What is the OBOE Study?
The Outcomes of Babies with Opioid Exposure (OBOE) Study is a research study that will help us learn more about how babies grow, develop, behave, and learn. Mothers may take opioids, a type of drug used to reduce pain, when they are pregnant.
As part of the study, we are looking at babies whose mothers did not take opioids during pregnancy. We are also looking at babies whose mothers took opioids during pregnancy.
If I join this study, what do I need to do?
If you agree to be in this study, we will work with you to:
- Review and sign a consent form
- Collect a piece of your baby's umbilical cord from the hospital where you gave birth. This piece of the cord would be thrown away if you were not in the study
- Collect information about you and your baby.
- Fill out some surveys about yourself.
- Schedule your baby for three MRI scans (0-1 month, 6 months, 2 years)
- Schedule a visit to your home when your baby is 12 months old for a developmental assessment.
- Schedule a phone call when your baby is 18 months old to ask some questions.
- Complete a developmental assessment at the 2-year visit.
How long does the study last?
You and your baby's participation in the study lasts for 2 years. Some parts of the study can be completed from your home.
What is an MRI?
MRI stands for magnetic resonance imaging. MRIs are a way to take scans - or pictures - of organs in the body with the use of a magnet.1
MRIs do not use radiation.
Are MRI scans safe for babies?
Based on all the medical information available, MRIs are not harmful to babies.1
How loud are OBOE Study MRI Scans?
MRI machines are noisy. Babies in the OBOE Study wear earmuffs. Wearing this type of ear protection reduces the sound of the scan.
How does the OBOE Study protect my baby's hearing during the MRI scan?
Babies who are getting an MRI scan as part of the OBOE Study wear earmuffs to block out the sound. Wearing ear protection reduces the noise in an MRI scan. MRI scans are not harmful to a baby's hearing.1
Will my baby be given medicine before the MRI scan?
Your baby will not get any medicine before the scan. For the first 2 scans, the OBOE Study uses a "feed and swaddle" method. This means babies are fed and swaddled in a blanket before their scan, leaving them full and sleepy to keep them as comfortable as possible. We will wait for your baby to fall asleep because it is important that your baby stays still during the MRI. To help get your baby to sleep, we ask that you delay naps and feeding before the MRI.
For the last MRI at age 2, we will schedule it at a time that is good for you. Evening around bedtime is usually the best time for an MRI scan because 2-year-old children start to get sleepy.
What happens if my baby wakes up during the MRI scan?
If your baby wakes up and cries, the scan will be stopped, and we will try and get your baby to fall back to sleep and then start the scan again. If your baby cries or is unable to fall asleep, we will stop the scan. If the scan is not completed, we may ask you to come back and try again later.
How long does the OBOE Study MRI scan take?
Each scan takes about 1 hour to complete. To allow enough time to get your baby to sleep and get the MRI images needed, we will schedule extra time for your appointment.
1Reference: University College of London. MRI Shortly After Birth.