, feeding and settling your baby may last 1-2  hours.  You are free to end the session, for any reason, whenever you wish. 

Since development is a rapid process in young infants and toddlers, we would like to perform the functional assessments as soon as possible following the MRI scan, typically within 1-2 days.

How Should We Prepare For The Session?

We scan all infants during their natural sleep, without any type of sedation.  It is important that we schedule the session around your baby’s nap time, so that he/she falls asleep at the Centre.  It is important to make sure that your baby is awake when you arrive.  Since we will wait for your baby to fall asleep, you may be in the Centre longer than 3 hours.  Prior to your first visit, we will provide you with a tape/CD/DVD with the sounds of the MR scanner running the protocol we will use during your visit.  If possible, we ask that you play this as your child is falling asleep or napping during the week preceding your visit to help them become accustom to the sound of the scanner.

Where Do The Study Sessions Take Place?

The study sessions will take place at the MRI facility at Brown University (185 Meeting Street, Providence RI, 02906).  Imaging will be performed on a 3 Tesla (3T) Siemens MR imager.

How Many Times Will My Infant Be Scanned?

The study involves up to 2 scans at approximately 3 and 9 months of age.

To familiarize you and your child with the scanner environment, an additional session in a ‘mock’ scanner will be booked on a separate day prior to your first actual scan visit.  Although the mock scanner looks and sounds like a real imager, it does not have a magnetic field or the equipment necessary to record data.

What Do I Or My Baby Gain By Participating In The Study? How Do We Find Out The Results?

We sincerely appreciate the time you are giving up to participate in this study and will, therefore, reimburse you for your time and travel expenses.  You will also receive a copy of the images (playable on your computer or DVD player), a written report from the neuropsychologist, and a plush Brown bear.

Once the study is finished, we will send you a report of the overall findings.  As it is a longitudinal study, we will also send you any interim results of study progress and significant findings. The purpose of the MRI scan is not to make a clinical diagnosis - the images will not provide the same information as those obtained for clinical purposes.  However, in the unlikely event that anything unusual is noticed, the images will be forwarded to a trained and board certified neuroradiologist and you will be informed.  We will leave the decision of whether to forward this information and images onto your family doctor up to you. Other than passing this information to you promptly, the researchers will not be responsible for any further clinical management in this unlikely event.

When Can I Withdraw From the Study?

You can withdraw from the study at any time without need for justification.  We want to make sure that you and your child and happy and relaxed throughout the session and study.

All information we will obtain from you is strictly confidential. We will store the data of your child’s scans, functional evaluations and interviews, as well as GP details, anonymously and safely using secure computerized data storage systems at a secure location within the Barus & Holley Building on Brown University campus. Only members of the research team will have access to this anonymised information.

It is up to you to decide whether or not to take part.  If you do decide to take part, you will be given this information sheet and asked to sign a consent form. You will also be asked to sign the MRI addendum sheet on behalf of your child. If you decide to take part, you are still free to withdraw at any time, without need of justification.

If you agree to take part you may also be asked whether your are happy to be contacted about participating in future research studies.  Your participation in this study will not be affected should you choose not to be contacted about other studies.  A decision to withdraw at any time, or a decision to not take part, will not affect the standard of care you or your child receive.  You may withdraw your child’s data from the project at any time until it is transcribed for use in the final report.

If you have any questions regarding this research, please feel free to contact the lead researcher on this project,

Dr. Sean Deoni, PhD

Telephone: 401-863-7661.

Email: Baby_Imaging_Lab@brown.edu

If you have any questions with regards to yours, or your child’s rights as a research participant, please feel free to contact the Brown University Research Protections Office.

Brown University Research Protections Office.

Telephone: 401-863-3050.