Clinical Trials / Research Studies
Early Identification of Premature Babies at High-Risk for Disabilities
Why are we doing this research?
Very premature babies are at high risk for developmental disabilities such as cerebral palsy and learning disabilities. Unfortunately, these disabilities are not diagnosed until 2 to 5 years of age. Cincinnati Children's is conducting an observational research study, sometimes known as a clinical study, to 1) help improve our understanding of brain development and developmental disabilities in premature babies and 2) develop innovative methods at birth for early identification or prediction of learning disabilities and cerebral palsy/movement problems.Who can participate?
Mothers and their premature babies born before gestational age of 33 weeks who were delivered and/or are being cared for in the NICU at Cincinnati Children’s, Good Samaritan or University of Cincinnati Medical Center may be eligible to participate.Conditions
- Pregnancy
- Premature Babies
What will happen in the study?
If you decide that you want to participate in this study, we will have you read and sign a study consent form, after you have received all of the information and your questions have been answered.
Here are the things that will happen in this study:
- We will review your baby’s records and collect information about your health, as the mother, and ask you to fill out some questionnaires.
- Your baby will have a brain MRI when he/she is at a corrected gestational age of 41 weeks. An experienced neonatologist and/or research staff will accompany your baby.
You will be asked to:
- Follow up with developmental appointments for your baby, as part of routine clinical care until your baby is 2 years old. Doctors and developmental specialists will perform motor and cognitive tests to assess your child’s developmental level and share this information with our study team.
- Come in for one additional appointment when your child is 3 years old for non-invasive cognitive and motor tests and to complete some brief surveys to see how your child is doing at home.
What are the good things that can happen from this research?
Very premature babies are at high risk for developmental disabilities involving movement/motor skills, learning, and/or behavior. We identify such risks early enough (by 3 months corrected age) to give your baby a good chance at reducing his/her risk through targeted early interventions.
By conducting this study, we hope to more fully understand the benefits and limitations of advanced brain MRI and developmental tests. The information that we learn from this study could help us to improve the care and developmental outcomes for preterm babies.
What are the bad things that can happen from this research?
MRI exams are safe (no radiation). They can be noisy but we provide several measures to eliminate noise (e.g. ear plugs, headphones).Will you/your child be paid to be in this research study?
Families may receive up to $300 for time and effort. The MRI scan and developmental tests are free of charge for the family and paid by the study.Contact
Mary Deneka
513-517-0021
mary.deneka@cchmc.org
Neonatology and Pulmonary Biology
Cincinnati Children’s Hospital Medical Center
Study Doctor
Dr. Nehal A. Parikh
513-636-7584
nehal.parikh@cchmc.org
Neonatology and Pulmonary Biology
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039
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